Paratek Pharmaceuticals has released positive topline data from a Phase IIb trial evaluating its oral antibiotic omadacycline in adult patients with nontuberculous mycobacterial (NTM) pulmonary disease. This first-ever, randomised, placebo-controlled trial among Mycobacterium abscessus complex (MABc) patients, highlights omadacycline’s potential to fulfill a critical unmet need within the NTM market, says GlobalData
The placebo-controlled trial enrolled 66 patients with NTM pulmonary disease caused by MABc. In the study, oral omadacycline was found to be generally safe and well-tolerated, in addition to demonstrating higher response rates compared to a placebo.
Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments, “Omadacycline is already marketed in the US and China for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), under the brand name Nuzyra. It is currently in the development pipeline for several other indications, including NTM pulmonary disease (NTM-PD), in which it has Fast Track Designation and Orphan Drug Designation.”
Of the patients administered omadacycline, 34.1 per cent saw an improvement in at least 50 per cent of their NTM symptoms present at baseline. Further, 34.1 per cent of patients saw an improvement in at least 50 per cent of their NTM symptoms present at baseline and did not experience any worsening of any baseline symptom. This was compared to 20 per cent and 12 per cent of patients administered a placebo, respectively. Paratek Pharmaceuticals reported 56.4 per cent of patients administered omadacycline had negative sputum cultures for MABc at day 84, compared to 29.2 per cent of placebo patients.
Kurdach continues, “The results of this Phase IIb study highlight omadacycline’s potential within the NTM market. Most 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.”
The key opinion leaders (KOLs) interviewed by 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 (MAC).
According 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.
The 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.
Kurdach concludes, “The clinical success of omadacycline highlights its potential to fulfill a critical unmet need within the NTM market, and possibly contribute to increased treatment success rates among NTM-PD patients.”
Edits made by EP News Bureau