Sterotherapeutics launches Phase 2 trial of Cushing’s syndrome therapy
ST-002, designed to block cortisol activity, will be tested in patients
Sterotherapeutics has announced the launch of a Phase 2 clinical trial to test its experimental therapy ST-002 in people with Cushing’s syndrome.
“This trial represents a significant step forward in our mission to develop transformative therapies for unmet medical needs,” Manohar Katakam, PhD, CEO of Sterotherapeutics, said in a company press release.
The study’s goals, according to Sterotherapeutics, will be to evaluate the safety, tolerability, and effectiveness of ST-002 in Cushing’s patients. The company said its Phase 2 trial will take place at sites in Europe, but did not provide further details on study locations, eligibility criteria, or when enrollment is expected to start.
Investigators meeting held this week in support of Phase 2 trial launch
To support the trial’s launch, the company earlier this week held an investigators meeting in Athens, bringing together clinical investigators, research coordinators, and stakeholders to discuss study goals, details of its protocol, and best practices for its successful execution.
Katakam said the company was “excited to convene this important investigator meeting as we progress to the next stage of our clinical development program.”
“Collaboration with our expert investigators is essential to ensuring the highest standards of scientific rigor and patient safety,” Katakam said, citing Sterotherapeutics’ “extensive preparations and … a large body of scientific data” collected so far on ST-002.
Cushing’s syndrome is an umbrella term encompassing medical conditions that are driven by excessively high levels of the hormone cortisol in the body. High cortisol levels lead to a wide variety of Cushing’s symptoms, which may include weight gain, skin issues, and mood changes. One of the most common forms of the syndrome is Cushing’s disease, where excess cortisol levels are caused by a tumor growing in the brain’s pituitary gland.
We look forward to engaging with our investigators to advance this promising therapy.
ST-002, also known as fluasterone, is designed to block the activity of cortisol and related hormones. By blocking cortisol activity, the therapy is expected to help ease symptoms of Cushing’s syndrome.
According to Sterotherapeutics, anti-inflammatory benefits have been seen with ST-002, alongside other positive pharmacological effects.
Constantine Stratakis, MD, PhD, the company’s executive medical director, said this week’s meeting was held to ensure that all “research is conducted with the utmost precision and integrity.”
“We look forward to engaging with our investigators to advance this promising therapy,” Stratakis said.
The U.S. Food and Drug Administration has granted orphan drug designation to ST-002 as a potential Cushing’s treatment. That designation, awarded to treatments for rare diseases, provides developers additional incentives for investing in therapies for conditions affecting fewer than 200,000 people in the U.S.
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