Paratek Pharmaceuticals has announced positive top-line safety, efficacy, and tolerability data from a Phase IIb study of oral omadacycline. In a study of 66 adult patients with nontuberculous mycobacteria pulmonary disease (NTM-PD) caused by mycobacterium abscessus complex (MABc), oral omadacycline was found to be generally safe and well-tolerated, in addition to demonstrating higher response rates compared to a placebo. This first-ever, randomised, placebo-controlled trial among MABc patients highlights omadacycline’s potential to fulfil a critical unmet need within the NTM market.
Paratek’s omadacycline is already marketed in the US and China for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, under the brand name Nuzyra. Omadacycline is currently in the development pipeline for several other indications, including NTM-PD, in which it has fast-track designation from the US Food and Drug Administration (FDA) and orphan drug designation from both the FDA and European Medicines Agency.
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Paratek Pharmaceuticals reported the primary efficacy endpoint as the response on the NTM Symptom Assessment Scale at day 84. Of the patients administered omadacycline, 34.1% saw an improvement in at least 50% of their NTM symptoms present at baseline. Further, 34.1% of patients saw an improvement in at least 50% of their NTM symptoms present at baseline and did not experience any worsening of any baseline symptom. This was compared to 20% and 12% of patients administered a placebo, respectively. Also, Paratek Pharmaceuticals reported that 56.4% of patients administered omadacycline had negative sputum cultures for MABc at day 84, compared to 29.2% of placebo patients.
Oral omadacycline reported a safety profile consistent with that of the established profile for Nuzyra. The most common adverse events were gastrointestinal symptoms. Four patients (9.8%) who had been administered omadacycline discontinued treatment due to adverse events. No deaths were reported in this study.
The results of this Phase IIb study highlight omadacycline’s potential within the NTM market. The majority of the drugs currently used to treat NTM infections are used off-label, which leaves a critical unmet need for new therapeutic options with improved efficacy, specifically approved for the use of NTM infections.
Key opinion leaders (KOLs) interviewed by leading data and analytics company GlobalData have expressed positive opinions on the development of oral omadacycline for NTM-PD, particularly because this indication lacks novel, effective therapies. Several US KOLs have acknowledged that they utilise omadacycline off-label for the treatment of NTM-PD caused by MABc and M. avium complex.
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By GlobalDataAccording to GlobalData estimates, oral omadacycline for the treatment of NTM-PD is expected to launch in the US in 2029 and in the EU in 2030. Furthermore, high-prescribing physicians from the US surveyed by GlobalData in June 2024 expect that approximately one-quarter of NTM patients will be treated with omadacycline by 2033.
The clinical success of omadacycline highlights its potential to fulfil a critical unmet need within the NTM market, and possibly contribute to increased treatment success rates among NTM-PD patients.
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Paratek Pharmaceuticals Inc