Clinical Trials

Date: 2017-03-01

Type of information: update on patient enrollment

phase: 2

Announcement: update on patient enrollment

Company: Strekin (Switzerland)

Product: STR001 (pioglitazone)

Action mechanism: PPAR agonist. The active principle of STR001 is pioglitazone. In preclinical studies, STR001 provided significant protection of auditory hair cells of the inner ear in models of hearing loss. Hair cells are responsible for converting airborne sound to electrical signals to the brain and are commonly lost or dysfunctional in many types of hearing loss. Strekin has obtained exclusive worldwide rights to a patent covering the use and route of administration of STR001 as a treatment for hearing loss.

Disease: preservation of residual hearing in patients undergoing cochlear implantation surgery

Therapeutic area: Otorhinolaryngology

Country: France, Germany, Italy, Spain

Trial details: 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.

Latest news:

• • On March 1, 2017, Strekin announced the presentation of an update onphase 2 clinical development program for STR001 in the treatment of hearing loss at the Association for Research in Otolaryngology Conference (ARO). 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.
• • On April 27, 2016, Strekin AG announced the launch of a Phase 2 clinical study of its lead drug candidate, STR001, to preserve residual hearing in patients undergoing cochlear implantation (CI) surgery. This large, placebo-controlled, double-blind, phase 2 study is currently recruiting patients in Germany and France. STR001 is administered directly into the middle ear at the time of surgery. Prof Arneborg Ernst (UKB Berlin) is the Clinical Lead Investigator of the trial.

Is general: Yes