Boston-based Paratek Pharmaceuticals has released positive topline data from a Phase IIb trial evaluating its oral antibiotic Nuzyra (omadacycline) in adult patients with nontuberculous mycobacterial (NTM) pulmonary disease.
The therapy showed an improvement in at least 50% of the NTM symptoms present at baseline and no worsening of any baseline symptom. The company was quick to note that "while the study was not designed to formally test for statistical differences between treatment arms, a trend favouring omadacycline was consistently observed across top line primary and secondary endpoints."
Paratek was acquired by Novo Holdings and Gurnet Point in a deal worth approximately $462m in September 2023. Nuzyra is Paratek's lead therapy and is approved by the US Food and Drug Administration (FDA) as a treatment for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). GlobalData expects the therapy to generate $119m in 2030.
GlobalData is the parent company of Clinical Trials Arena.
The placebo-controlled Phase IIb trial (NCT04922554) enrolled 66 patients with NTM pulmonary disease caused by mycobacterium abscessus. The study evaluated the primary efficacy endpoint of treatment response on the NTM Symptom Assessment Scale at Day 84 in two ways.
The first evaluation defined a positive response as an improvement in at least 50% of the NTM symptoms present at baseline. The second approach required an improvement in at least 50% of the NTM symptoms present at baseline along with no worsening of any baseline symptom.
In the first evaluation, 34.1% of the participants demonstrated a favourable trend towards higher response rates compared with 20% of the placebo treated subjects. The second evaluation saw 34.1% of the treatment participants showing a favourable trend towards higher response rates compared with 12% of the placebo group.
Nuzyra also showed improvement in microbiological endpoints, with 56.4% of treatment group patients having negative sputum cultures for mycobacterium abscessus compared to 29.2% of the placebo group. At 84 days, 76.5% of the Nuzyra group saw a reduction in semi-quantitative sputum culture scores compared to 45.8% of placebo treated patients.
The common treatment emergent adverse events were gastrointestinal symptoms, with four patients discontinuing treatment due to these. Paratek noted that the study data analysis is ongoing, with the company intending to present and publish complete data at a later date.
"Paratek's antibiotic succeeds in Phase IIb lung disease trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.