Strekin AG Announces Completion of Patient Recruitment in the RESTORE Phase 3 Clinical Study of STR001PR Newswire | Basel | Updated: 12-09-2019 11:45 IST | Created: 12-09-2019 11:45 IST
Strekin AG (www.strekin.com), a biopharmaceutical company focused on treatments for hearing loss, announced today 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."
STR001 is a small molecule agonist of the Peroxisome Proliferator Activated Receptor gamma (PPAR-g), which plays multiple beneficial roles in inflammation, oxidative stress, and cellular metabolism. Preclinical data published by Strekin and its collaborators demonstrated that STR001 effectively protects hearing in animal models by blocking oxidative stress and reducing activation of inflammatory signaling in the cochlea. Animal efficacy data were published in October 2018 in the journal Frontiers in Pharmacology and are available on an open access basis at the following: (https://doi.org/10.3389/fphar.2018.01103).
About Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL) is an acute loss of hearing caused by damage to the sound-sensing hair cells of the inner ear. SSHNL may be caused by surgery, acoustic trauma, or sudden deafness, a phenomenon in which hearing loss occurs without obvious cause. Further symptoms may include ringing in the ears (tinnitus) and dizziness (vertigo). Sudden hearing loss is a medical emergency. Individuals who perceive a sudden change in their hearing are recommended to contact their health care provider without delay. Hearing loss makes daily activities most people take for granted, like having a conversation, enjoying music, and communicating effectively in the work environment, difficult or impossible. There are currently no approved drugs available for the treatment of SSNHL.
Strekin AG (www.strekin.com) is a Swiss-based biopharmaceutical company advancing therapeutics for improved patient benefit in diseases with high unmet need. Strekin is led by a team of experts with extensive experience in successful discovery, development, and commercialization of new drugs. Strekin is privately funded by a broad base of investors.
CEO, Strekin AG