Antibe Therapeutics Inc. 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.”
References reporting the effects of celecoxib and naproxen in reducing osteoarthritis pain, using the same WOMAC pain scale, have been posted at www.antibethera.com.
About ATB-346 :
ATB-346, an NSAID (non-steroidal anti-inflammatory drug), is a hydrogen sulfide-releasing derivative of naproxen, the most-prescribed NSAID in North America.NSAIDs, a $12 billion/year drug class, are the most commonly used therapy for osteoarthritis, yet their use is associated with a high incidence of gastrointestinal ulceration and bleeding. Extensive pre-clinical studies demonstrate that ATB-346 does not produce the gastrointestinal damage observed with currently available nonsteroidal NSAIDs.
About Antibe Therapeutics Inc. :
Antibe is a revenue-generating, integrated healthcare company focused on providing solutions for the pain, inflammation and regenerative medicine markets. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug, ATB-346, targets the global need for a safer, non-addictive drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer, non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin. www.antibethera.com
Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the dental marketplace. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.com
Contacts :
Antibe Therapeutics Inc.
Dan Legault, 416-473 4095
Chief Executive Officer
