- Acute pain program launched for otenaproxesul

- New patent application aimed at extending otenaproxesul’s IP protection into the 2040s

- Dosing regimen for osteoarthritis indication requires additional investigation

- Company fully funded into 2024

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 an update following a full scientific and strategic review involving external experts and key opinion leaders. The key findings are:

• Lead drug, otenaproxesul, ideally suited for US$13 billion post-operative pain market
• Targets urgent need to reduce opioid prescriptions, with shorter path to market envisaged
• Label expansion strategy potentially includes migraine, dysmenorrhea and dental pain
• Enlarged pipeline addresses significant unmet medical needs, additional IP protection expected
• Chronic pain program investigating alternative treatment regimens
• Strong balance sheet fully funds multiple parallel clinical development programs

“In our comprehensive review, it became apparent that otenaproxesul’s remarkable potency, GI protection and overall safety profile should be leveraged for acute pain use,” commented Dan Legault, Antibe’s CEO. “Short-term pain management has its own considerable challenges, not the least being a continued reliance on opioids, for which otenaproxesul is an ideal fit. Building on commercial research already in hand, we are initially targeting post-operative pain, with a plan to add further acute pain indications over time. Importantly, given the relatively short trials required, we foresee a faster path to market than originally envisaged with our chronic pain program. We are also pursuing a new indication with high unmet need for ATB-352, harmonizing its development with otenaproxesul’s new acute pain program.”

Otenaproxesul’s Osteoarthritis Program to Explore Alternative Dosing Regimens

In collaboration with outside experts and key opinion leaders, the Company has completed a comprehensive assessment of the AME study data. In addition to the three subjects described in the August 3rd press release, a further three subjects exhibited liver transaminase elevations (“LTEs”) exceeding five times the upper limit of normal, which occurred following the four-week drug administration period. All six subjects, including five in the 100 mg cohort and one in the 75 mg cohort, completed their in-clinic observation period without any additional safety findings. Notably, all LTEs were transient, self-limiting and required no clinical intervention.

The review confirms that the observed LTEs are a dose-dependent, drug-related effect and present a challenge for daily drug administration over longer treatment durations. The mechanism underlying the LTEs is being intensively researched in collaboration with recognized liver scientists. To date, the evidence suggests that daily doses administered for longer treatment durations leads to increased hepatocellular oxidative stress, triggering LTEs in a subset of individuals. Increased oxidative stress is a common finding associated with widely used medications, including nonsteroidal anti-inflammatory drugs (“NSAIDs”) and acetaminophen. The Company is investigating alternative dosing regimens as a potential path forward for chronic indications.

Acute Pain Program Launched for Otenaproxesul

The Company has commenced an acute pain program for otenaproxesul to harness its demonstrated potency, profound gastrointestinal (“GI”) protection and a safety profile that remains suitable for short-term treatment regimens. Initially targeting the post-operative pain market, the Company intends to expand to indications such as migraine, dysmenorrhea and dental pain – all large markets with few safe and effective therapies.

The global market for post-operative pain is estimated to be US$13 billion, with opioids and NSAIDs accounting for the majority share (Transparency Research). In the U.S., there are 50 million surgical procedures annually that require post-operative pain medication and more than two million Americans may become persistent opioid users each year (Brummett et al.).

“The resurgent opioid crisis is pressuring prescribers, payors and policymakers to reduce the use of opioids across medical practice,” commented Dr. Joseph Stauffer, Antibe’s Chief Medical Officer. “In particular, the treatment of post-operative pain continues to rely on opioids, with little innovation addressing the period beyond two to three days following surgery, when the transition to home care generally occurs. With extensive human clinical data on otenaproxesul already in hand, we are well-equipped to pursue a solution to this long-intractable problem.”

In a commercial study of acute pain conducted by leading life science strategy consultancy, Shift Health, GI safety was cited as the top concern amongst surgeons and clinicians prescribing NSAIDs in a hospital setting. Antibe's Phase IIB GI safety trial showed that patients administered prescription naproxen for fourteen days exhibited a 42% incidence of 3 mm ulcers, compared to 2.5% in those taking otenaproxesul.

Research is underway to identify optimal dosing regimens for otenaproxesul in acute pain indications, with initial clinical studies expected to begin in the upcoming quarter. Because acute pain is inherently a short-term indication, the Phase II and III clinical trials required to establish safety and efficacy are also relatively short, enabling a more rapid time to market than was envisaged for the original chronic pain development program.

New Patent Applications Potentially Extend IP Protection

The Company has filed a patent application that covers the novel dosing regimens envisaged for acute use of otenaproxesul. In addition, Antibe also recently identified an attractive specialized indication for ATB-352 for which new IP is being sought. If granted, both drugs will benefit from new IP protection in major markets into the 2040s.

IBD Program Progressing Toward Candidate Selection

The Company’s Inflammatory Bowel Disease (“IBD”) candidate is expected to be selected in the coming quarters, with IND-enabling studies to begin immediately thereafter. Intended to address the need for a safe and more effective drug for mild to moderate IBD, its product strategy aims to delay or avoid the requirement for expensive and side effect-prone steroids and biologics. The new IBD candidate is being designed using the architecture of ATB-429, a hydrogen sulfide-releasing IBD drug acquired via the recent amalgamation with Antibe Holdings that has extensive and promising animal data but diminishing patent life. Covering treatments for Crohn’s disease and ulcerative colitis, the IBD market is expected to nearly double between 2019 and 2029 to US$25 billion (Global Data).

Strong Balance Sheet to Drive Development Programs

The Company’s cash position as of September 30, 2021 was $60 million, which fully funds all development activities into calendar 2024.

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 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, 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.

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