Strekin AG, a biopharmaceutical company focused on treatments for hearing loss, has successfully completed patient recruitment in its study called Restore.
Restore is an international, randomized, placebo-controlled, Phase 3 clinical trial of the investigational drug STR001 in patients following a Sudden Sensorineural Hearing Loss (SSNHL), explained Strekin.
The study is testing the ability of STR001 given by intratympanic injection with and without 3-month oral follow-up with STR001 tablets to restore hearing in SSNHL. Strekin said it enrolled 165 patients at 25 clinical centers across 5 European countries. STR001 has been very well tolerated and topline results from the study are expected to be released in 2020, Strekin said.
Alexander Bausch, Chief Executive Officer of Strekin said if the study is successful, the data, 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.