TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. ("Antibe" or the “Company”) (TSXV: ATE, OTCQB: ATBPF), a leader in developing safer, non-addictive therapeutics for pain and inflammation, is pleased to provide a corporate update in conjunction with the filing of its financial and operating results for the fiscal quarter ended December 31, 2019.
Enrollment of Phase 2B Dose-Ranging, Efficacy Study Nearly Complete
The Company’s ongoing Phase 2B dose-ranging, efficacy study is evaluating the effectiveness of its lead drug, ATB-346, in reducing osteoarthritis pain compared to placebo in 360 patients. Total enrollment has reached 98% and there are a sufficient number of patients in screening to satisfy the enrollment target. Antibe will issue a press release upon enrollment of the last patient, which is now expected within the next two weeks.
Balance Sheet Continues to Benefit from Warrant Activity
Antibe reported a cash balance of $6.6 million at December 31, 2019. Subsequently, the Company has raised $2.6 million from the exercising of warrants. The Company’s unaudited fiscal Q3 2020 condensed interim consolidated financial statements and MD&A are available on SEDAR.
Pre-IND Meeting with FDA Scheduled for Next Month
The Company is scheduled to meet the FDA for a Pre-Investigational New Drug (“IND”) meeting for ATB-346 in four weeks. This meeting will inform the IND filing with the FDA, which will ultimately allow for Phase 3 testing of ATB-346 in the USA. A successful IND filing in combination with a positive end-of-Phase-2 FDA meeting would strengthen Antibe’s position as it prepares to engage global partners seeking a Phase 3-ready asset.
Issuance of Restricted Share Units
The Company granted a total of 390,000 restricted share units (“RSUs”) to employees and a consultant. All RSUs are subject to time-based vesting; one third (1/3) of the RSUs granted will vest on each of the first, second and third anniversaries of today’s date.
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. Nonsteroidal anti-inflammatory drugs (“NSAIDs”) are the most commonly used therapy for osteoarthritis, but 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.
About Antibe Therapeutics Inc.
Antibe develops safer, non-addictive medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce an 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 post-surgical pain, while ATB-340 is a GI-safe derivative of aspirin. Citagenix Inc., an Antibe subsidiary, is a market leader and worldwide distributor of regenerative medicine products for the dental marketplace. www.antibethera.com.
Forward Looking Information
This news release includes certain forward-looking statements, which may include, but are not limited to, the proposed 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 wording. 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 inability to secure additional financing and licensing arrangements on reasonable terms, or at all, 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 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.