TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. ("Antibe" or the “Company”) (TSXV: ATE, OTCQB: ATBPF), a leader in developing safer therapeutics for pain and inflammation, is pleased to provide an update on its clinical development activities for its lead drug, ATB-346.
The Phase 2 dose-ranging, efficacy study remains on track to commence this quarter. Furthermore, as per the recent CEO letter to shareholders, Antibe has been pursuing additional development activities that are required for regulatory approval and of strategic value to future partners. In that regard, the Company recently completed a series of animal metabolism studies that have provided key insights on the pharmacokinetic (“PK”) profile of ATB-346. Importantly, these insights can now be leveraged to better determine the doses and dosing regimens to be used in the upcoming Phase 2 study.
“Based on the recently reported COX inhibition data and metabolism insights, we have augmented our Phase 2 dose-ranging, efficacy study for ATB-346 to include two protocols,” remarked Dan Legault, Antibe’s CEO. “The first protocol will expand upon the metabolism findings which should enable us to better select the optimal doses for the subsequent protocol. Although this modestly extends the timelines of the overall study, it provides a faster path to obtaining the comprehensive package of efficacy and metabolism data that is required for regulatory bodies such as the FDA, and valued by global partners.”
Upcoming Phase 2 Study De-Risked by Inclusion of Metabolism Protocol
The upcoming Phase 2 study will now include a metabolism protocol that will directly inform the dosing cohorts (i.e., the doses and dosing regimens) to be used in the subsequent dose-ranging, efficacy protocol. Thus, the augmented development plan will include two parts:
- Part 1: Characterization of Metabolites. The primary objective of the metabolism study is to determine the principle metabolites of ATB-346 in humans and characterize their activity and PK profile. The study will be conducted in approximately 25 healthy volunteers and is anticipated to commence this quarter and should take 8-10 weeks to complete.
- Part 2: Validation of Effectiveness. The dose-ranging, efficacy study will be conducted in approximately 200 osteoarthritis patients. The primary objective of the study is to evaluate the efficacy of ATB-346 in reducing pain at three doses (versus control) and establish the lowest effective dose. The profile of each ATB-346 dosing cohort will be finalized based on the findings of the above-mentioned metabolism protocol. A top-line data read-out from this study is anticipated in Q2 2019.
Antibe estimates that the full Phase 2 study (including the metabolism protocol) will cost approximately $3 million and will be funded with cash-on-hand. The Company will provide regular updates on the progress and timing of the study.
Recently Completed Metabolism Studies Show Promising Results
Antibe recently concluded a series of animal studies with an objective of further characterizing the metabolic profile of ATB-346. Clinical studies conducted to-date indicate that ATB-346 is far more potent than naproxen and suggests one or more active metabolites are contributing to the mechanism of action. The recently obtained data on several metabolites of ATB-346 provide significant insights to understanding the increased potency and duration-of-activity of the drug. A defined understanding of a drug’s mechanism of action and metabolism is a key requirement for regulatory approval and will also support partnering discussions. These metabolism studies were conducted by a leading clinical research organization (“CRO”) in the United States.
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.
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 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.