A Vancouver-based therapeutics company has begun a second Phase II trial of its novel long lasting non-opioid pain medication, with a specific focus on treating Chronic Scrotal Pain (CSP), a debilitating condition estimated to affect 1% of the male population.
Sustained Therapeutics’ first sustained release drug candidate, ST-01, is designed to slowly release over about 28 days from a single injection.
The initial Phase I trial in CSP showed that the treatment was feasible with encouraging signals of activity. This Phase II trial will explore the possibility of repeated treatments, and will compare the reduction in pain to Standard of Care for this condition.
“Many men suffering CSP are in the prime of their lives, and struggle with decreased quality of life, chronic and often debilitating pain,” says Dr. Martin Gleave, Founder and Chief Medical Office of Sustained Therapeutics.
“Our new therapeutic, specifically customized to treat CSP, could help reduce or eliminate CSP after a series of treatments, and improve quality of life for these men.”
This Phase II trial of ST-01 received regulatory clearance from Health Canada in December 2022, and the company moved quickly to begin screening and enrolling patients.
Currently four sites across Canada are participating in the trial, and the first patient has been enrolled. The trial is planned to take about one year to recruit all the participants, with a further six months of follow-up.
“One of the most important qualities of our drug is that it can be carefully tailored to treat a broad variety of conditions,” says Dr. Gleave. “CSP is our main development focus, and we’re already seeing promising results. Our researchers are focused on identifying more novel candidates to leverage this novel platform to deliver drugs and treat a wide variety of conditions.”
There is a high unmet medical need for an effective long-lasting treatment for CSP. An estimated 1 to 6 million men in the US suffer from CSP, with about 500,000 new cases occurring per year. Current treatments are either very mild, such as recommending NSAIDs, or invasive, including surgery.
While about 15% of patients suffering from CSP do eventually have surgery, many others simply live with chronic, untreated pain. In severe cases some people cannot work, must go on disability, suffer depression and have reduced quality of life.
A recent survey of urologists treating this type of condition found 80% feel Sustained Therapeutics’ new drug meets an unmet need and would significantly increase their ability to help individuals suffering from CSP, providing them a “new tool” in their arsenal.
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