RESTORE clinical trial of STR001 : Swiss biopharma company Strekin has wrapped up patient enrollment in a phase 3 study, called RESTORE, for evaluating its small molecule STR001 in patients after a sudden sensorineural hearing loss (SSNHL) event.
The late-stage trial is a global, randomized, placebo-controlled study, which will feature 165 patients at nearly 25 clinical centers in five European countries.
The RESTORE clinical trial will study the ability of STR001 administered through intratympanic injection with and without a three-month oral follow-up with the investigational tablets to restore hearing in SSNHL.
According to Strekin, STR001 has been very well tolerated and expects to release topline results from the RESTORE clinical trial in early 2020.
Commenting on the RESTORE clinical trial of STR001, Alexander Bausch – CEO of Strekin, said: “We are pleased to have completed patient enrollment in the Phase 3 RESTORE clinical trial which is designed to evaluate the ability of STR001 activity to reverse hearing loss following a SSNHL event.
“The RESTORE trial tests the ability of STR001 to address a clear unmet medical need in patients who have suffered severe hearing loss that may lead to a debilitating life-long handicap. If successful, the data provided by RESTORE, along with the orphan drug status of STR001 for SSNHL in the EU, may enable STR001 to become the first approved treatment for SSNHL patients.”
STR001 is an agonist of the Peroxisome Proliferator Activated Receptor gamma (PPAR-g), which has various beneficial roles in inflammation, cellular metabolism, and oxidative stress. Preclinical data published by the Swiss biopharma company and its collaborators showed that the PPAR-g agonist protects hearing in animal models effectively by preventing oxidative stress and by bringing down activation levels of inflammatory signaling in the cochlea.
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