Phase 2b Trial of Pirepemat, to Prevent Falls, Approved in Sweden
IRLAB has received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2b trial for its investigational medication, pirepemat (previously known as IRL752), which is intended to treat impaired balance and prevent falls in patients with Parkinson’s disease.
“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,” Nicholas Waters, CEO at IRLAB, said in a press release.
IRLAB used the Voluntary Harmonization Procedure (VHP) — which allows a clinical trial application to be assessed in multiple European countries — to submit the application, with the intention of applying to other European countries as well. The Swedish MPA, acting as the reference country, is already joined by the Polish and Spanish regulatory authorities.
Approvals from regulatory authorities in other participating countries and from ethics committees are expected, allowing patient recruitment for the Phase 2b trial to start in the first quarter of 2022, with continuation expected for 18 months.
“After receiving advice from regulatory authorities and in collaboration with external experts, we have designed a study to support the continued development of pirepemat,” Waters added.
In advanced stages of Parkinson’s, there is a progressive decline in cognitive functions, with parallel impairment of motor functions. That decline is linked to postural dysfunction (impaired balance) and increased risk of falling.
Pirepemat is a small molecule that can enhance communications between nerve cells in the frontal cortex, a major brain area that controls cognitive functions. It does so by increasing the availability of two chemical messengers (neurotransmitters) — norepinephrine and dopamine — which are necessary for nerve cells to communicate and whose levels are reduced in those with Parkinson’s. It also activates specific genes involved in nerve cell communication.
The medication has already demonstrated good safety and tolerability profiles in healthy volunteers in a Phase 1 trial and in Parkinson’s patients with dementia in a Phase 2a trial. Results from the Phase 2a trial (2017-001673-17) of Parkinson’s patients showed an improvement in postural stability and reduced falls, as well as a lessening in apathy and cognitive impairment.
“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,” said Joakim Tedroff, MD, PhD, chief medical officer at IRLAB.