Paratek to Present Groundbreaking Clinical Data on NUZYRA for NTM and CABP at ATS 2025
核心洞察
Paratek Pharmaceuticals (搜索) will present results from two significant clinical studies of NUZYRA (omadacycline) at the ATS 2025 International Conference, including the first-ever placebo-controlled trial in Mycobacterium abscessus complex (搜索) pulmonary disease.
The Phase 2b study in nontuberculous mycobacterial pulmonary disease (搜索) (NTM PD) addresses a significant unmet need, while the Phase 3 OPTIC-2 study confirms NUZYRA's efficacy and safety profile in community-acquired bacterial pneumonia (搜索).
NUZYRA, a next-generation tetracycline designed to overcome resistance, has established the largest clinical trial dataset in pneumonia across all antibiotics approved by the FDA in the last decade.
Paratek Pharmaceuticals (搜索) announced that data from two significant clinical studies of NUZYRA® (omadacycline) will be presented at the American Thoracic Society (ATS) 2025 International Conference in San Francisco from May 16-21. The presentations will highlight results from groundbreaking research in two challenging infectious disease areas.
"The inclusion of NUZYRA efficacy and safety data in two oral sessions at ATS highlights the importance of these study results for the NTM and CABP communities," said Randy Brenner, Chief Development and Regulatory Officer of Paratek. "The Phase 2b study in NTM is the first ever placebo-controlled clinical trial in MABc pulmonary disease, a population with significant unmet needs."
Pioneering Research in Nontuberculous Mycobacterial Pulmonary Disease
The first presentation will feature results from a Phase 2b double-blind, randomized, placebo-controlled, multi-center study evaluating oral omadacycline in adults with nontuberculous mycobacterial pulmonary disease (搜索) (NTM PD) caused by Mycobacterium abscessus complex (搜索) (MABc). This represents a significant advancement in a therapeutic area with limited treatment options.
According to Brenner, "The clinical symptom and microbiology results from the NTM study broaden the current clinical dataset that supports the idea that omadacycline has clinical utility in this very challenging disease setting."
The presentation, scheduled for May 19 at 9:15 a.m. PST, will provide detailed findings from this landmark study. The Phase 2b results were previously reported by Paratek in November 2024 but will be presented to the scientific community for the first time at this conference.
Confirming Efficacy in Community-Acquired Bacterial Pneumonia
The second presentation will focus on the Phase 3 OPTIC-2 study, which evaluated omadacycline for community-acquired bacterial pneumonia (搜索) (CABP). This global study compared the efficacy and safety of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with moderate to severe CABP.
"With regards to pneumonia, OPTIC-2 delivers post-marketing evidence confirming NUZYRA's efficacy and safety profile in CABP," Brenner noted. "Together with OPTIC-1, Nuzyra has the largest clinical trial dataset in pneumonia across all antibiotics approved by the FDA in the last decade."
The OPTIC-2 study results will be presented on May 21 at 11:00 a.m. PST. This study has been supported in part with federal funds from the Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA (搜索)) under contract number 75A50120C00001.
Expanding Research Portfolio
These presentations follow Paratek's recent announcements of additional NUZYRA data presentations at ESCMID Global 2025 in April, which included studies on skin and soft tissue infections, enterococcal infections, and activity against multidrug-resistant bacteria. The company also presented non-clinical efficacy studies for the treatment and post-exposure prophylaxis of inhalation anthrax and pneumonic plague, supporting NUZYRA's potential use in biodefense.
About NUZYRA
NUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous formulations indicated for the treatment of community-acquired bacterial pneumonia (搜索) (CABP) and acute bacterial skin and skin structure infections (ABSSSI). As a next-generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and other drug-resistant strains.
The drug carries important safety information, including warnings about mortality imbalance observed in the CABP clinical trial, with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. All deaths occurred in patients over 65 years of age with multiple comorbidities.
About Paratek Pharmaceuticals
Paratek Pharmaceuticals (搜索) is a privately held pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing important medical and public health threats. The company was acquired in 2023 by B-FLEXION (搜索) and Novo Holdings (搜索).
In December 2019, BARDA (搜索) awarded Paratek a contract valued at up to approximately $304 million. This contract supports the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, U.S. onshoring of NUZYRA manufacturing, FDA post-marketing requirements, and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.
The upcoming presentations at ATS 2025 represent significant milestones in Paratek's ongoing efforts to expand the clinical utility of NUZYRA and address critical unmet needs in infectious disease treatment.