#Canada #Vancouver #Chronic Pain #Sustained Therapeutics #ST-01

Sustained Therapeutics Advances Pain Management

Sustained Therapeutics Inc., a company in the clinical development stage, has recently revealed promising outcomes from its Phase 2 clinical trial of ST-01, a non-opioid medication designed for managing chronic pain. The company is now aiming for regulatory approval to initiate Phase 3 trials in both the U.S. and Canada.

ST-01 offers a novel approach, providing sustained, localized pain relief for approximately one month following a single injection. This innovation addresses a critical gap in the treatment options available for patients suffering from chronic pain, particularly those with Chronic Scrotal Pain (CSP), a condition that affects over five million men in North America. Each year, around 700,000 new cases of CSP are reported, illustrating the urgent need for effective treatment solutions.

Current treatment methods for CSP are often inadequate, ranging from simple analgesics like ibuprofen to more invasive surgical procedures. It’s alarming that about 15% of patients eventually need surgery, highlighting the ineffective options available. In a recent survey conducted among urologists treating CSP, an impressive 80% agreed that ST-01 addresses a significant unmet medical need, recognizing its potential to improve patient care due to its ease of administration, which does not require specialized training.

Clinical Trial Insights

The Phase 2 trial meticulously evaluated the safety and efficacy of ST-01 through repeated monthly doses, directly compared with the standard treatment of lidocaine alone. Conducted across eight clinical sites in Canada, the study enrolled a total of 63 patients and successfully obtained regulatory clearance from Health Canada. By mirroring real-world treatment scenarios, the trial aimed to assess the feasibility and potential advantages of repeated administration of ST-01.

The results indicated that ST-01 is not only safe but also efficacious, delivering significant and sustained reductions in pain across multiple treatment cycles. The trial achieved both its primary and secondary endpoints, further validating the medication's potential. Following these compelling results, Sustained Therapeutics is optimistic about moving forward to Phase 3 trials in North America, pending regulatory endorsement.

Expert Perspectives

Dr. Martin Gleave, co-founder, and Chief Medical Officer of Sustained Therapeutics emphasized the importance of these findings, stating, “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.” He expressed confidence that ST-01 could significantly reduce or even eradicate pain over time through repeated treatments, offering a valuable alternative to existing therapies.

William Annett, the company’s CEO, pointed out the ongoing opioid crisis, which presents patients dealing with chronic pain with a limited selection of non-opioid treatments. He articulated the pressing demand for effective strategies that ensure sustained pain relief while averting the complications associated with opioid dependency.

Future Directions

In addition to addressing chronic scrotal pain, Sustained Therapeutics is ambitious about exploring ST-01 for other chronic pain conditions with pronounced unmet needs. These include Chronic Pelvic Pain (CPP), affecting roughly 14 million people in North America, trigeminal neuralgia, as well as post-amputation pain, commonly referred to as phantom limb pain.

Furthermore, the company's proprietary sustained-release drug delivery system shows promise for other therapeutic applications. Currently, a Phase 2/3 clinical trial of ST-02—another sustained-release formulation aimed at treating Upper Tract Urothelial Carcinoma—is underway. Additionally, ST-04 is in development for treating erectile dysfunction in men who do not respond to standard treatments, with a Phase 2 study anticipated to begin following regulatory approval.

Dr. Gleave added, “Our platform's versatility is one of its defining strengths; while chronic neuropraxic pain disorders remain our lead initiative, these results underline our approach's validity and their capacity to facilitate various small-molecule therapies.”

Given the extraordinary results from the Phase 2 study, Sustained Therapeutics is progressing with the development of ST-01 while bolstering its leadership team to maintain clinical and corporate momentum in the burgeoning field of pain management.

For those interested in participating in ongoing studies or learning more about the CSP trial, engagement is encouraged through the company’s contact point. For further details on Sustained Therapeutics, their advancements, and their commitment to providing long-lasting pain relief solutions, visit Sustained Therapeutics.