Paratek Pharma Announces Positive Top-Line Data from Phase 2b Study of Oral Omadacycline

Paratek Pharma Announces Positive Top-Line Data from Phase 2b Study of Oral Omadacycline

By, Admin 12 November 2024

Paratek Pharma announces positive top-line data from phase 2b study of oral omadacycline in NTM abscessus pulmonary disease

Overview

Paratek Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for serious diseases, announced top-line results from its phase 2b study of oral omadacycline in adult patients with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc).

Statement from Principal Investigator

  • The results from this first-ever placebo-controlled trial in MABc patients are exciting and support the idea that omadacycline has clinical utility in this very challenging disease setting. Omadacycline treatment demonstrated positive results across multiple clinical and microbiological endpoints in the study,"" said Kevin Winthrop, M.D., M.P.H., Center for Infectious Disease Studies, at Oregon Health and Science University and Principal Investigator in the study, 
  • The results suggest its potential to become an important addition to the very limited treatment options currently available for patients with Mycobacterium abscessus, providing hope for improved patient outcomes. This is something that clinicians and patients in the NTM community should be very encouraged by.""

About the Trial

  • The phase 2b double-blind, placebo-controlled, randomized study evaluated the safety, efficacy, and tolerability of omadacycline in patients with Mycobacterium abscessus pulmonary disease. 
  • Sixty-six patients were randomized 1.5:1 to treatment with omadacycline (n= 41) or placebo (n=25) for 84 days, followed by a 30-day safety follow-up period.
  • While the study was not designed to formally test for statistical differences between treatment arms, a trend favouring omadacycline was consistently observed across top line primary and secondary endpoints. 
  • The primary efficacy endpoint was the response on the NTM Symptom Assessment Scale at Day 84 and was evaluated 2 different ways. 
  • The first (Evaluation 1) defined a positive response as an improvement in at least 50% of the NTM symptoms present at baseline. 
  • The second (Evaluation 2) was a more stringent approach, requiring improvement in at least 50% of the NTM symptoms present at baseline AND no worsening of any baseline symptom.

Outcomes for Omadacycline Treated Patients

  • Omadacycline-treated subjects demonstrated a favourable trend towards higher response rates compared with placebo-treated subjects for both Evaluation 1 (34.1% vs 20%; p = 0.218) and Evaluation 2 (34.1% vs 12%; p = 0.046). 
  • The Quality of Life-Bronchiectasis (QOL-B), a patient-reported outcomes measure, favoured omadacycline across all domains, particularly in vitality, physical functioning, social functioning, and respiratory symptoms. 
  • In addition, both patient and clinician assessments of clinical status improved over time in the omadacycline-treated group, while the placebo group showed worsening or no change. 
  • On microbiological endpoints, omadacycline-treated patients had a higher rate of negative sputum cultures for MABc (56.4% vs 29.2%, p=0.035) and a greater reduction in semi-quantitative sputum culture scores (76.5% vs 45.8%, p=0.017) at day 84 compared to placebo.

Safety Profile of Oral Omadacycline

  • Oral omadacycline administered for up to 12 weeks was generally safe and well-tolerated. 
  • The safety profile was consistent with the established profile for Nuzyra (omadacycline), and no new safety signals were observed over this treatment period. 
  • The most common treatment-emergent adverse events were gastrointestinal symptoms. No deaths occurred in the study. 
  • Two subjects in the placebo-group experienced serious adverse events. 
  • Treatment discontinuation due to adverse events occurred in four (9.8%) omadacycline-treated patients.

Words from the CEO: Paratek Pharmaceuticals

  • These findings add to a growing dataset that supports the potential for symptomatic and microbiological improvement with omadacycline for those patients struggling with MABc pulmonary disease."" said Evan Loh, M.D., chief executive officer of Paratek Pharmaceuticals. 
  • his community needs better treatment options. I want to thank the patients, caregivers, and investigators who participated and made this encouraging outcome possible.
  • Analysis of all study data is ongoing and the complete data from this study will be presented in the future and published in a peer-reviewed journal.

About Nuzyra (omadacycline)

  • Nuzyra (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. 
  • A next generation tetracycline, Nuzyra is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical and other drug-resistant strains.

About the company: Paratek Pharmaceuticals

Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative treatments for life-threatening diseases and other public health threats.