RE:Just for clarity Antibe Therapeutics Inc. (“Antibe”) (TSXV:ATE; OTCQX: ATBPF) is pleased to announce the successful completion of its phase 2 clinical trial of ATB-346 in osteoarthritis (“OA”). Twelve patients with OA of the knee were treated once daily for 10 days with ATB-346 at a dose of 250 mg. This dose of ATB-346 contains one-sixth of the typical daily dose of naproxen for treating OA. This lower dose was very effective at reducing pain, and equal to or better than naproxen or celecoxib in comparable studies. The drug was also safe and well-tolerated.
The patients recorded their level of pain one day prior to starting treatment and again on days 4 and 10 of treatment. The “WOMAC pain scale” was used as the measure of beneficial effect, since it is the gold standard in arthritis clinical trials. “There is a large body of evidence showing that market-leading arthritis drugs like celecoxib and naproxen, taken twice daily for a week or more, typically reduce WOMAC pain scores by ~4 units, with no material improvement beyond that level with continued treatment,” remarked John Wallace, Antibe’s Chief Scientific Officer. “In this trial, a once daily dose of ATB-346 produced a reduction of the WOMAC pain score of 4.3 units on day 4, increasing to 7.6 units on day 10, with a very high level of statistical significance in comparison to baseline pain (p<0.001). The enhanced effectiveness of ATB-346 as compared to the market-leading drugs for osteoarthritis was a pleasant surprise, particularly considering the low dose of ATB-346 that was used.” ATB-346 was well-tolerated, with only one “possibly drug-related adverse event", an allergic reaction graded as “mild” by the study’s supervising physician. This phase 2 clinical trial was carried out in Toronto, Canada by Topstone Research Ltd.
Antibe’s CEO, Dan Legault commented: “We are delighted with these results. Along with ongoing biochemical studies, they suggest that a once daily dose of 250 mg or less will be effective at reducing pain and inflammation in arthritis patients. We plan to expeditiously perform additional clinical trials to confirm the results seen in this phase 2 study, explore the effectiveness of even lower doses of ATB-346, as well as demonstrating increased gastrointestinal safety of this drug in humans.”
woundedknee wrote: This huge trial is based on the results of ATB-346 vs. a placebo is it not? If so, how does this measure against past results vs. naproxan which was on a much smaller scale. Sorry if I am on a once debated question. TIA