Safety and Antiviral Activity of Assembly Biosciences’ First and Second Generation Core Inhibitor Candidates In the Treatme...
October 16 2019 - 7:05AM
Assembly Biosciences, Inc. (NASDAQ: ASMB), a clinical-stage
biotechnology company developing innovative therapeutics targeting
hepatitis B virus (HBV) and diseases associated with the
microbiome, today announced that data on its lead HBV core
inhibitor candidates, ABI-H0731 (731) and ABI-H2158 (2158) for the
treatment of chronic HBV will be featured in a late-breaking poster
session during the American Association for the Study of Liver
Diseases (AASLD) Annual Meeting (The Liver Meeting®), November
8-12, 2019, in Boston.
“We are pleased to have data from our two lead core inhibitor
programs featured at the AASLD Annual Meeting, the premier
conference in the U.S. for Hepatitis B and other liver diseases,
and that our abstracts were selected for late-breaking posters,”
said John McHutchison, AO, MD, Chief Executive Officer and
President. “We are very encouraged that the final Phase 2a data
indicate that the addition of 731 to nucleos(t)ide therapy not only
produces faster and deeper declines in HBV DNA and pgRNA for
patients, but also subsequent declines in the surrogate markers
predictive of cccDNA pool depletion. These data combined with a
favorable safety and tolerability profile following long-term
treatment indicate the potential for our core inhibitor regimens on
the path to HBV cure. We continue to advance our clinical
portfolio of core inhibitors with interim data from the Phase 1b
trial of 2158, our second generation candidate, demonstrating
potent antiviral activity as a monotherapy over 14 days of
treatment.”
ABI-H0731
LP-1Title: Continued Therapy with
ABI-H0731+Nrtl Results in Sequential Reduction/Loss of HBV DNA, HBV
RNA, HBeAg, HBcrAg and HBsAg in HBeAg-Positive Patients
Session: Late-breaking Poster Session
Location: Hall BDate: Monday,
November 11, 2019 Time: 8:00am ET-5:30pm ET;
Poster presentation: 12:30pm ET-1:30pm ET
Presenter: Mark Sulkowski, MD, Medical Director,
Viral Hepatitis Center, Johns Hopkins University School of
MedicineAbstract Summary: Final results from
Phase 2a are reported for HBeAg+ patients with chronic HBV
infection treated with 731+Nrtl for 24 weeks. In Study 202 (Rx
naïve patients), greater mean log10 declines in HBV DNA (5.27 vs
3.99; p=0.017) and RNA (2.34 vs 0.61; p<0.001) were achieved
with 731+Nrtl (entecavir) versus entecavir alone. In Study 201
(Nrtl-suppressed patients), the proportion of patients on 731+Nrtl
versus Nrtl alone achieving DNA target not detected (TND) was 69%
vs 0% (p<0.001), and the proportion of patients achieving RNA
<35 U/mL whose RNA was ≥35 U/mL at baseline was 52% vs 0%
(p=0.0013) respectively. In Study 211, there are 64 HBeAg+ patients
currently on extended treatment beyond 24 weeks. Among the 27
HBeAg+ patients receiving 731+Nrtl in Study 201, 41% (11/27) have
now achieved DNA TND along with RNA <35 U/mL and HBeAg <1
IU/mL. At their last timepoint, Study 202 patients now in Study 211
(n=22) have demonstrated mean DNA and RNA declines of 6.1 and 3.0
logs, respectively, with observed mean log changes of ≥0.6 for
HBeAg (11 patients ≥0.5, 4 patients ≥1.0), >0.8 log for HBcrAg
(7 patients ≥1.0, 3 patients ≥2.0) and ≥0.4 log for HBsAg (7
patients ≥0.5, 3 patients ≥1.0). 731 continues to exhibit a
favorable safety and tolerability profile in patients treated for
up to 1 year, with only mild/moderate adverse events and lab
abnormalities, and only a single discontinuation due to a Grade 1
rash. The combination of 731+NrtI results in faster and deeper
declines in HBV DNA and RNA than NrtI alone, as well as subsequent
declines in the surrogate markers of cccDNA (pgRNA, HBeAg and
HBcrAg) predictive of cccDNA pool depletion, and HBsAg. The
emergent data supports the continued development of 731.
Abstract data are as of the time of submission; the poster is
expected to include updated safety and efficacy results.
ABI-H2158
LP-14Title: The Second-Generation
Hepatitis B Virus (HBV) Core Inhibitor (CI) ABI-H2158 is Associated
with Potent Antiviral Activity in a 14-Day Monotherapy Study in
HBeAg-positive Patients with Chronic Hepatitis B (CHB)
Session: Late-breaking Poster
SessionLocation: Hall BDate:
Monday, November 11, 2019Time: 8:00am-5:30pm ET;
Poster presentation: 12:30pm-1:30pm ETPresenter:
MF Yuen, MD, PhD, Chief of Division of Gastroenterology and
Hepatology, Queen Mary Hospital, Hong Kong Abstract
Summary: The Phase 1b study is enrolling sequential
cohorts of 9 patients and each cohort will be randomized to receive
2158 or placebo (7:2) QD for 14 days in a blinded manner. Dosing in
the 1st cohort (100 mg) has been completed. In patients receiving
2158, mean declines from Baseline to Day 15 in HBV DNA and RNA
levels were 2.3 log10 IU/mL [range 1.7 – 3.0] and 2.1 log10 IU/mL
[range 1.5 - 2.7] respectively. No serious AEs, dose limiting
toxicities or premature discontinuations were reported. Three
patients reported a total of 5 mild, drug-related AEs that
recovered without intervention; dizziness, fatigue, rash, headache
and upper abdominal pain. Treatment emergent laboratory
abnormalities were infrequent, mild and transient, with no ALT
elevations Grade ≥1 in severity. Day 14 plasma 2158 Cmax and
AUC0-24hr were 3,390 ng/mL and 46,100 hr*ng/mL, respectively.
Results from the initial 100 mg low dose of ABI-H2158 cohort
demonstrated potent antiviral activity, a favourable safety profile
when administered for 14 days, and support once daily dosing in CHB
patients. Abstract data are as of the time of submission; the
poster may include data from additional cohorts if available at the
time of the conference.
These posters will be made available on the Events &
Presentations page in the Investors section of the company’s
website at assemblybio.com after the scheduled poster session has
begun.
Conference Call and Webcast Information
Assembly will host a live conference call and audio webcast on
Monday, November 11, 2019, at 8:30 am ET. Details for the
conference call will be provided at a later date.
About Assembly BiosciencesAssembly Biosciences,
Inc. is a clinical-stage biotechnology company developing
innovative therapeutics targeting hepatitis B virus (HBV) and
diseases associated with the microbiome. The HBV program is focused
on advancing a new class of potent, oral core inhibitors that have
the potential to increase cure rates for chronically infected
patients. The microbiome program is developing novel oral live
microbial biotherapeutic candidates with Assembly’s fully
integrated platform, including a robust process for strain
identification and selection, GMP banking and production, and
targeted delivery to the lower gastrointestinal tract with the
GEMICEL® technology. For more information, visit
assemblybio.com.
Forward-Looking StatementsThe information in
this press release contains forward-looking statements regarding
future events, including statements about the clinical and
therapeutic potential of core inhibitors, including ABI-H0731 and
ABI-H2158, the timing of reporting data and the results of clinical
studies being predictive of results in future clinical studies.
Certain forward-looking statements may be identified by reference
to a future period or by use of forward-looking terminology such as
“anticipated,” “expects,” “may” “suggest,” “will” and “potential.”
Assembly intends such forward-looking statements to be covered by
the safe harbor provisions contained in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. More information about the
risks and uncertainties faced by Assembly are more fully detailed
under the heading “Risk Factors” in Assembly's Quarterly Report on
Form 10-Q for the quarter ended June 30, 2019 filed with
the Securities and Exchange Commission. Except as required by
law, Assembly assumes no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
ContactsAssembly Biosciences,
Inc.Investors:Lauren Glaser(415)
521-3828lglaser@assemblybio.com
Assembly Biosciences (NASDAQ:ASMB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Assembly Biosciences (NASDAQ:ASMB)
Historical Stock Chart
From Sep 2023 to Sep 2024