Consistent Efficacy and Safety Profile Observed in New Analyses of OASIS-1 Phase 3 Study of Omadacycline in Patients with Dif...
October 06 2017 - 8:00AM
- No dosing adjustment anticipated in these
special populations
Paratek Pharmaceuticals (Nasdaq:PRTK) announced the results of
three sub-analyses from the Phase 3 OASIS-1 study that show a
consistent safety and efficacy profile of its once-daily oral and
intravenous (IV), broad-spectrum investigational antibiotic,
omadacycline, when treating Acute Bacterial Skin and Skin Structure
Infections (ABSSSI) in patients with comorbid conditions, which
could be associated with reduced treatment efficacy and increased
safety-related adverse events. These data will be presented
tomorrow, October 7, at IDWeek 2017 in San Diego.
The analyses compared omadacycline to linezolid in subsets of
ABSSSI patients enrolled in the global Phase 3 registration study
with: chronic kidney disease; high body mass index; diabetes, and a
history of intravenous drug users with or without hepatitis C
infection. In addition to omadacycline demonstrating a
consistent efficacy and safety profile compared to linezolid, these
data suggest that no dose adjustments for omadacycline are required
in patients with these comorbid conditions.
“These data demonstrate that dosing adjustments should not be
required for patients with comorbid conditions such as impaired
renal function, diabetes or a high body mass index, and support our
confidence that omadacycline has the potential to offer physicians
the convenience of a fixed-dose, well-tolerated, once-daily, oral
and IV antibiotic option in patients with community-acquired skin
infections,” said Evan Loh, M.D., President, Chief Operating
Officer, and Chief Medical Officer, Paratek. “As we look towards
FDA approval and commercialization, the ongoing analyses of our
clinical data continue to bolster our confidence in omadacycline’s
potential to address the significant health challenge of antibiotic
resistance, even in patients where their comorbid conditions can
make it more challenging to treat their infections.”
OASIS-1 (Omadacycline in Acute Skin Structure Infections Study)
evaluated the efficacy and safety of IV-to-oral once-daily
omadacycline against twice-daily linezolid over a 7 to 14-day
course of therapy in 645 treated patients. The primary efficacy
endpoint for the FDA was early clinical response (ECR) at
48 to 72 hours after the first dose of study drug in the modified
intent-to-treat (mITT) population (patients without a potentially
causative monomicrobial gram-negative infection). In the mITT
analysis population, omadacycline achieved the primary efficacy
endpoint of statistical non-inferiority (10% margin) compared to
linezolid. The ECR for the omadacycline and linezolid treatment
arms was 84.8% compared to 85.5%, respectively.
Additionally, the FDA-specified secondary endpoint was the
investigator assessment of response at the post treatment
evaluation (PTE) visit (7-14 days after the completion of therapy)
in both the mITT population (86.1% for omadacycline vs. 83.6% for
linezolid) and in the clinically evaluable (CE) population (96.3%
for omadacycline vs. 93.5% for linezolid).
- Omadacycline in Chronic Kidney Disease with
ABSSSI: In this safety analysis, 522 patients had stage
0/1 chronic kidney disease (CKD-0/1), 119 had stage 2/3 chronic
kidney disease (CKD-2/3). Response rates at ECR assessment were
slightly higher in patients with CKD-0/1 in the omadacycline group
(87.4%) compared to patients with CKD-2/3 (82.3%). Similarly, for
patients treated with linezolid, ECR rates were 87.1% and 83.7% for
CKD-0/1 and CKD-2/3, respectively.PTE responses in the mITT
population were 87.0% for omadacycline vs. 84.8% for linezolid in
CKD-0/1 patients. In patients with CKD-2/3, rates were 90.3% vs.
85.7% for omadacycline and linezolid, respectively. PTE responses
in the CE population were 96.7% for omadacycline vs. 94.4% for
linezolid in CKD-0/1 patients, and 94.7% for omadacycline vs. 91.1%
for linezolid in patients with CKD-2/3.Overall, omadacycline was
safe and generally well tolerated in patients with CKD, with
similar AEs to subjects without CKD. Overall, the safety and
efficacy of omadacycline in patients with CKD-0/1 and CKD-2/3 was
similar to that observed in the general population. TEAEs were
comparable between omadacycline and linezolid treatment.
- Omadacycline in Diabetic and Obese Patients with
ABSSSI: In the sub-analyses comparing omadacycline to
linezolid in patients with high BMI, evaluable patients had
elevated BMI of ≥25 (n=417). Of those, 225 were overweight (25 <
BMI <30) and 192 were obese (BMI > 30); irrespective of BMI,
59 patients had a medical history of diabetes.Omadacycline outcomes
were comparable at ECR assessments in patients with normal (BMI
<25) and high BMI. Outcomes in the high-BMI omadacycline
treatment group were comparable to outcomes in the linezolid
treatment group for the primary endpoint in the mITT (84.8% vs.
85.9%). At PTE, high BMI omadacycline-treated patients showed
higher clinical success than linezolid-treated patients (85.9% vs.
83.4%) in the mITT population. PTE response in the high BMI
CE population were 95.8% for omadacycline vs. 93.1% for
linezolid.At PTE, in both the mITT and CE populations,
omadacycline-treated diabetic patients showed higher clinical
success compared to linezolid-treated diabetic patients. Overall,
the safety and efficacy of omadacycline was consistent regardless
of BMI or diabetes diagnosis.
- Omadacycline in ABSSSI Patients with a History of IV
Drug Use (IVDU) and Hepatitis C (HCV+): In this analysis,
322 patients were IVDU and 168 were IVDU/HCV+. ECR rates were
comparable for both omadacycline and linezolid in both IVDU and
non-IVDU patients, regardless of HCV diagnosis. PTE responses with
omadacycline were higher than linezolid in non-IVDU patients in
both the mITT and clinically evaluable (CE) populations. For both
omadacycline and linezolid, clinical success at PTE tended to be
lower among IVDU and IVDU/HCV+ patients, compared with the non-IVDU
and non-IVDU/HCV- patients in the mITT populations. The lower
clinical success observed among IVDU and IVDU/HCV+ patients was due
to the greater number of indeterminate responses (e.g. lost to
follow-up, withdrew consent). Tolerability was similar across all
patient groups, with no major differences in liver function.
About Paratek Pharmaceuticals, Inc.Paratek
Pharmaceuticals, Inc. is a biopharmaceutical company focused
on the development and commercialization of innovative therapies
based upon its expertise in novel tetracycline chemistry. The
Company’s lead product candidate, omadacycline, is a new,
once-daily oral and intravenous broad-spectrum antibiotic being
developed for the treatment of serious community-acquired bacterial
infections, including community-acquired bacterial pneumonia
(CABP), acute bacterial skin and skin structure infections
(ABSSSI), and urinary tract infections. Omadacycline has
been granted Qualified Infectious Disease Product designation and
Fast Track status by the U.S. Food and Drug
Administration for the target indications of ABSSSI, CABP,
uUTI and cUTI. Paratek has completed Phase 3 development activities
for omadacycline in CABP and ABSSSI and is preparing to submit
marketing applications in the United States and European
Union. Paratek has licensed rights for omadacycline to Zai
Lab for the greater China region, and retains all
remaining global rights. Under a research agreement with
the U.S. Department of Defense, omadacycline also is being
studied against pathogenic agents causing infectious diseases of
public health and biodefense importance, including plague and
anthrax. Paratek's second Phase 3 product candidate, sarecycline,
is being developed by Allergan in the U.S. as a new
once-daily oral therapy for the treatment of acne. Allergan
has completed Phase 3 development activities for sarecycline and is
preparing a new drug application for submission to the U.S.
Food and Drug Administration. Paratek retains all ex-U.S. rights to
sarecycline. Recognizing the serious threat of bacterial
infections, Paratek is dedicated to providing solutions that enable
positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or follow
@ParatekPharma on Twitter.
Forward Looking StatementsThis press release
contains forward-looking statements including statements related to
our overall strategy, product candidates, clinical studies,
prospects, potential and expected results, including statements
about the timing of advancing omadacycline and otherwise preparing
for clinical studies, the timing of enrollment in our clinical
studies and our reporting of the results of such studies, the
potential for omadacycline to serve as an empiric monotherapy
treatment option for patients suffering from ABSSSI, CABP, UTI, and
other bacterial infections when resistance is of concern, the
prospect of omadacycline providing broad-spectrum activity, and our
ability to obtain regulatory approval of omadacycline All
statements, other than statements of historical facts, included in
this press release are forward-looking statements, and are
identified by words such as "advancing," "believe," "expect," "well
positioned," "look forward," "anticipated," "continued," and other
words and terms of similar meaning. These forward-looking
statements are based upon our current expectations and involve
substantial risks and uncertainties. We may not actually
achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in our forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Our actual results and the timing
of events could differ materially from those included in such
forward-looking statements as a result of these risks and
uncertainties. These and other risk factors are discussed
under "Risk Factors" and elsewhere in our Annual Report on Form
10-K for the year ended December 31, 2016, and our other
filings with the Securities and Exchange Commission. We
expressly disclaim any obligation or undertaking to update or
revise any forward-looking statements contained herein.
CONTACTS:
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Investor
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Michael Lampe |
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Hans Vitzthum |
(484) 575-5040 |
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LifeSci Advisors,
LLC. |
michael@scientpr.com |
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212-915-2568 |
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