Phase III post-marketing commitment study data paves way for usage of Paratek’s Nuzyra in other indications: GlobalData

Paratek Pharmaceuticals has announced positive topline efficacy and safety data from a global, Phase III post-marketing commitment study of its novel antibiotic, a next-generation tetracycline, Nuzyra (omadacycline). In a study of 670 adults with moderate to severe community-acquired bacterial pneumonia (CABP), Nuzyra was found to be generally safe and well-tolerated. The drug met both primary and secondary efficacy endpoints, achieving non-inferiority relative to the comparator drug, moxifloxacin. This positive Phase III data demonstrates the continued clinical success of Nuzyra and lays the foundation for expanded usage of the drug in other indications, says GlobalData.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, states, “Nuzyra is currently marketed in the US and China for the treatment of adults with CABP and acute bacterial skin and skin structure infections (ABSSSI). This antibiotic is effective against a broad spectrum of bacteria, and it can evade various resistance mechanisms.”

Paratek Pharmaceuticals reported that Nuzyra demonstrated an early clinical response (ECR) rate of 89.6 per cent, compared to 87.7 per cent for moxifloxacin, 72-120 hours after the initiation of therapy. In the post-treatment evaluation, 5-10 days after the completion of therapy, 86.0 per cent of patients within the intent-to-treat population and 94.1 per cent of patients in the clinically evaluable population demonstrated clinical success with the use of Nuzyra. This was compared to 87.7 per cent and 95.9 per cent for moxifloxacin, respectively.

Nuzyra met all FDA-specified primary and secondary endpoints, achieving noninferiority versus moxifloxacin. Additionally, Nuzyra was found to be safe and well-tolerated, with 2.7 per cent of drug-related treatment emergent adverse events (TEAEs) attributable to Nuzyra, compared to 6.9 per cent for moxifloxacin.

“The results of this Phase III post-marketing commitment study are consistent with those of the pivotal Phase III study, which supported the approval of Nuzyra by the FDA in 2018 and demonstrate the drug’s continued clinical success. In addition to CABP and ABSSSI, Nuzyra is in development for the treatment of other bacterial infections, including nontuberculous mycobacterial pulmonary disease (NTM-PD),” adds Kurdach.

Key opinion leaders (KOLs) interviewed by GlobalData have expressed positive opinions on the development of Nuzyra for NTM-PD, particularly because this indication lacks novel, effective therapeutics. Several US KOLs have acknowledged that they utilise Nuzyra off-label for the treatment of NTM-PD caused by the species Mycobacterium abscessus and M. avium complex (MAC).

According to GlobalData estimates, Nuzyra for the treatment of NTM-PD is expected to launch in the US in 2029 and in the EU in 2030. Further, high-prescribing physicians surveyed by GlobalData in June 2024 expect that approximately one quarter of NTM patients will be treated with Nuzyra by 2033.

“The clinical success of Paratek’s Nuzyra has the potential to translate into increased patient shares and increased market share across numerous infectious disease indications,” concludes Kurdach.