-- Highlights include data from clinical, non-clinical and microbiology programs, real-world patient use and a five-year microbiologic surveillance study of NUZYRA
BOSTON, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, announces that data from several new studies of NUZYRA® (omadacycline) will be presented at IDWeek 2024, Oct. 16-19 at the Los Angeles Convention Center in Los Angeles, CA.
“We continue to invest in science as part of our continued commitment to furthering the medical community’s understanding of NUZYRA’s potential utility across a broad range of serious, community-acquired infections, including pulmonary and skin infections,” said Randy Brenner, chief development and regulatory officer of Paratek. “Notably, researchers will share the interim safety results of an open-label, non-inferiority trial of NUZYRA in the treatment of bone and joint infections as well as data from a real-world study assessing both clinical and microbiological outcomes of treatment with NUZYRA for pulmonary Mycobacterium abscessus complex, a rare pulmonary disease that Paratek is also evaluating in a Phase 2 study.”
Oral Presentations
Abstract title: Improving Traditional Registrational Trial Endpoints: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin-Structure Infections
Session: Breaking Ground: ID Clinical Trials
Presenter: Jessica Renee Howard-Anderson, M.D., M.Sc. (Independent research)
Session Date, Time: Thursday, Oct. 17; 10:30 a.m. - 11:45 a.m. (PT)
Session Location: 404 AB
Submission ID: 1828901
Abstract title: Evaluation of Fecal Pharmacokinetics and Metagenomic Changes Following the Administration of Intravenous Omadacycline to Healthy Subjects
Session: Hot Topics in Microbiome Science
Presenter: Kevin Garey, Pharm.D. (Investigator-initiated research)
Session Date, Time: Friday, Oct. 18; 3:15 p.m. - 4:30 p.m. (PT)
Session Location: 411
Submission ID: 1828708
Abstract title: Clinical and Microbiological Outcomes of Omadacycline for Pulmonary Mycobacterium Abscessus Complex
Session: TB and Nontuberculous Mycobacteria Updates
Presenter: Mohammed Al Musawa, Pharm.D., BCIDP (Investigator-initiated research)
Session Date, Time: Saturday, Oct. 19; 3:15 p.m. - 4:30 p.m. (PT)
Session Location: 403 A
Submission ID: 1828690
Poster Sessions
Poster title: Safety of Omadacycline Versus Standard-of-Care Oral Antibiotic Treatment for Bone and Joint Infections: Interim Results from an Open-Label, Non-Inferiority, Randomized Controlled Trial
Poster Session Title: Bone and Joint
Presenter: Amy Y. Kang, Pharm.D., BCIDP (Investigator-initiated research)
Date, Time: Thursday, Oct. 17; 12:15 p.m. - 1:30 p.m. (PT)
Location: Hall J & K
Submission ID: 1828407
Rapid Fire and Poster title: Activity of Omadacycline Against 35,000 Bacterial Clinical Isolates and Resistant Organism Subsets from Patients in the United States (2019–2023)
Poster session: HAIs: Surveillance
Presenter: Michael Huband, B.S. (Paratek research)
Date, Time: Thursday, Oct. 17, 2024; 12:15 p.m. - 1:30 p.m. (PT)
Location: Hall J & K
Submission ID: 1817385
Poster title: In Vitro Activity of Omadacycline and Comparator Agents against a Collection of Neisseria Gonorrhoeae Urine Isolates Collected from the United States During 2018-2020
Poster session: Treatment of Antimicrobial Resistant Infections
Presenter: S.J. Ryan Arends, Ph.D. (Paratek research)
Date, Time: Friday, Oct. 18; 12:15 p.m. - 1:30 p.m. (PT)
Location: Hall J & K
Submission ID: 1829425
Poster title: Current Prescribing Practices and Guideline Concordance for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) across Outpatient and Urgent Care Visits
Poster session: Antibiotic Stewardship: Non-Inpatient Settings
Presenter: Tomefa Asempa, Pharm.D. (Investigator-initiated research)
Date, Time: Saturday, Oct. 19, 12:15 p.m. - 1:30 p.m. (PT)
Location: Hall J & K
Submission ID: 1827423
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings.
The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Zai Lab received approval for both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration of China for the treatment of CABP and ABSSSI in December 2021 and in Macao for the treatment of CABP and ABSSSI in May 2023.
Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex.
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 www.ParatekPharma.com or follow us on LinkedIn and Twitter.
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, 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.
Clostridium 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, 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:
Christine Fanelle
Scient PR
Christine@ScientPR.com
215-595-5211
