The Phase III trial follows the company’s previous Phase I trial, which saw 12 participants dosed with Bemdaneprocel. Credit: Shutterstock / Yuri A

US-based Bayer subsidiary BlueRock Therapeutics has accelerated bemdaneprocel, its investigational cell therapy candidate for Parkinson’s disease, to Phase III trials after a Phase I study saw the treatment was well tolerated.

The Massachusetts company plans to launch its registrational trial, named exPDite-2, in the first half of 2025 following discussions with the US Food and Drug Administration (FDA) after the therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation.

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The expedite-2 study will examine the safety and overall impact of bemdaneprocel compared to a sham surgery control in a study that aims to enrol approximately 102 patients with moderate Parkinson’s disease. In this study the primary endpoint will be change from baseline to week 78, measuring the time at which the treatment can improve motor function without adverse events (AEs) such as dyskinesia.

The Phase III trial follows the company’s previous Phase I trial (NCT04802733), which saw 12 patients dosed with bemdaneprocel meet its primary endpoint of tolerability and secondary endpoints on motor impairments at 24 months post-surgery.

Amit Rakhit, chief development and medical officer at BlueRock Therapeutics, said: “We are thrilled to take this critical step in our development programme towards further investigating a potential new therapeutic option for people living with Parkinson’s disease.

“The exPDite-2 trial is the first registrational Phase III clinical trial for an investigational pluripotent stem cell-derived therapy in Parkinson’s disease and we look forward to working closely with clinical investigators and the Parkinson’s disease community as we initiate this trial.”

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Bemdaneprocel is an investigational cell therapy that acts by inducing dopaminergic neuron progenitor cells, the cells which are lost in Parkinson’s disease.

Currently there are seven drug candidates for Parkinson’s disease in Phase III trials. This is alongside 40 drugs already marketed. Research by GlobalData estimates that the diagnosed prevalent cases of Parkinson’s disease across the seven major markets are projected to grow at an annual growth rate (AGR) of 1.94% between 2023 and 2033. Representing an increase from 2.64 million to 3.15 million in the period.

GlobalData is the parent company of Clinical Trials Arena.

Christian Rommel, global head of research and development at Bayer, added: “With the planned initiation of the Phase III clinical trial, we are committed to bringing bemdaneprocel faster to patients in need. It represents a significant milestone in our efforts to advance our cell and gene therapy pipeline and deliver on our ambition to be an industry leader in this space.”

Elsewhere in the Parkinson’s disease space, Cerevel Therapeutics has reported positive topline results from its Phase III TEMPO-3 clinical trial evaluating a once-a-day dose of tavapadon.