Paratek Pharmaceuticals, Inc has unveiled its results from a phase 3 clinical trial evaluating the effectiveness of omadacycline (Nuzyra), a once-daily oral and intravenous antibiotic, in the treatment of moderate to severe community-acquired bacterial pneumonia (CABP). In this study involving 670 patients at high risk for complications, omadacycline was compared to moxifloxacin, a standard treatment, highlighting its potential as a significant therapeutic option in addressing this serious respiratory condition.1
Randy Brenner, chief development, and regulatory officer at Paratek emphasized the significance of the findings in an exclusive conversation with Contagion, “The omadacycline clinical trial program for CABP now includes 1438 pneumonia patients which is the largest clinical dataset in pneumonia across all antibiotics approved by the FDA in the last decade. Two large, Phase 3 clinical trials have now demonstrated the efficacy of omadacycline in this disease with a safety profile that is consistent with the tetracycline class of antibiotics.”
This double-blind, global study, OPTIC-2, demonstrated that omadacycline met the primary endpoint of statistical non-inferiority to moxifloxacin at 72-120 hours after treatment initiation. Clinical success rates were 89.6% for omadacycline and 87.7% for moxifloxacin, underscoring its effectiveness.1
“Guideline updates have been historically slow, especially for CABP. With this new data and the largest pneumonia program in over a decade, we envision the ATS/IDSA CAP guidelines would be rapidly updated to include omadacycline as an oral and IV first line-agent for the treatment of CABP. We believe there’s an urgent need for these societies to act on behalf of patients so they can improve access to a highly effective treatment,” Brenner added.
3 Key Takeaways
- Paratek Pharmaceuticals' phase 3 trial results for omadacycline in treating CABP show it effectively met non-inferiority to moxifloxacin with an 89.6% clinical success rate, highlighting its efficacy against drug-resistant bacteria.
- Omadacycline demonstrated a favorable safety profile in the trial, with manageable side effects including headache and minimal gastrointestinal issues, positioning it as a potentially well-tolerated option for outpatient treatment.
- These findings could lead to updated treatment guidelines and FDA label enhancements for omadacycline, potentially increasing its adoption in clinical practice as a significant antibiotic therapy option for CABP.
Omadacycline also met all secondary endpoints, showing non-inferiority in post-treatment evaluations. The treatment was well-tolerated, with the most common side effects being headache (3.6%), COVID-19 (3.3%), and AST increase (2.1%). Notably, gastrointestinal side effects were infrequent, with no reports of C difficile infection.1
“Nuzyra is a tetracycline antibiotic, a class of antibiotics with more than 80 years of established safety heritage. In addition, Nuzyra has been extensively studied in clinical trials with more than 2600 patients now treated in completed trials,” Brenner noted. “The product has been available commercially in the US for more than 5 years with more than 1.5 million days of therapy and a post marketing safety profile consistent with the tetracycline class, what we have seen in clinical trials, and the FDA prescribing information.In CABP trials conducted by Paratek, omadacycline and moxifloxacin demonstrated safety profiles consistent with their approved United States Prescribing Information (USPIs) and their classes of antibiotics.”
Context and Future Directions
The FDA approved an oral-only dosing regimen for Nuzyra to treat adult CABP. This regimen started with 300 mg taken twice on day one, followed by 300 mg daily for 7 to 14 days. Nuzyra, designed to overcome tetracycline resistance, was effective against Gram-positive, Gram-negative, and drug-resistant bacteria. This approval enabled clinicians to treat patients in outpatient settings, potentially reducing hospitalizations and associated costs. Originally, Nuzyra was approved by the FDA in October 2018 for CABP and acute bacterial skin infections.2
“We are in the process of generating the clinical study report for this study which will take approximately 2 months and will fulfill the post-marketing commitment milestone,” shared Brenner. “Once that is complete, we will engage FDA on a review of the data and begin discussions with them about potential label updates to the USPI.We anticipate that this will include the clinical trial section, the adverse reaction section, and discussions with FDA about the warning and precaution for a mortality imbalance in patients with CABP as there was no imbalance observed in this study.”
The study's positive results may lead to updates in treatment guidelines for community-acquired pneumonia and enhancements in omadacycline's FDA labeling, potentially increasing its adoption in clinical practice. Additionally, the extensive clinical data supports omadacycline's position as a significant option in antibiotic therapy.
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