TORONTO, ONTARIO – (August 8, 2016) – 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.”
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 NSAIDs.
About Antibe Therapeutics Inc.
Antibe develops safer medicines for pain and inflammation. 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 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 orthopedic and dental marketplaces. 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
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Forward-Looking Information
This news release includes certain forward-looking statements, which may include, but are not limited to, the growth of product sales, engaging new distributors and independent representatives, the completion of financing transactions and the licensing and development of drugs and medical devices. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar expressions. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s ability to secure additional financing, its inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics Inc. assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.
Contact Information
Antibe Therapeutics Inc.
Dan Legault
Chief Executive Officer
Tel: +1 416-473-4095
dan.legault@antibethera.com