ANNOUNCES SUCCESSFUL PHASE 2B GASTROINTESTINAL SAFETY STUDY FOR LEAD PAIN DRUG, ATB-346
Antibe Therapeutics Inc.'s (ATE.V) lead drug, ATB-346, met its primary endpoint in the phase 2B gastrontestinal safety study. The double-blind study was conducted in 244 healthy volunteers and was designed to demonstrate the superiority of ATB-346 in GI safety compared with naproxen, the most prescribed nonsteroidal anti-inflammatory drug in the United States. Subjects on ATB-346 exhibited an ulceration rate of 2.5% versus an ulceration rate of 42.1% for subjects on naproxen at the end of the two-week treatment period, with a very high degree of statistical significance (p was less than 0.001). ATB-346 was also safe and well tolerated.
Antibe's Chief Scientific Officer, John Wallace, commented, "The successful outcome of this study is the culmination of 15+ years of scientific research, and validates Antibe's hydrogen sulfide-releasing technology. Gastrointestinal safety has been a major global concern with NSAIDs for decades and we now have clinical data unequivocally demonstrating a solution to this unmet and serious medical problem."
Subjects received either 250 mg of ATB-346 once-daily, a dose previously shown to be very effective in reducing osteoarthritis-associated pain, or 500 mg of naproxen twice-daily. The primary endpoint for the study was the incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth, considered the gold standard in assessing the GI safety of NSAIDs. "The number of subjects that developed ulcers while on treatment with ATB-346 was 3 (out of 118), compared to 53 (out of 126) for subjects treated with naproxen," remarked John Wallace. "This result was achieved with an impressive level of statistical significance. In addition, the incidence of elevated liver transaminases in the ATB-346 group was consistent with our expectations and the incidence associated with commonly-prescribed NSAIDs."
The study was conducted by Topstone Research Ltd. ("Topstone") in Toronto, Canada. A detailed summary of the clinical trial results, including secondary endpoints, will be available for release in Q2 2018.
"This extraordinary result exceeded our expectations for ATB-346," remarked Dan Legault, Antibe's CEO. "With human proof-of-concept GI safety data now in hand, Antibe will continue its regional licensing discussions and will now engage global pharmaceutical firms to support our objective of reaching a partnering event for the major markets. In parallel, we will conduct our placebo-controlled dose ranging and effectiveness study with a data read-out expected in Q4 2018. As well, we will accelerate development of Antibe's other novel NSAIDs, including ATB-352, a non-addictive analgesic for the treatment of severe pain that addresses the global opioid crisis."
Changes to the Board of Directors
The Company is pleased to announce the appointment of Amal Khouri (B.Sc., MBA) to its Board of Directors, effective immediately. Ms. Khouri brings extensive pharmaceutical business development experience to the Company and succeeded Samira Sakhia as of March 19, 2018.
"On behalf of the entire team at Antibe, I would like to extend our sincere gratitude to Samira for her invaluable contribution to the Company over the past 3 and a half years," commented Walt Macnee, Antibe's Chairman. "We are also delighted to welcome Ms. Khouri to the Antibe Board. Ms. Khouri has extensive experience in global partnering and licensing deals in the pharmaceutical industry. Her expertise will be a tremendous asset to our Board and shareholders as we prepare to commence global partnering discussions for our lead drug, ATB-346."
Ms. Khouri has more than 15 years of business development experience in the pharmaceutical industry and is presently Vice President of Business Development at Knight Therapeutics Inc. ("Knight"). Prior to Knight, Ms. Khouri worked at Novartis Pharma for over 7 years, where she held multiple positions within the global business development and licensing team in Basel, Switzerland. Before joining Novartis, she worked in business development at Paladin Labs in roles with increasing responsibilities. Ms. Khouri holds a B.Sc. in Biochemistry from McGill University and an M.B.A. from the University of Ottawa.
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. NSAIDs are the most commonly used therapy for osteoarthritis, yet their use is associated with a high incidence of gastrointestinal ulceration and bleeding. NSAIDs are also widely used in a number of conditions, including rheumatoid arthritis, ankylosing spondylitis, and general pain reduction, with a similarly high rate of gastrointestinal ulceration and bleeding. It is well-accepted that patients with these conditions would benefit greatly from an effective, GI-sparing anti-inflammatory/analgesic agent such as ATB-346.
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, non-addictive drug for chronic pain and inflammation. ATB-352, the second drug in Antibe's pipeline, targets the urgent global need for a 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.