Phase 2b trial of pirepemat enrolling patients at 38 clinical sites

Pirepemat is IRLAB Therapeutics’ potential therapy for impaired balance, fall prevention

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Enrollment is now open across all 38 clinical sites in the Phase 2b trial testing pirepemat  (previously known as IRL752), IRLAB Therapeutics’ investigational therapy intended to treat impaired balance and prevent falls in patients with Parkinson’s disease.

The Phase 2b trial (NCT05258071) is recruiting Parkinson’s patients, ages 55 to 85 with at least a three-month history of frequent falls, across France, Germany, Poland, the Netherlands, Spain, and Sweden. Recruitment is scheduled to be complete by year’s end, with top-line results expected in the first half of 2024.

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“We are making good progress with the Phase IIb study of pirepemat and predict a steady recruitment pace over the coming period as the study is now fully up and running,” Joakim Tedroff, chief medical officer of IRLAB, said in a press release.

“I am particularly pleased to have [Professor] Bastiaan Bloem, one of the world’s leading experts on impaired balance and falls in Parkinson’s disease and investigator in our study, start recruitment at the recently activated site in the Netherlands. He is a prominent voice in the Parkinson’s space with a deep commitment to finding a solution to the problem with falls in people living with Parkinson’s disease,” he added.

Participants will be assigned randomly to one of two doses (low or high) of pirepemat or a placebo, as an oral add-on therapy administered three times a day for 12 weeks (about three months).

Study goals

The study’s main goal is to assess changes in fall frequency with pirepemat compared to the placebo. Additional goals include changes in postural dysfunction (impaired balance), cognitive function, motor symptoms, safety and tolerability.

In advanced stages of Parkinson’s, there is a both a progressive decline in cognitive functions and an impairment of motor functions. That decline is linked to postural dysfunction and increased risk of falling.

“Falls are a significant consequence of Parkinson’s disease that has severe complications of which fractures, impaired mobility, and reduced quality of life are the most burdensome,”said Nicholas Waters, executive vice president and head of research and development at IRLAB.

Pirepemat is a small molecule designed to boost communications between nerve cells in the frontal cortex, a major brain area that controls cognitive functions. This is achieved by increasing the availability of norepinephrine and dopamine, two chemical messengers (neurotransmitters) necessary for nerve cells to communicate, whose levels are decreased in Parkinson’s patients. It also activates specific genes involved in nerve cell communication.

“There are no available treatments at present, despite the great medical need with nearly half of all people living with Parkinson’s disease falling recurrently. We believe pirepemat has the potential to make a real difference in the lives of people living with Parkinson’s disease and their families,” Waters said.