On October 18, 2021, biopharmaceutical company Paratek Pharmaceuticals, Inc. (“Paratek”) shared via news release that the first patient had enrolled in a Phase 2b clinical trial. Within the trial, researchers seek to evaluate the safety, efficacy, and tolerability of NUZYRA (omadacycline) for patients with nontuberculous mycobacterial (NTM) lung disease resulting from Mycobacterium abscessus complex (MABc). To learn more about the clinical trial, which will eventually enroll around 75 patients, click here.
NUZYRA
The U.S. Food and Drug Administration (FDA) describes NUZYRA as a tetracycline-class antibacterial treatment. It is currently indicated for use in adults with either acute bacterial skin and skin structure infections (ABSSSI) or community-acquired bacterial pneumonia (CABP).
While the therapy is currently being used for CABP and ABSSSI, researchers believe that it could have benefits for patients with NTM lung disease. Each year, an estimated 11,500 Americans experience lung infections resulting from MABc. These infections can be difficult to treat and often require a variety of antibiotic therapies. Currently, no approved treatments exist for MABc infections. Thus, NUZYRA has the potential to fill an unmet need for those facing these infections.
NUZYRA can be given either orally or intravenously, depending on the patient’s needs. It is also specially designed to overcome resistance to tetracycline-class therapies. While NUZYRA is relatively safe and well-tolerated, there are some things to think about:
- The most common adverse reactions include nausea and vomiting; insomnia; constipation or diarrhea; high blood pressure; headaches, and infusion-site reactions.
- However, there are some more serious adverse reactions which may occur. These include permanent tooth discoloration, enamel hypoplasia, hypersensitivity and allergic reactions, severe diarrhea, or pancreatitis.
- In a CABP clinical trial, which compared NUZYRA to moxifloxacin, patients did occur in both trial arms. While 4 patients treated with moxifloxacin died, 8 patients treated with NUZYRA died. As of yet, the cause of the imbalance between fatalities is not known.
Nontuberculous Mycobacterial (NTM) Lung Disease
Nontuberculous mycobacterial (NTM) lung disease is an infectious disease caused by mycobacteria, which live in soil and water. Many people are exposed to these mycobacteria. However, a majority are not infected. Those who are immunocompromised, or have other health conditions such as cystic fibrosis (CF) or alpha-1 antitrypsin deficiency (A1AD), are at an increased risk of developing NTM lung disease. Once the mycobacteria are breathed in, they infect the lungs, airways, and other tissue, causing a chronic and difficult-to-treat lung infection. Symptoms of NTM lung disease include:
- Fever and night sweats
- Fatigue
- Unintended weight loss
- Repeated respiratory infections
- Shortness of breath and/or difficulty breathing
- A severe, persistent cough which might produce blood
