Antibe Therapeutics Inc. (TSXV:ATE) announced positive results from a Phase 2b gastrointestinal (GI) safety study for its lead drug candidate
SmallCapPower | March 21, 2018: Antibe Therapeutics Inc. (TSXV:ATE), a biotechnology company focused on pain and regenerative medicine, Tuesday announced positive results from a Phase 2b gastrointestinal (GI) safety study for its lead drug candidate, ATB-346. Conducted on 244 healthy volunteers, the study met its primary endpoint of lower gastric ulcers compared to naproxen. The Phase 2b safety study follows Antibe’s successful completion of Phase 2a clinical trial in August 2017 in osteoarthritis patients, exhibiting pain relief twice that of NSAIDs like naproxen and celecoxib. With positive results from Phase 2b, the next path for Antibe Therapeutics will be regional licensing discussions that may engage global pharmaceutical firms for major markets. In parallel, Antibe Therapeutics plans to conduct placebo-controlled dose ranging and effectiveness study for ATB-346 with data expected in Q4 2018.
Shares of Antibe Therapeutics surged 78% to close at $0.64 a share on Tuesday.
As part of the Phase 2b study, subjects received either 250 mg of ATB-346 once-daily or 500 mg of naproxen twice-daily, with the primary endpoint being the incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth. Subjects on ATB-346 exhibited an ulceration rate of only 2.5% (3 of 118 subjects) versus an ulceration rate of 42.1% (53 of 126) for subjects on naproxen at the end of the two-week treatment period, demonstrating unequivocal superiority of ATB-346 over naproxen.
Antibe Therapeutics CEO Dan Legault said, “This extraordinary result exceeded our expectations for ATB-346. With human proof-of-concept GI safety data now in hand, Antibe Therapeutics 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.”
Based in Toronto, Antibe Therapeutics is a diversified biotechnology company targeting Pain/Inflammation and Regenerative Medicine. In the Pain segment, the Company is working towards safe and non-addictive treatment of pain/ inflammation designed to prevent widespread gastrointestinal damage and bleeding caused by NSAIDs. Lead candidate, ATB-346 is a new molecule developed by the Company with a moiety that releases hydrogen sulfide (H2S) conjoined to naproxen. H2S activities in the GI tract prevent damages, which is not the case with NSAIDs. Antibe Therapeutics also has two pre-clinical stage candidates in this segment – ATB-352 for Gout, dental pain, post-surgical pain and ATB-340 for stroke and cancer prevention. In the regenerative segment, Antibe Therapeutics has three pipeline candidates for bone regeneration – one in clinical URIST™ (CGX-276) and two in pre-clinical (CGX-443 and CGX-227). The Company’s commercial division in regenerative medicine caters to dental market through its subsidiary, Citagenix Inc. Active in 15 countries, Citagenix operates in Canada via direct sales teams and internationally via network of distributor partnerships.
For the three months ended December 2017, Antibe Therapeutics generated revenues of $2.2 million from its Citagenix business segment. Antibe Therapeutics currently trades at a market cap of $106.04 million on the Toronto Venture exchange.
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