Dutch pharmaceutical firm reports safety test milestone in trial of hair cell regeneration drug

In collaboration with University College London (UCL) and UCL hospitals, the Amsterdam-based pharmaceutical is leading a consortium, REGAIN—backed by the European Union’s Horizon 2020 R&D project—and has recently run its Phase I multiple ascending dose, open-label safety study of the Notch Inhibitor LY3056480 in 15 patients with mild to moderate sensorineural hearing loss.

The trial showed injections (3 administrations, one week apart) at the highest dose of 250 micrograms of LY3056480 was safe and well tolerated, with no safety issues being reported. This is an early-stage result, but a promising one for Audion Therapeutics’ CEO Rolf Jan Rutten, who commented: “These positive Phase I results are an important milestone for Audion’s lead program addressing the growing, global need for treatment options for hearing loss.”

There are currently no clinically available drug treatments that protect, halt the progression of hearing loss, or restore hearing, with World Health Organisation projections suggesting that, without successful action, 630 million people will have hearing loss by the year 2030, and over 900 million by 2050.

Audion’s lead programme seeks an effective drug therapy for sensorineural hearing loss caused by the loss of inner ear hair cells. Larger studies are already under way, as is recruitment for Phase II trials.

Source: B3C Newswire