Paratek Pharmaceuticals to Present Clinical Data on NUZYRA® (omadacycline) at the American Thoracic Society (ATS) 2025 International Conference

• First conference presentations for:
  • Phase 2b study for nontuberculous mycobacterial pulmonary disease (NTM PD) caused by Mycobacterium abscessus complex (MABc)
  • Phase 3 OPTIC-2 study in moderate-to-severe community-acquired bacterial pneumonia (CABP)

BOSTON, May 16, 2025 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on the development and commercialization of specialty therapies for specialists and community care providers that address important medical and public health threats, today announced that data from two clinical studies of NUZYRA^® (omadacycline) will be presented at the ATS 2025 International Conference (ATS 2025), taking place in San Francisco, CA, May 16-21.

“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. The Phase 2b study in NTM is the first ever placebo-controlled clinical trial in MABc pulmonary disease, a population with significant unmet needs,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “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. With regards to pneumonia, OPTIC-2 delivers post-marketing evidence confirming NUZYRA’s efficacy and safety profile in CABP. Together with OPTIC-1, Nuzyra has the largest clinical trial dataset in pneumonia across all antibiotics approved by the FDA in the last decade.”

Presentation Details
Oral Presentation Title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Omadacycline in Adults With Nontuberculous Mycobacterial Pulmonary Disease (NTM PD) Caused by Mycobacterium Abscessus Complex (MABc)
Time/Location: May 19, 9:15 a.m. PST in Rooms 3000, 3002, 3004, Moscone West
Abstract #: 12558
Session Title: B20 NTM, Bronchiectasis, and the Quest to Understand: A Story of Lungs and Love
ePoster #: 12558
(The Phase 2b results were previously reported by Paratek, November 8, 2024.)

Oral Presentation Title: Omadacycline for Community-acquired Bacterial Pneumonia (OPTIC-2): A Phase 3b Randomized, Double-blind, Multicenter, Controlled, Noninferiority Trial
Time/Location: May 21, 11:00 a.m. PST in Room 2014/2016, Moscone West
Abstract #: 11563
Session Title: D96 Pneumonia’s Secret Recipe: A Pinch of Microbiome, a Dash of Host Factors, and a Shot of Vaccine
ePoster #: 11563
(Paratek’s global, Phase 3 OPTIC-2 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. Results from the OPTIC-2 post-marketing study were previously reported by Paratek, July 18, 2024. The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.)

About Paratek Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing important medical and public health threats. Paratek’s lead product, NUZYRA (omadacycline), is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek continues to diversify its portfolio to address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION and Novo Holdings.

In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.

For more information, visit https://www.paratekpharma.com/ or follow us on LinkedIn and X.

About NUZYRA
NUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. 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.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.

WARNINGS AND PRECAUTIONS

Mortality imbalance was 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. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients >65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline class antibacterial drugs. NUZYRA is structurally similar to other tetracycline class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

NUZYRA is structurally similar to tetracycline class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.

Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

DRUG INTERACTIONS

Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.

Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended during treatment with NUZYRA.

See full prescribing information here.

MEDIA CONTACT:
Adam Silverstein
[email protected]

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