Strekin AG, Basel, Switzerland, a clinical stage biopharmaceutical company, announced that it has successfully closed a Seed C financing round totaling CHF10 million (approximately $10.3 million USD) from private investors. These funds will enable Strekin to conduct a second clinical trial of STR001 as a potential new treatment for acute types of hearing loss, and to pave the way for broader indications.
STR001 is Strekin’s lead drug candidate, according to the company, and is a potent peroxisome proliferator-activated receptor-gamma agonist (PPAR?). STR001 effectively protects auditory hair cells of the inner ear through multiple mechanisms. STR001’s therapeutic properties have reportedly been extensively researched in diverse preclinical models of cochlear hair cell protection and hearing loss, said Strekin.
One international Phase 2 clinical study of STR001 is currently ongoing. The STR001-201 trial tests the ability of intra-tympanic STR001 to prevent hearing loss in patients undergoing cochlear implantation (CI) surgery. Despite advances in cochlear implantation technology, acute loss of residual hearing is a risk of CI surgery. Strekin said STR001 has the potential to prevent this undesired outcome.
The current financing will fund a new Phase 3 trial, RESTORE, and secure Strekin’s corporate needs until early 2019. RESTORE is an international, randomized, placebo-controlled Phase 3 clinical trial of STR001 in patients suffering from a sudden onset sensorineural hearing loss (SSNHL). RESTORE will evaluate STR001 intra-tympanic treatment with and without oral follow-up with STR001 tablets. RESTORE will be conducted in more than 30 centers in Western and Eastern Europe and in the United States.
“With our current Phase 2 trial progressing well in CI patients, we are now pleased to have secured the funding to launch a second clinical trial in sudden sensorineural hearing loss,” said Alexander Bausch, Strekin’s CEO and founder. “Both trials address a clear unmet medical need in patients who have suffered an acute event that may lead to severe, lifelong hearing loss. If successful, the confirmatory nature of both trials, as well as the orphan disease status of the indication, may allow Strekin to bring STR001 to the market. Having received orphan drug designation for STR001 in the treatment of sudden sensorineural hearing loss in Europe earlier this year, is well aligned with this strategy.”