November 8, 2024, Boston, MA – Paratek Pharmaceuticals, Inc. has made a significant announcement regarding positive topline results achieved in its Phase 2b trial assessing the effectiveness of oral omadacycline in treating patients with Nontuberculous Mycobacterial abscessus pulmonary disease. This study marks the first placebo-controlled trial focused on NTM abscessus, a challenging infection that is often resistant to treatment.
The 12 weeks study was conducted on 66 subjects where 41 were given omadacycline and 25 a placebo. Omadacycline treated patients demonstrated improvement in both symptom and microbiological outcomes.
“The results from this first-ever placebo-controlled trial in MABc patients are exciting and support the idea that omadacycline has clinical utility in this very challenging disease setting. Omadacycline treatment demonstrated positive results across multiple clinical and microbiological endpoints in the study,” said Dr. Kevin Winthrop, Principal Investigator and professor at the Oregon Health and Science University.
“The results suggest its potential to become an important addition to the very limited treatment options currently available for patients with Mycobacterium abscessus, providing hope for improved patient outcomes. This is something that clinicians and patients in the NTM community should be very encouraged by.”
Results showed remarkable enhancement in Quality of Life-Bronchiectasis (QOL-B) scores, especially in physical and respiratory functions, as well as increased rates of negative sputum cultures amongst omadacycline patients compared to those in the placebo group (56.4% vs 29.2%).
There were no serious safety issues reported, and omadacycline has a tolerable profile similar to its current approved uses, which means a new treatment option may be available for patients with this complicated disease.
“These findings add to a growing dataset that supports the potential for symptomatic and microbiological improvement with omadacycline for those patients struggling with MABc pulmonary disease,” said Evan Loh, M.D., CEO of Paratek Pharmaceuticals.
“This community needs better treatment options. I want to thank the patients, caregivers, and investigators who participated and made this encouraging outcome possible.”
Source: https://www.paratekpharma.com/investor-relations/press-release?i=140102
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