Phase 11 is Completed with outstanding results The postulated and primary benefit of ATB 346 is that it eliminates the GI distress that prevents many patients from taking NSAIDs .
That it has ,as well , superior efficacy relative to pain mitigation provided by NSAIDs provides it with an even more elevated profile.
As for LFTs, all NSAIDs report this as a warning on their side effect insert and on packaging.
All that ATB 346 must demonstrate is that any LFT side effect does not exceed LFTs reported for NSAIDs .
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RECENT DEVELOPMENTS
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 researchers[1].
(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.
Adverse events across the three doses of ATB-346 were similar to placebo, with very few serious adverse events or events leading to withdrawal of treatment.
Adjudicating for patient-specific factors reflected a liver safety profile for ATB-346 that was comparable to commonly prescribed NSAIDs, and substantially improved over that of acetaminophen.
Trial participants treated with ATB-346 experienced neither an increase nor decrease in blood pressure in contrast with other NSAIDs, which often increase blood pressure.
Blood pressure increases are viewed by medical practitioners globally as being an important proxy for the cardiovascular risk of NSAIDs.
The absence of an increase in blood pressure has been a consistent finding in all of ATB-346’s clinical trials to-date and suggests a favourable cardiovascular safety profile for the drug.
Human Proof-of-Concept Now Firmly Established for ATB-346
The strong Phase II efficacy results from this trial are a worthy complement to Antibe’s Phase II gastrointestinal (“GI”) safety trial, published last year in the British Journal of Pharmacology[2].
That study demonstrated unequivocal GI safety superiority of ATB-346 over naproxen, one of the most prescribed NSAIDs in the US.
This combined evidence for GI safety and efficacy firmly validates ATB-346 as a potential best-in-class therapy, indicating that we are on the verge of solving one of the most pervasive medical problems of our time, namely the ulcers and bleeding caused by NSAIDs.