Enanta Pharmaceuticals Inc (ENTA) News

IMHO - all these patents would be a significant value incentive for a merger or a buyout -

As of June 25, 2024 -

Apoptosis signal-regulating kinase 1 inhibitors and methods of use thereof

Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, ester, stereoisomer, tautomer, solvate, hydrate, or combination thereof: which inhibit the Apoptosis signal-regulating kinase 1 (ASK-1), which associated with autoimmune disorders, neurodegenerative disorders, inflammatory diseases, chronic kidney disease, cardiovascular disease. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from ASK-1 related disease. The invention also relates to methods of treating an ASK-1 related disease in a subject by administering a pharmaceutical composition comprising the compounds of the present invention. The present invention specifically relates to methods of treating ASK-1 associated with hepatic steatosis, including non-alcoholic fatty liver disease (NAFLD) and non-alcohol steatohepatitis disease (NASH).
Type: Grant
Filed: December 2, 2022
Date of Patent: June 25, 2024

Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Ruichao Shen, Jiang Long, Jun Ma, Xuechao Xing, Yong He, Brett Granger, Jing He, Bin Wang, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

https://patents.justia.com/patent/12018017

A series of studies using ASK1-deficient mice have indicated that ASK1 plays important roles in many stress-related diseases, including cardiovascular and neurodegenerative diseases, suggesting that small compounds that inhibit ASK1 activity could possibly be used for the amelioration of the development and/or progression of these diseases.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491083/

O/T ----

We need some LEVITY here. One of my favorite movie scenes.

Might as well continue to list patents as they are granted. Who know what leverage they'll have in a potential acquisition or merger?

Hepatitis B antiviral agents
Patent number: 12011425
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, esters, or prodrugs thereof: X-A-Y-L-R??(I) which inhibit the protein(s) encoded by hepatitis B virus (HBV) or interfere with the function of the HBV life cycle of the hepatitis B virus and are also useful as antiviral agents. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HBV infection. The invention also relates to methods of treating an HBV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: January 25, 2023
Date of Patent: June 18, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Yao-Ling Qiu, Xuri Gao, Jorden Kass, Hui Cao, Wei Li, Xiaowen Peng, Byung-Chul Suh, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

RSV competition
Shionogi's L inhibitor challenge study expected to be completed by Q3 - exactly the same as ENTA
I view this as the stiffest competition to ENTA's RSV programs

https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/e20240614.pdf

Keller : Indeed, Enanta’s compound is the closest competitor in terms of mechanism. As you understand, we
are also conducting challenge trials to collect clinical data. What we are confident about is that this targeting
mechanism allows us to rapidly reduce viral load and achieve efficacy.
We think that data will be available by the end of this year.

Muraoka : As for your compound S-337395, when will we see the clinical data on it?
Keller : The results of the challenge study are important data. They will come out later this fiscal year.
Muraoka : Is it the second or the third?
Keller : I think it will be in Q3.

FWIW - Addendum - Barbara Fiacco - ENTA, if only -

Represented Dana-Farber as lead counsel in second case against Bristol-Myers Squibb and Ono Pharmaceuticals, asserting claims for unjust enrichment and unfair competition for depriving Dana-Farber of its co-ownership rights under eight patents directed to cancer immunotherapy. On the eve of trial, in the face of Dana-Farber’s claim for hundreds of millions of dollars in damages, Defendants settled, making a substantial lump sum payment to Dana-Farber and agreeing to make potential additional payments, contingent on future events.

https://foleyhoag.com/people/fiacco-barbara/#Experience

ENTA has an outstanding litigator in their representation - Barbara Fiacco

Quote - The following Foley Hoag partners were also recognized for excellence in the industry in the following jurisdictions, and were described by IAM as:

Barbara Fiacco (National) and Donald Ware (MA) ranked in the Gold tier for litigation.

“Two of the most high-quality trial lawyers Boston has to offer,” and “A formidable team in life sciences litigation, securing multiple victories for the Dana-Farber Cancer Institute, resulting in significant payouts as well as co-ownership of groundbreaking cancer treatment patents.”

https://foleyhoag.com/news-and-insights/news/2024/june/foley-hoag-10-partners-recognized-in-2024-edition-of-iam-patent-1000/

https://foleyhoag.com/people/fiacco-barbara/

Here's the latest. Appears that ENTA is progressing well as of June 13. Comments?
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Since the HMPV program has been dropped I am impressed with the persuasive marketing and sales success of the legal firm that serviced all of these patents. I have always acknowledged the giant patent portfolio of Enanta, but is it in vain? Vanity -- hmm?

Two more for the books -

Patent number: 12006291
Abstract: The present invention relates to processes for preparing a Compound (1): or a pharmaceutically acceptable salt or solvate thereof. Compound (1) is useful as in many pharmaceutical agents, especially is useful as key intermediate in the synthesis of certain SARS-CoV-2 3CLpro inhibitors.
Type: Grant
Filed: January 10, 2023
Date of Patent: June 11, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Kaicheng Zhu, Tao Wang, Jiajun Zhang, Hui Cao, Ruichao Shen, Guoqiang Wang, George G. Wu, Yat Sun Or

Antiviral heterocyclic compounds
Patent number: 12006326
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, esters, or prodrugs thereof: which inhibit Human Respiratory Syncytial Virus (HRSV) or Human Metapneumovirus (HMPV) inhibitors. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HRSV or HMPV infection. The invention also relates to methods of treating an HRSV or HMPV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: August 24, 2022
Date of Patent: June 11, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Adam Szymaniak, Kevin McGrath, Jianming Yu, Tyler Mann, Long Nguyen, Kaicheng Zhu, In Jong Kim, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

June 11, 2024
Enanta Pharmaceuticals gets grant for macrocyclic compounds inhibiting coronavirus replication

....the patent outlines methods for treating viral infections, particularly coronavirus infections, by administering the disclosed compound. The methods include oral, subcutaneous, intravenous, or inhalation administration of the compound. Additionally, the patent covers inhibiting viral 3C protease or viral 3CL protease in a subject by administering the compound. The patent specifies the treatment of various strains of coronaviruses, including 229E, NL63, OC43, HKU1, SARS-CoV, and MERS coronavirus, highlighting the broad spectrum of antiviral activity claimed in the patent.

https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-gets-grant-for-macrocyclic-compounds-inhibiting-coronavirus-replication/

both parties submitted motion for summary judgement - ENTA for damages arguing facts are undeniable so no need for trial, PFE that patent is invalid or obvious that they didn't infringe and toss the case
There were some posts about this on the board w DD opining that most likely neither party wins on summary judgement (although I suppose someone can win in part and case still goes to trial)
things are coming to a head

Summary judgment hearing for whom?

sounds like the time of the hearing was changed

ELECTRONIC NOTICE Resetting Daubert and Motion for Summary Judgment Hearing. Motion Hearing set for 7/31/2024 10:00 AM in Courtroom 11 (In person only) before Judge Denise J. Casper. NOTE TIME CHANGE ONLY (Hourihan, Lisa)

Explanation needed. T.I.A.

Docket last updated: 10 hours ago
Thursday, June 06, 2024 Notice Setting or Resetting Hearing on Motion Thu 06/06 11:17 AM
ELECTRONIC NOTICE Resetting Daubert and Motion for Summary Judgment Hearing. Motion Hearing set for 7/31/2024 10:00 AM in Courtroom 11 (In person only) before Judge Denise J. Casper.

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

The fact that an antiviral course is short makes it not that challenging from a medical standpoint to stop things like statins while taking paxlovid, so the impetus for an EUA path is not really that justified. however if you have a drug without DDIs it makes it a no brainer to just Rx that over another drug given the hassle of going though med lists and figuring out what to hold for a week or so

It would have been nice if 235 was granted EUA for use in populations where DDI is of concern.

I don't know but ensitrelvir suffers from DDIs much like paxlovid and EDP-235 doesn't so even if it were to gain approval in the west (more of an uphill battle after the recent phase 3 readout), EDP-235 should still have appeal based on DDI alone. This is why shionogi is bringing forward another PI that is closer to 235 in its profile. Perhaps ensitrelvir fares better in the EU from a regulatory standpoint who knows
I don't know that a partner will view 235 as having a good chance of approval if the FDA insists on the 15 symptom endpoint so ironically it is better IMO if ensitrelvir gets the nod from FDA on the narrower symptom subset bc again 235 has the DDI advantage (and perahps an efficacy advantage we have to see the data from SCORPIO-HR)
If ENTA were to prevail in the paxlovid litigation they have more interest in ensitrelvir not making it to market though

Legitimate question, I am not clowning around. Does everyone agree that Shionogi's COVID assets, are all going to be limited to markets in Japan and some parts of Asia? With Enanta dropping its improved COVID program, and not demonstrating any success in partnering its EDP 235 asset it seems like Paxlovid is the cat's meow for now and the future.

Shionogi R and D day slides:
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/E_final.pdf

No new info on ensitrelvir
Slide 46 discusses a new PI for covid with fewer drug interactions and no teratogenicity which should be entering phase 2 soon
Slide 48 discusses their L protein inhibitor for RSV which is in a human challenge study so same stage of development as ENTA's L inhibitor.

It sounds like there may be some psychology involved, i.e., if there is more at stake, then in general a person will not want to be the sole decision maker. The follow-on psychological response is that when this goes to trial there will be a lot of average Joes on the jury hating big pharma, unless they credit Paxlovid with saving the lives of their loved ones, but of course those average Joes will be dismissed from the candidate pool.

Averages that include all US patent litigation (such as the ones you cited) would seem to be unreliable for a case like this one that has so much money at stake. Many patent cases have minimal commercial relevance, which intuitively ought to increase the likelihood of a summary judgment.

I think the odds of summary judgment in favor of PFE is higher than that for ENTA, but that the odds of no summary judgement for either is still the most likely outcome. The foundation for the active moiety does predate the pandemic after all bc the molecule is based on a structure designed for the virus that caused the earlier SARS outbreak in the early aughts. That said it does seem like the patent itself, if it stands, does cover paxlovid bc one of PFE's arguments that is public is that the patent was altered after the chemical structure of nirmatrelvir was revealed in 2021 so this could actually go in ENTA's favor as well if the judge really feel the patent shouldn't be invalidated

On April 6, 2021, at a virtual meeting of the American Chemical Society (“ACS”), Pfizer's scientists publicly revealed the chemical structure of nirmatrelvir.... It is Pfizer's position that significant revisions of the patent are based on Pfizer's work in developing nirmatrelvir, disclosed in the April 2021 presentation

https://casetext.com/case/enanta-pharm-v-pfizer-inc-2

In various locations on the internet there are declarations that the rate of summary judgment for a patent case is 66% and that the rate of summary judgments in favor of the patentee is around 30%. It is my hope that Enanta embarked on this suit expecting to go to trial and expecting to win.

My probability estimate of no summary judgment for either party is 85%, FWIW. (I am not a lawyer.)

Thx Mouton
I guess there are 3 obvious outcomes here. PFE wins summary judgment and case is over, ENTA can win summary judgement, or the judge doesn't grant it to either party and it goes to trial. The second possibility, however small, would be hugely bullish, and the third option would as well bc once it goes to trial I would think PFE is more likely to settle
I guess a 4th option is the judge grants summary judgement in part narrowing the scope of what goes to trial?
always good to get a lawyer's opinion here thx - I have no idea how to handicap any of these possibilities frankly, but it seems at least so far today the remote possibility of a judgement in ENTA's favor in the next 2-3 months is dawning on some investors

I've read the Bloomberg article, and Dewophile, you are correct. The article just quotes a sentence from each of the summary judgement motions and then observes, as you do, that "the bulk of the arguments" of each side are under seal and that neither company responded to a request for comment.

I don't but pretty much everything is sealed so I am not sure how much info this article could possibly have:

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

ENTA did seem to score a small victory proving most (but not all) of certain documents that PFE was hoping to get unsealed are in fact privileged. This is from early May:

https://casetext.com/case/enanta-pharm-v-pfizer-inc-2

On the present record before the Court, therefore, Enanta has not met its burden to prove that the redacted information is privileged. Nevertheless, this Court will give Enanta an opportunity to do so. Within two weeks, Enanta shall file declaration(s) supporting its assertions

Enanta was given time to support the redaction which was granted yesterday on most counts:

order Order Wed 05/29 1:09 PM
Magistrate Judge Jennifer C. Boal: ELECTRONIC ORDER entered. On May 7, 2024, this Court issued an order on Pfizer's Motion to Compel Production of Documents Improperly Withheld as Privileged (Docket No. 160 ). See Docket No. 247 . This Court ordered Enanta to submit declarations supporting its assertions of privilege with respect to Exhibits B, F (slide 2), L, O, R, and S. On May 21, 2024, Enanta submitted declarations supporting its assertion of privilege with respect to Exhibits B, F (slide 2), L (emails dated April 7, 2020, 3:16 PM, and April 7, 2020, 4:14 PM), R, and S and it withdrew its privilege assertions with respect to Exhibit O and Exhibit L (email dated April 7, 2020, 8:32 PM). After review and consideration of Enanta's submissions, this Court finds that the redactions to Exhibits B, F (slide 2), L (emails dated April 7, 2020, 3:16 PM, and April 7, 2020, 4:14 PM), R, and S are privileged. (Hutchins, Aaron)

Anyone have access to this full article dated May 29, 2024?

Pfizer, Enanta Launch Dueling Bids to Gut Paxlovid Patent Case

https://news.bloomberglaw.com/health-law-and-business/pfizer-enanta-launch-dueling-bids-to-gut-paxlovid-patent-case

So far, all of the patent filings have benefitted the legal team that wrote and submitted them.

Do these patents really matter? (Contrary to my earlier post! )

Saturated spirocyclics as antiviral agents
Patent number: 11993600
Abstract: The present invention discloses compounds of Formula (I), and pharmaceutically acceptable salts, thereof: which inhibit coronavirus replication activity. The invention further relates to pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and methods of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
Type: Grant
Filed: December 6, 2022
Date of Patent: May 28, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Joseph D. Panarese, Samuel Bartlett, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

Enanta Pharmaceuticals to Participate at the Jefferies Global Healthcare Conference
May 29, 2024

WATERTOWN, Mass.--(BUSINESS WIRE)--May 29, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, and Tara L. Kieffer, Ph.D., Chief Product Strategy Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2024 at 7:30 a.m. ET in New York, NY.

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-participate-jefferies-global-healthcare-0

FWIW - Good news for a potential buyer?

Enanta Pharmaceuticals sees highest patent filings and grants during February in Q1 2024

Excerpts:
Enanta Pharmaceuticals saw the highest growth of 199% in patent filings in February and 499% in grants in January in Q1 2024. Compared to Q4 2023, Q1 2024 saw an increase in patent filings by 24% and grants by 499%.

Patents related to rare diseases and Covid-19 lead Enanta Pharmaceuticals's portfolio
Enanta Pharmaceuticals has the highest number of patents in rare diseases followed by, Covid-19 and climate change. For rare diseases, nearly 50% of patents were filed and 38% of patents were granted in Q1 2024.

Respiratory syncytial virus (rsv) infections related patents lead Enanta Pharmaceuticals portfolio followed by cardiovascular disease, and fatty liver disease
Enanta Pharmaceuticals has highest number of patents in respiratory syncytial virus (rsv) infections followed by cardiovascular disease, fatty liver disease, non alcoholic fatty liver disease (nafld), and non-alcoholic steatohepatitis (nash).

Read more:
https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-patent-activity/?cf-view

Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024.Is that a typo that should be May 31?

Thanks.
I just saw this amd thought there may be a counter suit.


Counter Claimant
Pfizer Inc.
Represented By
Thomas H.L. Selby
Williams & Connolly, LLP
contact info
Lee C. Bromberg
Mccarter & English, LLP
contact info
David I. Berl
Williams & Connolly, LLP
contact info
Wyley S. Proctor
Mccarter & English, LLP
contact info
Julie Tavares
Williams & Connolly LLP
contact info
Christopher Yeager
Williams & Connolly LLP
contact info
Erik Paul Belt
Mccarter & English, LLP
contact info
Counter Defendant
Enanta Pharmaceuticals, Inc.
Represented By
Donald R. Ware
Foley Hoag LLP
contact info
Barbara A. Fiacco
Foley Hoag LLP
contact info
Defendant
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Represented By
Thomas H.L. Selby


https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Clown finger is double clicking and iHub is taking it literally by posting my message twice.

I have not heard of any countersuit. It looks to me like the schedule of events I relayed on September 1, 2023 has been fulfilled:

Deadline for completion of expert depositions by April 12, 2024. Deadline for summary judgment motions and Daubert motions May 10, 2024. Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024. Deadline to file replies in support of summary judgment motions and replies in support of Daubert motions June 14, 2024

Are there any clowns anywhere?

Yes I think we know if the suit has enough merit to go to trial before summers end

Re Lawsuit
Looks like there are several motions in connection with summary judgement in the PFE case.

Hard to discern who has the upper hand from a motion being filed.

Luly said in the past a trial was expected by end of this year, but on the last earnings call said IF a trial happens will likely be later this year. Sounds to me a decent chance the suit gets thrown out (and there seems to be a countersuit against enta but i could be reading this wrong). However if the suit proceeds to trial then I would expect PFE to come to the negotiating table.

It looks to me as if things are coming to a head.

Re Lawsuit
Looks like there are several motions in connection with summary judgement in the PFE case. Luly said in the past a trial was expected by end of this year, but on the last earnings call said IF a trial happens will likely be later this year. Sounds to me a decent chance the suit gets thrown out (and there seems to be a countersuit against enta but i could be reading this wrong). However if the suit proceeds to trial then I would expect PFE to come to the negotiating table.
JMO
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

re RSV polymerase inhibitor (EDP-323)

you want to stay a step ahead of competition.

Shionogi has an RSV polymerase inhibitor in a challenge study. There is also some color on ensitrelvir and the recent readout that missed the primary endpoint in the shionogi transcript for those interested

https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2023/4q/e20240516.pdf

ah got it - they only mentioned the 28M bc they had to record interest earned on that money for accounting purposes
32M is nothing to sneeze at for a company their size

There a $28M tax refund that ha been due for some time and a new $4M refund due.

The company mentions a 28M income tax refund on calls but in the filing it says 32M. It’s a small discrepancy but what am I missing?

ENTA’s fully-diluted share count @3/31/24=27.04M—essentially unchanged since 12/31/23.

The 27.1M figure above consists of: 21.18 basic shares on the 3/31/24 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017024055581/enta-20240331.htm ); and 5.86M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, page 9).

ENTA’s pro forma net cash @3/31/24=$148.6M—treating ENTA’s deferred-royalty obligations as debt, as is done under GAAP [#msg-172603887]—but see note at bottom of this post. The $148.5M figure, which is down $27.7M relative to 12/31/23, consists of:

• $296.4M net current assets on the 3/31/24 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017024055581/enta-20240331.htm );

• ($147.8M) deferred long-term liabilities on the 12/31/23 balance sheet relating to the OMERS royalty agreement. ($33.7M of liabilities relating to the OMERS agreement are booked as current liabilities and hence are included in the $296.4M figure in the first bulleted item.)

Note: Excluding the “debt” associated with the OMERS royalty agreement, ENTA’s pro forma net cash at 3/31/24 was $330.1M ($148.6M + $147.8M + $33.7M).

I think the panoramic trial is powered that they should be able to show efficacy on outcomes like hospitalization even with event rates much lower now in a more immune experienced population
If I were a pharma I would want to see the ensitrelvir data and then decide on 235 bc at this point you are talking only a few months (NIH is running the study so it’s not going to be suppressed long like epic-Sr
NIH of course could choose to fund 235 too if the data do suggest it might be better on efficacy than ensitrelvir

Paxlovid - dewqophile and vinmantoo, I strongly suspect you both know this, but in the Paxlovid EPIC-SR trial reported in NEJM in April, Paxlovid flopped completely on syptom relief. https://www.nejm.org/doi/full/10.1056/NEJMoa2309003

Mouton, Thanks for bringing that up. Yes I remember that Paxlovid failure of symptom relief but it is worth repeating now. It failure in symptom relief in all groups, including high risk and standard risk patients regardless of vaccine status. Together with Shinogi's Ensitrelvir failure it would seem to provide an opening for EDP-235. Paxlovid was approved early in the pandemic based on it's ability to reduce hospitalization and death. The general population is now highly immune so the thankfully, death and hospitalization are much lower. That makes symptom relief the major endpoint the FDA should be concerned with. Whether they will insist on all 15 symptoms of a key subset is the big question as dewophile has pointed out.

The huge Panoramic trial in the UK has finally stopped enrolling and will follow patients till September. https://www.panoramictrial.org/ Presumably results will be reported not too long after that, but who knows, they do seem to be taking their time. That's a randomized trial of Paxlovid v. standard of care in a vaccinated population. If Paxlovid doesn't show a benefit (either in symptom relief or reducing hospitalization/death), will that change anyone's mind about using it?

That is the key question once that trial data comes in. Again, a Paxlovid partial failure may provide a small opening for EDP-235 but ENTA needs a money bags to fund the trial. Another question is if ENTA wins their lawsuit against PFE for patent infringement by Paxlovid and gets a decent cash settlement and a percentage of future sales, will ENTA consider funding the trial themselves? If so, will PFE decide it is worth it to buy ENTA rather than pay a percentage of future sales?

Interestingly Shionogi DID see efficacy on the 14 symptom scale in Asia so they are different patient populations when it comes to immunity
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10858401/#note-ZOI231613-1-s
see table 2 14 symptom scale met stat sig

Thanks for the link. Funny thing is the 12 symptom scale didn't reach significance but the lower (125mg) dose did for the 14 symptom scale. The higher dose (250mg) was on the border of significance. If I am not mistaken, the improvement was 1 day.

Sounds like a wonderful trip!

Yes it was. The pool was great but my sunscreen application needs some work as I missed a bit on my lower legs so there was a little burn. I am going back late September to see if my sunscreen application improves.

Hi Mouton - yes I was aware the EPIC-SR results were finally published (failure of the trial as you know was publicized nearly 2 years prior). I alluded to this in my post listing paxlovid as one of the drugs that failed to show a difference in sustained resolution of the 15 symptom endpoints. Japanese regulators allowed Shionogi to focus on fewer endpoints that were more common especially with current variants for approval.
As I said to Vin it could be when data from the SORPIO-HR trial (ensitrelvir) is made public (hopefully it won't be after a 2 year lag like the PFE trial) a cross trial comparison can be made to gauge EDP-235 relative to ensitrelvir on symptom endpoint.

Paxlovid - dewqophile and vinmantoo, I strongly suspect you both know this, but in the Paxlovid EPIC-SR trial reported in NEJM in April, Paxlovid flopped completely on syptom relief. https://www.nejm.org/doi/full/10.1056/NEJMoa2309003

Notwithstanding the "SR" or "standard risk" title, the trial did enroll a significant number of high risk patients if they had been vaccinated. And even in that subgroup, symptoms were not resolved materially sooner:

EFFICACY
The primary objective of the trial was to compare the efficacy of nirmatrelvir–ritonavir with that of placebo for the treatment of Covid-19, as measured by the difference in time to sustained alleviation of all targeted Covid-19 signs and symptoms through day 28. All efficacy end points were evaluated in the population of participants who took at least one dose of nirmatrelvir–ritonavir or placebo and had at least one postbaseline visit. The targeted symptoms were cough, shortness of breath or difficulty breathing, feeling feverish, chills or shivering, muscle or body aches, diarrhea, nausea, vomiting, headache, sore throat, and stuffy or runny nose. Participants recorded daily symptom severity on a 4-point scale (0, absent; 1, mild; 2, moderate; 3, severe). Sustained alleviation was considered to have occurred on the first of 4 consecutive days during which all symptoms that had been scored as moderate or severe and as mild or absent at baseline were scored as mild or absent and as absent, respectively. ...

EFFICACY
Among the 1288 participants who received at least one dose of nirmatrelvir–ritonavir or placebo and had at least one postbaseline visit, the median time to sustained alleviation of all targeted Covid-19 signs or symptoms through day 28 was 12 days in the nirmatrelvir–ritonavir group and 13 days in the placebo group, a difference that was not significant (P=0.60) (Table 2). Similar results were observed in the high-risk subgroup (i.e., participants who had been vaccinated and had at least one risk factor for severe illness) and in the standard-risk subgroup (i.e., those who had no risk factors for severe illness and had never been vaccinated or had not been vaccinated within the previous 12 months).


The huge Panoramic trial in the UK has finally stopped enrolling and will follow patients till September. https://www.panoramictrial.org/ Presumably results will be reported not too long after that, but who knows, they do seem to be taking their time. That's a randomized trial of Paxlovid v. standard of care in a vaccinated population. If Paxlovid doesn't show a benefit (either in symptom relief or reducing hospitalization/death), will that change anyone's mind about using it?

Sounds like a wonderful trip!
I think the endpoint is resolution of symptoms for one day, and we don't know the difference between placebo and treatment yet
Somewhat agree about virology - the differences could be due to pt populations (notably 30% were high risk vs essentially none in SPRINT), but we just don't know yet without the data. This is more supportive anyway - remdesivir for example was approved without showing any virology effects IIRC
Interestingly Shionogi DID see efficacy on the 14 symptom scale in Asia so they are different patient populations when it comes to immunity
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10858401/#note-ZOI231613-1-s
see table 2 14 symptom scale met stat sig
I don't know if the FDA will be more flexible in light of all these recent failures (add oral remdesivir to the list, paxlovid in standard risk, etc), but usign the 15 symmptom endpoint in a very immune population like we have now is a high bar and I don't know if someone really thinks 235 can clear it - they were 2 days on the 6 most common symptom scale but only a trend I think on the 14 but I don't really recall that data and it was from a smaller study
I think once the actual data are out from scorpio-HR you can try and make some cross trial comparisons

FDA is torpedoing next gen drugs with this strict 15 symptom primary. Japan approved using the most common handful of symptoms which I feel is a very reasonable endpoint (and more in line w flu which required 7 endpoints)
Perhaps the FDA will come around otherwise I’m not sure we are going to get anything other than paxlovid for Covid (and 235 IS an advance when it comes to DDIs but it doesn’t seem like anyone wants to touch it with the 15 symptom endpoint )
I still think this is bullish for enta by dint of a possible stake in paxlovid but the market doesn’t seem to agree

I think it could be bullish for ENTA on both fronts. The failure of Ensitrelvir does indeed solidify Paxlovid's position, and if ENTA wins their lawsuit that could certainly benefit ENTA shareholders more. Still a big if but it remains a possibility. As far as whether Ensitrelvir's failure will more directly benefit EDP-235 and ENTA's prospects, my gut feeling is we might see a slow rise over time as the news Ensitrelvir's failure gets digested. That is not exactly an unbiased view, but take it for what it is worth.