Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, September 12 2019 - 16:15
AsiaNet
Strekin AG Announces Completion of Patient Recruitment in the RESTORE Phase 3 Clinical Study of STR001
BASEL, Switzerland, Sept.12, 2019 /PRNewswire-AsiaNet/ --

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."  

About STR001 

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. 

About Strekin

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.

Alexander Bausch, 
CEO, Strekin AG 
Email: Alexander.Bausch@strekin.com

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Source: Strekin
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