Company repurposing anticancer medication RB-190 for Parkinson’s
Right Brain Bio to seek FDA green light to test therapy in Phase 2 trial
Right Brain Bio is repurposing the approved therapy RB-190 as a treatment for Parkinson’s disease — and is now preparing to seek U.S. Food and Drug Administration (FDA) clearance to test the anticancer medication for this indication in a Phase 2 clinical trial.
The company intends to file an application with the FDA asking for a green light to evaluate the therapy’s efficacy in slowing disease progression in Parkinson’s patients. To manufacture RB-190, Right Brain Bio has entered into a collaboration with Suven Pharmaceuticals, a global contract development and manufacturing organization.
“We are excited to collaborate with Suven Pharma as we move RB-190 toward clinical trials,” Jonathan Sackner-Bernstein, MD, founder and CEO of Right Brain, said in a press release in which the company announced the manufacturing agreement with Suven.
Parkinson’s symptoms are caused by the loss of nerve cells that produce dopamine — a chemical messenger — in a part of the brain that controls movement. Research by Sackner-Bernstein has found that vesicles that store dopamine inside nerve cells are also lost. This results in excess free dopamine inside nerve cells, which can be toxic.
While it seems counterintuitive, Sackner-Bernstein suggests that reducing the levels of free dopamine could offer a way to prevent the loss of nerve cells in the brain, easing symptoms of Parkinson’s. With this idea in mind, Sackner-Bernstein’s team trained his sights on metyrosine (sold as Demser and generics), an FDA-approved medication used to treat rapid heartbeat and high blood pressure due to a rare tumor of the adrenal gland called pheochromocytoma.
Right Brain Bio teams up with Suven to manufacture anticancer medication
RB-190, the repurposed form of metyrosine being tested by the company, works by reducing the amount of dopamine and other signaling chemicals produced by the body. Preclinical models of Parkinson’s in lab-grown cells, mice, and rats showed that metyrosine may prevent the death of nerve cells.
According to Vivek Sharma, executive chairman of Suven Pharmaceuticals, “the potential of RB-190 to redefine Parkinson’s treatment is truly inspiring, and we are proud to contribute our expertise in drug manufacturing to support its development.”
Repurposing an already approved medication — which already would have met certain FDA safety standards — can sometimes speed up clinical testing, and also reduce the risk of unexpected side effects in trial participants.
The FDA has reviewed the science behind RB-190 and agreed that the next step is to submit an investigational new drug (IND) application, according to Right Brain Bio. An IND, if cleared, would allow the company to begin a Phase 2 clinical trial evaluating the therapy’s ability to slow disease progression in people with Parkinson’s.
The potential of RB-190 to redefine Parkinson’s treatment is truly inspiring. … At Suven, we are thrilled to be part of this breakthrough initiative with Right Brain Bio.
For Bernstein, “bringing a novel therapy to clinical trials requires manufacturing excellence and stringent regulatory compliance. With Suven’s expertise, cutting-edge facilities, and recent successful FDA review, we are confident in delivering RB-190 at the highest quality standards for our upcoming trials.”
With experience in many projects involving manufacturing, Suven runs a network of FDA-audited facilities and has collaborated with more than 25 major pharmaceutical companies worldwide.
“At Suven, we are thrilled to be part of this breakthrough initiative with Right Brain Bio,” Sharma said. “Our team is dedicated to manufacturing the highest-quality [active pharmaceutical ingredient] for RB-190, ensuring that this innovative therapy meets global quality and regulatory standards.”
About the Author
