TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. ("Antibe") (TSXV: ATE, OTCQB: ATBPF), a leader in developing safer therapeutics for pain and inflammation, is pleased to announce that it has received approval from Health Canada to initiate the first part of its Phase 2B dose-ranging, efficacy study for its lead drug, ATB-346. The first part of the study is a metabolism protocol that will be conducted in 24 healthy volunteers over a 7 day treatment period. The primary objective of the protocol is to determine the principle metabolites of ATB-346 in humans and characterize their activity and pharmacokinetic profile.
Antibe’s CEO, Daniel Legault, commented, “We are pleased with the approval and excited to begin the first part of this Phase 2B dose-ranging, efficacy study for ATB-346. The results will directly inform the dosing cohorts to be used in the subsequent, larger efficacy protocol. Moreover, this study will further elucidate ATB-346’s unique metabolic profile and will strengthen our data package as we engage regulatory bodies for Phase 3 development and advance strategic partnering activities.”
The metabolism study will commence immediately and is expected to conclude in December 2018. The study will be performed in Toronto, Canada by Boston-based Veristat. The timing of the second part of the dose-ranging, efficacy study remains on track for completion in Q2 2019.
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 conditions such as rheumatoid arthritis, ankylosing spondylitis, gout, 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, non-addictive, GI-sparing anti-inflammatory/analgesic agent such as ATB-346. In March 2018, ATB-346 showed unequivocal superiority to naproxen in GI safety (2.5% versus 42.1% ulceration rate) in a Phase 2B double-blind clinical trial.
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
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.