Bayer subsidiary BlueRock Therapeutics has reported encouraging 24-month outcomes from the Phase I exPDite clinical study of the bemdaneprocel cell therapy for Parkinson’s disease.
This therapy is said to be currently the most clinically advanced in the US for patients with this condition.
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The open-label, non-randomised, non-controlled trial was conducted across multiple centres.
It enrolled 12 patients with Parkinson’s disease who underwent surgical transplantation of bemdaneprocel into the post-commissural putamen bilaterally.
Two different dose levels were administered, with Cohort A receiving 0.9 million cells per putamen and Cohort B receiving 2.7 million cells per putamen.
Participants were also given a one-year immunosuppression regimen.
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By GlobalDataThe primary endpoint of safety and tolerability was assessed at 12 months, alongside evaluations of cell survival and motor effects.
The results have shown that bemdaneprocel’s safety profile at 24 months was in line with prior data, indicating good tolerance and no adverse events directly related to the therapy.
After discontinuing immunosuppression therapy at 12 months, as per the study protocol, the transplanted cells continued to survive and engraft in the brain, the company noted.
BlueRock Therapeutics chief development and medical officer Amit Rakhit said: “We are very excited to share the 24-month data from the exPDite trial, which shows that bemdaneprocel could be a potentially meaningful treatment option for individuals living with Parkinson’s disease.
“The completion of this study marks an important milestone for bemdaneprocel and sets the stage for the next phase of clinical development.”
Furthermore, secondary clinical endpoints related to motor symptoms showed positive trends from baseline throughout the follow-up period. These trends were more pronounced in the high-dose cohort.
Tools such as the MDS-Unified Parkinson’s Disease Rating Scale Part II and III (MDS-UPDRS Part II & III) and the Hauser PD Diary were used to assess the severity of motor symptoms in Parkinson’s disease.
Bayer’s pharmaceuticals division research and development head Christian Rommel said: “The continued positive results of the exploratory clinical endpoints for bemdaneprocel after 24 months are encouraging and support our commitment to developing innovative therapies that can significantly improve patient lives.”
The latest development comes after the US Food and Drug Administration (FDA) granted clearance for BlueRock Therapeutics’ investigational new drug (IND) application to commence a Phase I/IIa trial of OpCT-001, an investigational iPSC-derived cell therapy to treat primary photoreceptor diseases.
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