Antibe Therapeutics Receives FDA Clearance of IND Application for Otenaproxesul for Osteoarthritis Pain

 

Source: Antibe Therapeutics Inc. 3/29/2021

- Enables expansion to U.S.-based clinical trials, advances preparation for Phase III program

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies for inflammation arising from a wide range of medical conditions, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for otenaproxesul, in development for the treatment of osteoarthritis pain. This enables Antibe to undertake human clinical trials in the U.S.; as previously announced, Antibe anticipates initiating its Phase III program later this year.

“We are pleased to have been authorized to proceed with our clinical program for otenaproxesul,” commented Dr. Joseph Stauffer, Antibe’s Chief Medical Officer. “Because we completed Phase II trials prior to the IND application, we were able to provide a comprehensive package of preclinical and clinical data in a submission comprising more than 55,000 pages. We look forward to working with the FDA as we pursue development of a gastrointestinal-protective, non-addictive analgesic for the many millions of patients seeking better medicines for osteoarthritis.” 

About Antibe Therapeutics Inc.
Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation safer therapies to address inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes three assets that seek to overcome the gastrointestinal (“GI”) ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is entering Phase III for the treatment of osteoarthritis pain. Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-protective alternative to low-dose aspirin. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.