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 September 30, 2019.
Phase 2B Dose-Ranging, Efficacy Study Nearing Completion
The Company’s on-going 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 surpassed 70% and patient recruitment has accelerated due to several initiatives, including the activation of an additional five clinical sites. This brings the total number of clinical sites to 40, the largest number of sites for any clinical trial ever conducted in Canada.
Dan Legault, Antibe’s CEO, remarked, “We’re pleased with the conduct of the study, although enrollment has been slower than originally anticipated. We’ve taken extra measures to expedite the completion of enrollment, but with the inevitable slowdown during the holiday season, we are pushing our guidance for top-line data to calendar Q1 2020.”
The Company will issue a press release upon enrollment of the last patient.
Balance Sheet Remains Strong; Recent Benefit from Warrant Activity
Antibe reported a cash balance at September 30, 2019, of $8 million, which reflects the successful prospectus offering that was concluded in August. Subsequently, the Company has raised $1.3 million from the exercising of warrants. The Company’s unaudited fiscal Q2 2020 condensed interim consolidated financial statements and MD&A will be available on SEDAR today.
Continued Progress with FDA Regulatory Requirements
The Company recently requested a Pre-Investigational New Drug (“IND”) meeting to support its IND filing with the FDA and, in parallel, is preparing for an end-of-Phase-2 FDA meeting. A successful IND filing will allow for Phase 3 testing of ATB-346 in the United States. In combination with a successful end-of-Phase-2 FDA meeting, Antibe will have achieved a valuable regulatory milestone for potential partners seeking a Phase 3-ready asset. In addition, the Company is pursuing the equivalent regulatory pathway with the EMA to prepare ATB-346 for approval in Europe.
Preparing for Global Pharma Partnerships
The Company has advanced several independent market research initiatives aimed at global partners, who will be focusing on commercialization strategy as ATB-346 nears approval. This includes a recently completed health economics study on the overall cost of NSAID-related adverse events in the United States. The study estimates that direct costs associated with NSAIDs, including the treatment of adverse events, total approximately $74 billion annually in the United States. It also estimates that the introduction of ATB-346 could deliver significant savings to the US healthcare system.
In addition, Antibe recently completed a commercial positioning study for ATB-346, and has now engaged a leading life science-focused consulting firm to conduct a comprehensive market opportunity assessment and payor study for both the United States and Europe. Collectively, these initiatives will complement the scientific and clinical data that Antibe shares with potential partners.
Global Supply Secured for ATB-346
Antibe is pleased to announce that it recently engaged a leading global contract manufacturing organization (“CMO”) for ATB-346. This contract supports the interests of Antibe and its potential global partners by securing a reliable supply of ATB-346 to meet regulatory approval timelines.
New Corporate Website Reflects Maturing Stage of Company
The Company has launched its new corporate website reflecting its refreshed brand and identity. The new website contains in-depth information on Antibe’s science, drug pipeline and market opportunity, making it a valuable resource for investors and future partners.
Issuance of Restricted Share Units
It is the Company’s standard practice to grant equity compensation awards on an annual basis. A total of 7,630,000 restricted share units (“RSUs”) were granted to directors, officers, employees and consultants pursuant to the Company’s RSU plan. The vesting of 50% of the RSUs granted to key executives will be subject to the achievement of specific performance goals that reflect the successful execution of the Company’s business plan and strategy. In addition, 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 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. 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 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 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 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.