Paratek Pharmaceuticals to Present New Data on NUZYRA® (omadacycline) at ESCMID Global 2025

Highlights will include data from non-clinical and real-world patient use

/EIN News/ -- BOSTON, April 10, 2025 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company developing specialty therapies for community care and public health challenges, today announced that data from several new studies of NUZYRA^® (omadacycline) will be presented at ESCMID Global 2025, the Congress of the European Society of Clinical Microbiology and Infectious Diseases, taking place in Vienna, Austria, April 11-15.

“We continue to invest in science as part of our commitment to furthering the medical community’s understanding of NUZYRA,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “This week’s ESCMID presentations will include data from non-clinical efficacy studies for the treatment and post-exposure prophylaxis of inhalation anthrax and pneumonic plague, supporting NUZYRA’s potential use in biodefense. In addition, researchers will share data on skin and soft tissue infections, enterococcal infections, and activity against Acinetobacter baumannii-calcoaceticus complex isolates."

NUZYRA Presentation Details
Presentation Title: Omadacycline for skin and soft tissue infections: a multicentre retrospective analysis of efficacy and safety in real-world clinical practice
Time/Location: April 13, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D
Abstract #: 04456
Session Title: 02f. Community-acquired skin, soft tissue, bone & joint infections (incl epidemiology, clinical, imaging, treatment & prevention, excl prostheses)
Poster #: P1095

Presentation Title: Clinical efficacy and safety of omadacycline in the treatment of enterococcal infections
Time/Location: April 13, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D
Abstract #: 03861
Session Title: 02f. Community-acquired skin, soft tissue, bone & joint infections (incl epidemiology, clinical, imaging, treatment & prevention, excl prostheses)
Poster #: P1092

Presentation Title: Omadacycline demonstrated efficacy as both therapeutic treatment and post-exposure prophylaxis against inhalation anthrax and pneumonic plague in cynomolgus macaques
Time/Location: April 13, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D
Abstract #: 01058
Session Title: 11. Public health & vaccines
Poster #: P3784
(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.)

(The Pneumonic Plague-related project has been funded by the Rapid Acquisition and Investigation of Drugs for Repurposing program within the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for CBRN Medical.)

Presentation Title: Activity of omadacycline against multidrug-resistant and molecularly characterised Acinetobacter baumannii-calcoaceticus complex clinical isolates from United States hospitals, 2020–2023
Time/Location: April 14, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D
Abstract #: 02641
Session Title: 03b. Resistance surveillance & epidemiology: Healthcare-associated bacteria
Poster #: P1314

About Paratek Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for community care providers and specialists, 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 a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals 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
adam@scientpr.com