Exciting Developments in Pain Management by Sustained Therapeutics
Plans to seek regulatory approval to commence a Phase III trial in the US and Canada
Sustained Therapeutics Inc., a clinical-stage therapeutics company engaged in the development of innovative non-opioid treatments for pain, recently made headlines with the announcement of positive results from its Phase 2 clinical trial evaluating ST-01, a novel sustained-release drug.
ST-01 was specifically engineered to deliver sustained, localized, non-opioid pain relief for up to 28 days following a single injection. This breakthrough addresses a substantial unmet need for patients who struggle with limited effective long-term treatments for chronic pain.
The focus of the trial was on Chronic Scrotal Pain (CSP), which affects more than 5 million men in North America, with approximately 700,000 new cases identified annually. Current treatment options for CSP are either limited in efficacy or invasive, including reliance on analgesics such as ibuprofen or surgical procedures, with almost 15% of patients resorting to surgery.
In light of this, a recent survey conducted among urologists treating CSP revealed that 80% believe that ST-01 effectively addresses a significant clinical gap, citing its ease of administration that does not necessitate specialized training.
The Phase 2 trial assessed the safety and efficacy of ST-01 through monthly dosing compared to standard therapy of lidocaine. Conducted across eight clinical sites in Canada, the study obtained regulatory clearance from Health Canada and enrolled 63 patients, reflecting true treatment patterns and evaluating the feasibility of repeated administration.
Results were promising, showing that ST-01 was both safe and effective, achieving clinically meaningful reductions in pain that persisted over multiple treatment cycles. The study successfully met its primary and secondary endpoints. Consequently, Sustained Therapeutics is looking to advance to Phase 3 trials in Canada and the United States, pending regulatory approvals.
Dr. Martin Gleave, co-founder and Chief Medical Officer of Sustained Therapeutics, stated, “Men suffering from chronic scrotal pain often find themselves in the prime of life yet endure debilitating pain that impacts their overall quality of life. The exciting results from the Phase 2 trial strengthen our conviction that ST-01 has significant potential to alleviate pain with repeated treatments, providing a meaningful alternative.
William Annett, CEO of Sustained Therapeutics, highlighted the ongoing opioid crisis in North America, stating that many patients with chronic pain face a scarcity of non-opioid options. “The compelling need for effective alternatives to provide sustained pain relief without the risk of dependency cannot be overstated,” he remarked.
Looking ahead, Sustained Therapeutics intends to explore other chronic pain indications that also stipulate a high unmet need, such as Chronic Pelvic Pain (CPP), which impacts approximately 14 million people in North America, trigeminal neuralgia, and phantom limb pain following amputations.
Moreover, ST-01 is not the only innovative treatment in development. Sustained Therapeutics has also customized its proprietary sustained-release drug delivery platform for delivering other medications that require long-lasting localized therapy. A Phase 2/3 study for ST-02, aimed at treating Upper Tract Urothelial Carcinoma (UTUC), is already underway.
In addition to that, ST-04 is being developed as a remedy for erectile dysfunction, specifically targeted at the 30% of men who do not respond to standard ED treatments. This Phase 2 study has already received approval from Health Canada and is set to initiate soon.
Dr. Gleave underscored the versatility of their platform, saying, “While our lead program focuses on managing chronic neuropraxic pain disorders, these recent results validate our approach and open doors for various small-molecule therapies.”
As Sustained Therapeutics progresses ST-01 into its next development phase, the company is also intensifying its leadership team to bolster clinical and corporate advancements.
For details regarding the CSP trial or involvement in ongoing research, interested individuals are encouraged to reach out.
About Sustained Therapeutics:
Sustained Therapeutics is a clinical-stage company capitalizing on advanced clinical and research expertise to pioneer non-opioid, locally injected sustained-release therapeutics primarily targeting pain management. Originating as a spin-off from the University of British Columbia and Vancouver Prostate Centre, their innovative sustained-release drug delivery platform holds promise for delivering effective, long-term pain relief solutions. Additionally, the company aims to adapt this technology for sustained treatments in fields such as cancer, erectile dysfunction, and inflammatory diseases.
Frequently Asked Questions
What is ST-01 and how does it work?
ST-01 is a sustained-release drug designed to deliver non-opioid pain relief for about 28 days from a single injection. It targets chronic pain effectively.
Why is the Phase 2 trial important?
The Phase 2 trial demonstrated ST-01's safety and efficacy, indicating its potential as an alternative to current pain management strategies that are often inadequate.
What conditions is Sustained Therapeutics targeting with ST-01?
Sustained Therapeutics is focusing on Chronic Scrotal Pain, Chronic Pelvic Pain, and other chronic pain types with significant unmet needs.
Are there plans for further clinical trials?
Yes, based on positive Phase 2 results, Sustained Therapeutics intends to seek regulatory approval to move forward to Phase 3 trials in the US and Canada.
What other treatments is Sustained Therapeutics working on?
The company is also developing treatments like ST-02 for cancer and ST-04 for erectile dysfunction, expanding its therapeutic offerings.
