Antibe Therapeutics Provides Corporate Update
Antibe Therapeutics Inc.:
- Phase II secondary data confirmed remarkable potency of ATB-346 -
- 3rd party commercial studies project peak annual sales of $5.3 billion across seven key countries -
- Large market partnering efforts to accelerate in parallel with Phase III program -
- Non-opioid painkiller advancing towards the clinic; pipeline expansion initiatives underway -
To our shareholders,
As we transition into a Phase III company, we want to take the opportunity to highlight recent progress and to outline our strategy as we pursue monetization of our promising drug candidates and hydrogen sulfide platform.
Analysis of Phase II Dose-Ranging, Efficacy Data Now Complete
Having completed the analysis of primary and secondary data from ATB-346’s recent placebo-controlled efficacy trial, we can confidently report strong results across all key measures.
The WOMAC pain scores constituting the study’s primary endpoint showed 44% improvement from baseline at day 14 for the 200 and 250 mg once-daily doses, and 39% for the 150 mg once-daily dose. NSAIDs typically reach their maximum effectiveness after 6-8 weeks of administration and remain at that level while treatment continues. ATB-346 produced significant decreases in pain within 2 weeks of treatment. All three doses of ATB-346 reflect well in light of results from a recent peer-reviewed meta-analysis of historical NSAID osteoarthritis pain trials from Harvard researchers1. (For further information, please see our website and updated Corporate Presentation).
Beyond the impressive pain relief, ATB-346 also delivered significant improvements in the two secondary endpoints that address therapeutic benefit for patients: the WOMAC scores for stiffness and for difficulty in performing daily activities. These results are important, ‘real-world’ measures for patients with osteoarthritis (“OA”) and provide additional support for the drug’s best-in-class positioning.
Supplementing the WOMAC results are the secondary data of cyclo-oxygenase (“COX”) enzyme inhibition. NSAIDs reduce pain and inflammation by inhibiting the activity of COX enzymes. ATB-346 exhibited profound inhibition of COX (all doses yielding >90% inhibition) with a very high degree of statistical significance, and with negligible difference observed across the three doses. This is exceptionally strong data that is consistent with self-assessment of pain by the patients.