Phase 2b trial with Pirepemat, to prevent Parkinson’s fall, OK in Sweden
IRLAB has received approval from the Medical Products Agency to carry out a phase 2b trial for its trial drug, pirepemat (formerly known as IRL752), which is intended to treat impaired balance and prevent falls in patients with Parkinson’s disease.
“Pirepemat has the potential to be the first treatment in a new class of drugs designed to improve the balance and reduce fall injuries in people living with Parkinson’s disease,” said Nicholas Waters, CEO of IRLAB, in a press release. press release.
IRLAB used the voluntary harmonization procedure (VHP) – which makes it possible to assess an application for clinical trials in several European countries – to submit the application, with the intention of also applying to other European countries. The Swedish Medicines Agency, which acts as a reference country, has already joined the Polish and Spanish regulatory authorities.
Approvals from regulatory authorities in other participating countries and from ethics committees are expected, which means that patient recruitment for the Phase 2b study can start during the first quarter of 2022, with a continuation expected for 18 months.
“After receiving advice from regulators and in collaboration with external experts, we have designed a study to support the continued development of the pierepemat,” Waters added.
In advanced stages of Parkinson’s, there is a progressive decline in cognitive functions, with parallel impairments of motor functions. That decline is linked to postural dysfunction (impaired balance) and increased risk of falling.
Pirepemat is a small molecule that can improve the communication between nerve cells in the frontal cortex, a large area in the brain that controls cognitive functions. It does this 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 people with Parkinson’s. It also activates specific genes involved in nerve cell communication.
The drug has already shown good safety and tolerability profiles in healthy volunteers in a phase 1 study and in Parkinson’s patients with dementia in a phase 2a study. Results from the phase 2a study (2017-001673-17) of Parkinson’s patients showed an improvement in postural stability and decreased cases, as well as a decrease in apathy and cognitive impairment.
“Treating impaired balance and reducing the risk of falls is a top priority in the fight to combat the complications of Parkinson’s disease, as these are today the most worrying consequences of living with Parkinson’s, leading to reduced quality of life,” says Joakim Tedroff, MD . , PhD, Medical Director at IRLAB.