Once shares of Antibe Therapeutics Inc. (TSX-Venture:ATE) (OTCQB:ATBPF) had their trading halt lifted, the company announced that its lead drug, ATB-346, met its primary endpoint in the Phase 2B gastrointestinal (“GI”) 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 to naproxen, the most prescribed nonsteroidal anti-inflammatory drug ("NSAID") in the USA.
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 2-week treatment period, with a very high degree of statistical significance (p<0.001). ATB-346 was also safe and well tolerated.
As a result of the positive results, shares shot up 78% in early-afternoon trading on very high volume as shareholders cheered on the impressive data.
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 three (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."
"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."
Shares of ATE are trading up $0.28 at $0.64 at last check as they hit a new 52-week high on the news.
