Strekin AG Presents Update on Phase 2 Development of STR001 and New Preclinical Data in Hearing Loss

Strekin AG, a privately held clinical-stage biopharmaceutical company, announced the presentation of new preclinical data and an update on Strekin’s Phase 2 clinical development program for STR001 in the treatment of hearing loss at the Association for Research in Otolaryngology Conference (ARO), Baltimore, USA.

STR001-201 is a Phase 2 clinical trial of STR001 intratympanic injection for the treatment of Sudden Sensorineural Hearing Loss (SSHL) caused by Cochlear Implantation (CI) surgery. An undesired outcome of CI is the loss of residual low-frequency hearing due to electrode insertion trauma. STR001-201 is an international, multicenter, randomized, placebo-controlled trial evaluating the efficacy, safety and tolerability of STR001-IT intratympanic injection in 110 patients undergoing CI surgery. As of 10 Feb 2017, the STR001-201 trial had enrolled 50 patients in four countries (Germany, France, Spain and Italy). STR001-IT treatment has been very well tolerated with no adverse events of concern identified. Top-line clinical trial results are expected in the 4th quarter of 2017.

In a poster presentation (#PS792) entitled "Peroxisome proliferator activated receptor -gamma and -alpha agonists protect auditory hair cells from gentamicin-induced oxidative stress and apoptosis”, researchers observed that the PPAR agonist pioglitazone, the active ingredient in STR001, was highly effective in preventing damage to the sensory hair cells of the inner ear. The research was led by Daniel Bodmer, MD, PhD, and Chairman of the Department of Otolaryngology Head & Neck Surgery at the University Hospital of Basel.

Dr. Bodmer’s analysis was performed in a model in hearing research in which the organ of Corti, the structure containing auditory hair and sensory cells, is studied in tissue culture. Treatment of cultures with gentamicin, an antibiotic that often leads to hearing loss in humans, caused destruction of 50% of hair cells which was almost completely prevented by STR001. Further analysis showed that gentamicin induced the production of oxygen free radicals, promoted lipid oxidation, and activated the cell death pathway (apoptosis) in hair cells, all of which were prevented by STR001.

These data, together with the data from Dr. Bodmer’s group, suggest that STR001 has the potential to be a new and differentiated therapy for many types of hearing loss through favorable effects on multiple pathways.

In a second presentation (#PS159) entitled “Intra-tympanic Administration of Pioglitazone, a Peroxisome Proliferator-Activated Receptor Gamma Agonist, Protects from Noise-Induced Hearing Loss” Dr. Anna-Rita Fetoni and her colleagues from the Catholic University of Rome, showed that a single intratympanic injection of STR001-IT was highly protective in a rodent model of noise-induced hearing loss. The protection afforded by STR001 was accompanied by a strong reduction in markers of oxidative stress in auditory hair cells and neural elements in the cochlea. This protection was even partially maintained when injecting STR001IT 48 hours after the noise challenge which based on our knowledge was never achieved up to now.

About Strekin

Strekin is a privately held clinical-stage biopharmaceutical company in Basel. Strekin is led by an experienced team in research and successful clinical development. Strekin has secured funding to complete the Phase 2 study of STR001 and to launch further clinical development with the support of investors and partners.

About Hearing Loss

According to the World Health Organization, 642 million people around the world including 181 million children suffer from disabling hearing loss. Daily activities that most people take for granted, like having a conversation, enjoying music, and advancing in the workplace, are difficult or impossible for individuals suffering from hearing loss. With no approved pharmaceutical therapies available today, there is urgency to develop effective treatments.