Sustained Therapeutics Reports Positive Phase 2 Results for Its Long-Acting Non-Opioid Medication for Chronic Pain

Plans to seek regulatory approval to commence a Phase III trial in the US and Canada

VANCOUVER, BC, Jan. 8, 2026 /PRNewswire/ -- Sustained Therapeutics Inc. ("Sustained Therapeutics" or the "Company"), a clinical-stage therapeutics company developing a non-opioid treatment for pain, today announced positive results from its Phase 2 clinical trial evaluating ST-01, the Company's novel sustained-release drug. 

ST-01 was designed to deliver sustained, localized, non-opioid pain relief for approximately 28 days from a single injection, addressing a major unmet need for patients with limited effective long-term treatment options. 

The trial was focused on Chronic Scrotal Pain (CSP), a debilitating condition affecting over 5 million men in North America, with 700,000 new cases each year. 

Current treatment options for CSP are limited and often ineffective, ranging from analgesics such as ibuprofen to invasive surgical interventions, with approximately 15% of patients ultimately undergoing surgery. In a recent survey of urologists treating CSP, 80% reported that ST-01 addresses a significant unmet clinical need, citing its potential impact on patient care and its ease of administration, which requires no specialized training.

This Phase 2 trial evaluated the safety and efficacy of repeat monthly dosing of ST-01 compared with standard-of-care therapy with lidocaine alone. The study received regulatory clearance from Health Canada and was conducted across eight clinical sites in Canada, enrolling a total of 63 patients. The trial was designed to reflect real-world treatment patterns and to assess the feasibility and potential benefit of repeated administration.

Results demonstrated that ST-01 was safe and effective, delivering clinically meaningful reductions in pain that were sustained across repeated treatment cycles. The study met both its primary and secondary endpoints. Based on these results, Sustained Therapeutics plans to proceed to Phase 3 trials in Canada and the United States, subject to regulatory approval.

"Many men suffering from chronic scrotal pain are in the prime of their lives and experience persistent, often debilitating pain that significantly impacts their quality of life," said Dr. Martin Gleave, co-founder and Chief Medical Officer of Sustained Therapeutics. "The exciting Phase 2 results reinforce our belief that ST-01 has the potential to reduce or even resolve pain over time with repeat treatment, offering patients a meaningful alternative to existing therapies."

"The opioid epidemic continues to be one of the most pressing public health crises across North America, and far too often patients with long term chronic pain have few non-opioid options," said William Annett, CEO, Sustained Therapeutics. "There is an urgent need for effective, non-opioid alternatives that provide sustained pain relief without contributing to dependency." 

Beyond chronic scrotal pain, Sustained Therapeutics is planning to conduct trials of ST-01 in other chronic pain indications with high unmet needs. These include Chronic Pelvic Pain (CPP), which afflicts about 14 million people in North America, trigeminal neuralgia, and post amputation or "phantom limb" pain. 

In addition to ST-01, Sustained Therapeutics' proprietary sustained-release drug delivery platform has also been customized for the delivery of other medications requiring localized, long-lasting therapy. A Phase 2/3 clinical trial of ST-02, a sustained-release chemotherapy, is underway for Upper Tract Urothelial Carcinoma (UTUC), an orphan disease.

The Company has also developed ST-04 as a treatment for erectile dysfunction in the approximately 30% of men who do not respond to current standard of care ED medications. A Phase 2 study of ST-04 has received regulatory clearance from Health Canada and is projected to begin shortly. 

"One of the defining strengths of our platform is its versatility," Dr. Gleave added. "While chronic neuropraxic pain disorders remain our lead program, these results further validate our approach and open the door to many small-molecule therapies." 

Based on the results of the Phase 2 study, Sustained Therapeutics is advancing ST-01 into its next stage of development and strengthening its leadership team to support continued clinical and corporate momentum.

Individuals interested in learning more about the CSP trial or participating in ongoing studies may contact info@sustainedtx.com.

For more information about Sustained Therapeutics, visit www.SustainedTherapeutics.com.

About Sustained Therapeutics:
Sustained Therapeutics is a clinical-stage company utilizing its advanced clinical and research expertise to develop non-opioid, locally injected sustained-release therapeutics primarily for the treatment of pain. A spin-off from the University of British Columbia and the Vancouver Prostate Centre, their novel sustained-release drug delivery platform has the potential to provide effective, long-lasting solutions for managing chronic pain. The Company also plans to develop the platform to enable sustained release treatments for cancer, erectile dysfunction, and inflammatory diseases. Learn more at sustainedtherapeutics.com.

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Notice Regarding Forward-Looking Statements:
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"), including statements regarding the results of the Phase 2 trial and the potential benefits of the Company's therapeutics. Statements in this document regarding future expectations, beliefs, or plans constitute forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. Without limiting the foregoing, the words "seeks", "believes", "plans", and "indicates" are intended to identify forward-looking statements. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to: those associated with the success of research and development programs, the ability to raise additional funding, and the need to obtain regulatory approval. Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors, including, but not limited to: research and development plans proceeding substantially as envisioned, safety of product, and availability of financing on reasonable terms. Forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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