Paratek's Nuzyra Set For Expansion With Promising Phase III Study Results

Paratek Pharmaceuticals has revealed promising results from a global Phase III study evaluating their novel antibiotic, Nuzyra (omadacycline). The study, involving 670 adults with moderate to severe community-acquired bacterial pneumonia (CABP), showed that Nuzyra is generally safe and well-tolerated. It achieved its primary and secondary efficacy goals, demonstrating non-inferiority to moxifloxacin. According to GlobalData, this successful Phase III outcome underscores Nuzyra's clinical effectiveness and paves the way for its broader application in additional indications.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, said that, “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 announced that Nuzyra showed an early clinical response (ECR) rate of 89.6% compared to 87.7% for moxifloxacin, measured 72-120 hours after starting treatment. During the post-treatment evaluation, conducted 5-10 days after therapy completion, 86.0% of patients in the intent-to-treat population and 94.1% of those in the clinically evaluable population achieved clinical success with Nuzyra. This compared to 87.7% and 95.9% for moxifloxacin, respectively.

Nuzyra successfully met all FDA-specified primary and secondary endpoints, proving noninferiority to moxifloxacin. Additionally, Nuzyra was found to be generally safe and well-tolerated, with 2.7% of patients experiencing drug-related treatment emergent adverse events (TEAEs) compared to 6.9% for moxifloxacin.

Kurdach said that, “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).”

Key opinion leaders (KOLs) interviewed by GlobalData have shown enthusiasm for the development of Nuzyra as a treatment for NTM-PD, citing the current lack of effective therapies for this condition. Several KOLs in the US mentioned they already use Nuzyra off-label to treat NTM-PD caused by Mycobacterium abscessus and M. avium complex (MAC). GlobalData projects that Nuzyra will be approved for NTM-PD in the US by 2029 and in the EU by 2030. Additionally, a survey of high-prescribing physicians conducted by GlobalData in June 2024 predicts that by 2033, approximately 25% of NTM patients will be treated with Nuzyra.

Kurdach futher added, “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.”