Antibe Therapeutics Outlines Plan for Otenaproxesul's Acute Pain Program

By: Antibe Therapeutics Inc. via Business Wire

November 01, 2021 at 07:00 AM EDT

- Leverages existing extensive clinical data to shorten development path

- Acute pain clinical program initiating early next quarter

- Third-party commercial studies underway

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies for a wide range of inflammatory conditions, is pleased to provide further detail on otenaproxesul’s development plan for acute pain indications. Further to its October 14^th press release, Antibe has now identified timing for the program’s key regulatory and development milestones for post-operative pain, the Company’s initial acute indication for otenaproxesul.

“With otenaproxesul’s impressive 14-day efficacy and GI safety profile, which is ideally suited for acute pain, we are well-positioned to rapidly bring to market a novel and safe non-opioid analgesic,” commented Dan Legault, Antibe’s CEO. “From a commercial standpoint, we see the $13 billion post-operative pain segment as an ideal springboard to the much broader acute pain market. Combined with the lack of innovation in oral analgesics and the urgent global need for non-addictive alternatives, we expect otenaproxesul to be especially attractive to potential partners. And with the option of funding the entire Phase III program with our current cash position, Antibe has a unique opportunity to shift the treatment paradigm of acute pain.”

Leveraging otenaproxesul’s existing comprehensive clinical data package, Antibe anticipates launching its clinical program for acute pain in early calendar Q1 2022. To this end, the Company has begun collaborating with world-leading acute pain specialists to optimize treatment regimens for post-operative pain use. This includes a series of brief pharmacokinetic (“PK”) and pharmacodynamic (“PD”) studies to determine the go-forward treatment regimens for the Phase II program, including the use of loading doses to ensure rapid analgesic onset.

In parallel, Antibe is undertaking a comprehensive third-party market opportunity and reimbursement study, including revenue projections for the large markets, with results expected in late calendar Q1 2022. This will involve both primary and secondary research, including interviews with surgeons, anesthesiologists and pain specialists. Subsequently, the Company plans to initiate a partner targeting study to support strategic outreach as the drug’s therapeutic and commercial potential is fully validated.

With the optimal treatment regimens and commercial data in hand, the Company will prepare for otenaproxesul’s Phase II program, slated to commence in calendar Q4 2022. Involving only a single efficacy trial with a treatment period of up to 10 days, it is expected to deliver top-line data in six months. This trial will employ a surgical bunionectomy model, recognized as one of the most reliable methods for evaluating analgesic efficacy in post-operative pain. Given the extensive animal data already available for otenaproxesul, the Company does not anticipate the need for additional animal studies for its acute pain program.

Upon success of this Phase II trial, the Company will request an end of Phase 2 meeting with the U.S. FDA to discuss the Phase III program. Given the short treatment durations employed in acute pain trials, it is anticipated that the full Phase III program can be completed within 12 months. This includes two concurrent, pivotal efficacy trials to assess post-operative pain relief for the following surgical procedures: (i) the hard tissue model of bunionectomy, replicating the Phase II trial with a larger sample size; and (ii) abdominoplasty, a widely accepted soft tissue surgical model. The Company intends to apply for marketing approval for a broad acute pain indication.

Anticipated Milestones

The following summarizes the Company’s estimated development timeline for otenaproxesul’s post-operative pain indication:

PK/PD clinical studies initiated – Q1 2022
Third-party commercial study results – Q1 2022
Optimal treatment regimens determined – Q3 2022
Phase II bunionectomy trial initiated – Q4 2022
End of Phase 2 meeting and initiation of 12-month Phase III program – H2 2023

Upon marketing approval, Antibe plans to initiate a series of studies to further investigate the effectiveness of otenaproxesul in other acute pain indications such as migraine, dysmenorrhea, blunt trauma and gout, all large markets with few safe and effective therapies.

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 in clinical development as a safer alternative to opioids for acute pain and the treatment of osteoarthritis. Additional assets include GI-sparing alternatives to ketoprofen and low-dose aspirin. The Company’s anticipated next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.

Forward Looking Information

This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, the anticipated scope, timing, duration and completion of certain of the Company’s clinical trial programs and studies and the anticipated timing for seeking market approval for certain of the Company’s drugs and therapies for certain additional indications. 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 timely execute on its business strategy and timely and successfully compete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug and medical device development generally and those risk factors set forth in the Company’s public filings made in Canada and available on www.sedar.com. The Company 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.