15 September 2019 | News
An international, randomized, placebo-controlled, Phase 3 clinical trial of the investigational drug STR001 in patients following a Sudden Sensorineural Hearing Loss (SSNHL) event
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Strekin AG, a biopharmaceutical company focused on treatments for hearing loss, on 12 Sep 2019, announced that it has successfully completed patient recruitment in the RESTORE study, an international, randomized, placebo-controlled, Phase 3 clinical trial of the investigational drug STR001 in patients following a Sudden Sensorineural Hearing Loss (SSNHL) event. RESTORE is evaluating the ability of STR001 given by intratympanic injection with and without 3-month oral follow-up with STR001 tablets to restore hearing in SSNHL. RESTORE has completed enrollment of the target of 165 patients at approximately 25 clinical centers across 5 European countries. STR001 has been very well tolerated and topline results from RESTORE are anticipated to be released in early 2020.
"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," remarked Alexander Bausch, Chief Executive Officer of Strekin. "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."