IRLAB obtains regulatory approval to conduct Phase IIb study with pirepemat – one step closer to improving balance and reducing fall injuries for people living with Parkinson’s disease

December 21, 2021

IRLAB (Nasdaq Stockholm: IRLAB A) IRLAB receives regulatory approval from the Swedish MPA for conducting a Phase IIb study with the investigational drug candidate pirepemat. Following approvals from regulatory authorities in additional participating countries and from ethics committees, patient recruitment will start in Q1, 2022. Recruitment is expected to continue for 18 months.

IRLAB (Nasdaq Stockholm: IRLAB A) IRLAB receives regulatory approval from the Swedish MPA for conducting a Phase IIb study with the investigational drug candidate pirepemat. Following approvals from regulatory authorities in additional participating countries and from ethics committees, patient recruitment will start in Q1, 2022. Recruitment is expected to continue for 18 months.

The application to conduct the Phase IIb study was filed using the Voluntary Harmonization Procedure (VHP). The VHP makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries. In addition to the Swedish MPA, which acts as the reference country, Polish and Spanish regulatory authorities are participating. IRLAB is also applying to regulatory authorities and ethics committees in other selected European countries.

“Pirepemat has potential to be the first treatment in a new class of drugs designed to improve balance and reduce fall injuries in people living with Parkinson’s disease,” said Nicholas Waters, CEO at IRLAB. “After receiving advice from regulatory authorities and in collaboration with external experts, we have designed a study to support the continued development of pirepemat, for which we have now received regulatory approval.”

“Treating impaired balance and reducing risk for falls is a top priority in the battle to fight the complications of Parkinson’s disease, as today these are the most troubling consequences of living with Parkinson’s, leading to reduced quality of life.” added Joakim Tedroff, CMO at IRLAB.