Bayer AG and its subsidiary, BlueRock Therapeutics LP, have announced positive topline results from an early-stage study of an experimental Parkinson’s disease stem cell therapy.
In the phase 1 study of bemdaneprocel, the treatment was shown to be well-tolerated in all 12 patients involved in the study, and transplanted cells grew as intended in the patients’ brains at one-year post-transplant.
The companies said that, based on these positive results, planning is already underway for a phase 2 study that is expected to begin enrolling patients in the first half of 2024.
There is no cure for Parkinson’s disease, a progressive and chronic neurological disorder that affects an estimated ten million people worldwide.
The disease is caused by nerve cell damage in the brain, which leads to decreased levels of dopamine. The loss of these dopaminergic neurons results in a progressive decline of motor function and symptoms such as tremors, muscle rigidity, slowness of movement and difficulty with balance.
Bemdaneprocel is comprised of dopamine-producing neurons derived from pluripotent stem cells that, when transplanted into the braina of patients with Parkinson’s disease, have the potential to reform neural networks and restore motor and non-motor function.
Senior vice president and head of development at BlueRock, Ahmed Enayetallah, said: “We are on a mission to harness the power of cell therapy with the aim to help people with Parkinson’s disease regain control of their lives by restoring the functions that they have lost to this disease.
“The safety profile of bemdaneprocel was encouraging along with early evidence of cell survival and engraftment, marking a very important step in the development of a potential new therapy for patients with this disease.”
Christian Rommel, member of the executive committee of Bayer’s pharmaceuticals division and head of research and development, added: “The positive outcome of our first cell therapy clinical trial for Parkinson’s is encouraging not only for the bemdaneprocel development programme but also our entire pluripotent stem cell-based platform and warrants further investigation in larger groups of patients.”
Bayer acquired US-based BlueRock in 2019 in a bid to boost its cell therapy business, with the president of Bayer AG’s pharmaceutical division, Stefan Oelrich, describing the deal as a “major milestone” on the company’s path towards a “leading position” in cell therapy.
“Ultimately, we are joining forces to deliver new treatment options for medical needs that are still unmet today,” Oelrich said.