Right Brain Bio, a biotechnology company focused on developing treatments for complex diseases, has announced a manufacturing agreement with Suven Pharmaceuticals for the production of RB-190, its lead drug candidate targeting the root cause of Parkinson's disease. The agreement marks a significant step forward as Right Brain Bio prepares for Phase II clinical trials.
RB-190 represents a novel approach to treating Parkinson's disease, aiming to modify disease progression rather than merely alleviating symptoms. The drug is a repurposed form of metyrosine, developed based on a groundbreaking discovery by Right Brain Bio's Founder and CEO, Dr. Jonathan Sackner-Bernstein.
A New Understanding of Parkinson's Disease Pathology
Dr. Sackner-Bernstein's research revealed that excessive dopamine exposure leads to the neurotoxicity that drives Parkinson's disease progression. This insight challenges conventional understanding of the disease and has led to the development of RB-190 as a potential disease-modifying therapy.
"We are excited to collaborate with Suven Pharma as we move RB-190 toward clinical trials," said Dr. Sackner-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."
Preclinical studies conducted in nine different models of Parkinson's disease have demonstrated RB-190's potential to reverse disease pathology, offering a promising new avenue for patients suffering from this debilitating condition.
Addressing a Growing Public Health Challenge
Parkinson's disease affects over 1 million Americans, making it the second most prevalent neurodegenerative disorder after Alzheimer's disease. With an aging population, cases are expected to double by 2030, underscoring the urgent need for transformative treatments like RB-190.
Current therapeutic options for Parkinson's disease primarily focus on symptom management through dopamine replacement strategies. While these treatments can provide temporary relief, they do not address the underlying disease process or prevent progression. RB-190's approach targets the root cause of neurodegeneration, potentially offering the first therapy capable of reversing disease progression.
Manufacturing Excellence for Clinical Success
Suven Pharmaceuticals brings significant expertise to the partnership, with a legacy spanning over three decades in contract drug development and manufacturing. The company operates a network of US FDA-audited facilities and has completed over 1,000 projects for major global pharmaceutical companies.
"At Suven, we are thrilled to be part of this breakthrough initiative with Right Brain Bio," said Vivek Sharma, Executive Chairman of Suven Pharmaceuticals. "Our team is dedicated to manufacturing the highest-quality API for RB-190, ensuring that this innovative therapy meets global quality and regulatory standards. 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."
Regulatory Progress and Clinical Development
Right Brain Bio has made significant progress on the regulatory front. The FDA has reviewed the scientific and operational foundation for RB-190 and confirmed that the next step is an Investigational New Drug (IND) submission for a Phase II clinical trial. This accelerated development pathway reflects the strength of the preclinical data and the urgent unmet need in Parkinson's disease treatment.
Founded in 2018, Right Brain Bio has pioneered the development of RB-190 using its proprietary "First Principles-Based Gap Analysis" methodology to identify novel therapeutic applications. The company's approach to drug repurposing offers potential advantages in development timelines and safety profiles compared to entirely new molecular entities.
Strategic Partnership in a Competitive Landscape
The partnership comes at a strategic time for both companies. Suven Pharmaceuticals is in the process of amalgamating with Cohance Life Sciences, having secured key regulatory approvals from NSE, BSE, SEBI, and minority shareholders. The merger will create a leading technology-driven CDMO with expanded capabilities in custom synthesis, process R&D, and manufacturing for global innovators.
Suven has also strengthened its technology expertise through strategic acquisitions, including Sapala for oligonucleotides in June 2024 and NJ Bio for ADC technology in December 2024. The company has achieved consolidated revenue of US$315 million while maintaining industry-leading margins over the past five years.
As Right Brain Bio advances RB-190 toward clinical trials, this manufacturing agreement represents a critical milestone in bringing a potentially transformative therapy to Parkinson's disease patients who currently have limited options for disease modification.
