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.

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The drug met both its primary and secondary efficacy endpoints, achieving noninferiority 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.

Nuzrya is currently marketed in the US and China for the treatment of adults with CABP and acute bacterial skin and skin structure infections (ABSSSIs).

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This antibiotic is effective against a broad spectrum of bacteria, and it can evade various resistance mechanisms.

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Paratek Pharmaceuticals reported that Nuzyra demonstrated an early clinical response rate of 89.6%, compared to 87.7% 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% of patients within the intent-to-treat population and 94.1% of patients in the clinically evaluable population demonstrated clinical success with the use of Nuzyra.

This was compared to 87.7% of patients and 95.9% of patients with the use of moxifloxacin, respectively.

Nuzyra met all US Food and Drug Administration (FDA)-specified primary and secondary endpoints, achieving noninferiority versus moxifloxacin.

Additionally, Nuzyra was found to be safe and well-tolerated, with 2.7% of drug-related treatment-emergent adverse events (TEAEs) attributable to Nuzyra, compared to 6.9% for moxifloxacin.

The overall rates of TEAEs were 27.7% for omadacycline and 23.5% for moxifloxacin, with the most commonly observed TEAEs being headache (3.6% versus 4.5%), Covid-19 (3.3% versus 1.2%), and aspartate aminotransferase increase (2.1% versus 0.0%).

Both treatment groups exhibited the same discontinuation rate (2.7%) and the same overall mortality rate (1.8%).

The results of this Phase III post-marketing commitment study demonstrate the drug’s continued clinical success and are consistent with the results of the pivotal Phase III study, which supported the approval of Nuzyra by the FDA in 2018.

These two studies (OPTIC and OPTIC-2) have amounted to the largest clinical data set in pneumonia for any antibiotic approved in the last decade.

In addition to CABP and ABSSSIs, Nuzyra is in development for the treatment of other bacterial infections, including nontuberculous mycobacterial pulmonary disease (NTM-PD).

Key opinion leaders (KOLs) interviewed by leading data and analytics company 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 mycobacterium avium complex.

According to GlobalData’s estimates, Nuzyra is expected to launch for the treatment of NTM-PD in the US in 2029 and in the EU in 2030.

Furthermore, high-prescribing physicians surveyed by GlobalData in June 2024 expect that approximately 25% 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.