- Highlights include pooled safety findings from Paratek’s Phase 3 studies in community acquired pneumonia (CABP) and acute bacterial skin and skin structure infection (ABSSSI), as well as additional clinical and non-clinical data from Company- and investigator-sponsored studies
KING OF PRUSSIA, Pa., April 16, 2026 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on high-need, targeted therapeutic areas, today announced that new data from scientific and investigator-initiated studies of NUZYRA® (omadacycline) will be presented at ESCMID Global 2026, the annual Congress of the European Society of Clinical Microbiology and Infectious Diseases, taking place in Munich, Germany, April 17-21.
“At this month’s ESCMID conference, we will present the most comprehensive safety review to date for NUZYRA in both pneumonia and skin infections, based on data from four Phase 3 trials in more than 1,400 patients,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “In addition, we will have a poster of pivotal data from our rabbit study under the Animal Rule product development program, which we expect will help support a future sNDA submission for NUZYRA for the treatment of pulmonary anthrax. We are also pleased to continue to support high-caliber investigator-sponsored research, as will be presented at this week’s meeting.”
ESCMID Poster Sessions
Poster Title: An Integrated Safety Analysis of Omadacycline in Pivotal Phase 3 Clinical Trials
Session: 05e. Safety, hypersensitivity and adverse effects of treatment
Presenter: Maria Amodio-Groton, PharmD (Paratek research)
Session Date, Time: Sunday, Apr. 19, 12:00 p.m. – 1:30 p.m. CEST (6:00 a.m. – 7:30 a.m. U.S. EDT)
Location: Messe München Poster Hall B3
Poster ID: P3082
(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.)
(The safety analysis integrates data from Paratek’s four Phase 3 studies: two ABSSSI studies (OASIS-1, OASIS-2) and two CABP studies (OPTIC, OPTIC-2). Safety and efficacy data from the OPTIC-2 study were published in December 2025 in eClinicalMedicine, a Lancet Discovery Science journal, https://doi.org/10.1016/j.eclinm.2025.103656.)
Poster Title: Omadacycline Demonstrated Efficacy as Therapeutic Treatment against Inhalation Anthrax in a Blinded, Randomized, Pivotal Study in New Zealand White Rabbits
Session: 09b. Host-pathogen interaction (incl basic microbiome studies, animal models)
Presenter: Alisa Serio, Ph.D. (Paratek research)
Session Date, Time: Monday, Apr. 20, 12:00 p.m. – 1:30 p.m. CEST (6:00 a.m. – 7:30 a.m. U.S. EDT)
Location: Messe München Poster Hall B3
Poster ID: P3998
(The anthrax-related project 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.)
Poster Title: Efficacy and Safety of Omadacycline Oral Step-Down Therapy Following Bloodstream Infection: A Real-World Descriptive Study
Session: 05c. New or repurposed antibacterial agents: Clinical studies and randomised trials
Presenter: Sean Van Helden, PharmD (Investigator-initiated research)
Session Date, Time: Sunday, Apr. 19, 12:00 p.m. – 1:30 p.m. CEST (6:00 a.m. – 7:30 a.m. U.S. EDT)
Location: Messe München Poster Hall B3
Poster ID P2881
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a specialty pharmaceutical company with a portfolio of differentiated medicines serving patients across multiple therapeutic areas. The company integrates and advances commercial-stage assets through disciplined commercial execution, lifecycle management, and clinical development initiatives designed to expand and strengthen its portfolio. Paratek’s products include NUZYRA® (omadacycline), XHANCE® (fluticasone propionate), and TYMLOS® (abaloparatide). Paratek is privately held by B-FLEXION Life Sciences.
In December 2019, BARDA awarded Paratek a PBS 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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