TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. ("Antibe") (TSXV: ATE, OTCQX: ATBPF) is pleased to announce that it has received approval from Health Canada to initiate a Phase 2, double-blind, gastrointestinal endoscopy trial. The study will involve a total of 240 healthy volunteers, who will be randomized to one of two groups. One group will be treated for 14 days with Antibe’s lead drug, ATB-346 (250 mg once daily), while the other group will be treated for 14 days with the standard prescription dose of naproxen (500 mg twice daily), the most prescribed nonsteroidal anti-inflammatory drug in the USA. Upper gastrointestinal endoscopy will be performed prior to drug treatment, and at the end of the 14-day study period. The study is expected to begin immediately, and will be performed by Topstone Research, in Toronto.
Antibe’s CEO, Daniel Legault, commented “We are pleased with the approval, and excited to begin this GI-safety trial. It is the key trial that we have been building towards for the past few years. Our aim is to demonstrate a substantial, statistically significant reduction of upper GI ulceration with ATB-346 as compared to that with naproxen. This remains the major safety issue with this very large class of drugs. I am also pleased that we remain on the timelines that we have previously announced.” It is anticipated that the study will be completed in early 2018.
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-steroidal anti-inflammatory drug (NSAID) for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer 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 the largest source of knowledge and experience in the Canadian medical device industry. Citagenix Inc. is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.com.
Forward Looking Information
This news release includes certain forward-looking statements which may include, but are not limited to, the development of ATB-346 and other drugs and the addition of products to the company's product line. 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", 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, risks associated with drug development generally, and not obtaining future financing on adequate terms, or at all. 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.