Earlier initiation of key GI safety clinical trial, facilitating earlier strategic exit discussions
TORONTO, CANADA — (April 18, 2017) – Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSXV: ATE, OTCQX: ATBPF) is pleased to provide an update on its clinical development program for ATB-346, its lead drug that targets the global need for a safer drug for chronic pain and inflammation.
In August of last year, ATB-346 delivered clinical results that were beyond the Company’s expectations in its initial Phase 2 clinical study. Using a once-daily dose of 250 mg (one-sixth of the originally anticipated human dose), ATB-346 showed pain relief nearly double that of naproxen and celecoxib based on comparable studies, the leading drugs in the osteoarthritis market.
As a consequence, Antibe has conducted an extensive review of its development strategy for ATB-346 and has concluded that it is now able to advance the start date of its key Phase 2 proof-of-concept study to demonstrate superior GI safety in humans. Accordingly, Antibe plans to commence this study next quarter and, subsequent to its completion, expects to begin strategic exit discussions in parallel with a Phase 2 dose-ranging effectiveness study.
Dan Legault, Antibe’s CEO, remarked, “We are very excited to be in a position to soon be launching our key human proof-of-concept study for ATB-346, which cuts to the core of its strategic value. The study is powered to provide best-in-class, unequivocal validation of improved GI safety and the revised timing will allow us to engage in global partnering discussions earlier. This effectively advances the timelines of a potential strategic exit for ATB-346. Moreover, we expect to meet our existing budget and overall development timelines, with the GI study to be completed at approximately year-end and the other Phase 2 study to be concluded by the end of Q2/18.”
The first Phase 2, double-blind, upper GI safety study will be an active comparator trial versus naproxen, and will be conducted in 240 healthy volunteers. The primary endpoint will be endoscopically detected upper GI tract ulceration. Subsequently, Antibe plans to launch a Phase 2 placebo-controlled, dose-ranging efficacy study in approximately 200 osteoarthritis patients.
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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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.
Antibe Therapeutics Inc.
Chief Executive Officer
Tel: +1 416-473-4095
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