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Onyx Completes API Project with US Drug Developer
UK-based contract research organisation Onyx Scientific has completed a development and API manufacturing project with US-based Neuronascent, Inc to support the company with its focus on neurologic disorders.
Neuronascent develops orally available, novel neurogenic and neurorestorative therapeutics that target Parkinson’s disease, Down syndrome, Alzheimer’s disease and post-traumatic stress disorder.
Onyx Scientific assisted the Maryland headquartered firm with the process development and production of a 1kg batch of API that was used in the pre-IND submission along with supporting with initial stability data.
Neuronascent’s lead candidate is NNI-362, which is aimed at Alzheimer’s and Parkinson’s disease and other neurodegenerative disorders.
Judith Kelleher-Andersson, Ph.D., founder, president and chief executive officer at Neuronascent said: “Onyx Scientific has the ability to synthesize high quality API, while still taking into account the time and financial concerns of a small biotech company.
“We have had a very positive experience in dealing with the entire Onyx Scientific team and they have played an important role in moving our Alzheimer’s disease project forward.”
With MHRA and FDA facilities in the UK and India, Ipca Laboratories owned Onyx Scientific assists companies from medicinal chemistry and preclinical through Phase I-III, scaling-up to large scale API production.
The CMO has recently enhanced its presence in the US by adding local representation to support west coast clients, which complements the firm’s existing presence on the east coast.
Denise Bowser, commercial director at Onyx Scientific, said: “We thoroughly enjoyed working with the team at Neuronascent and were able to deliver their project on time despite a pretty tight deadline.
“Early stage development and small scale manufacture of API has been our sweet spot for many years but we continue to improve to ensure we are meeting the needs of our clients across the world who are dealing with increased pressure to develop new products quicker than ever.
“Having been able to assist Neuronascent in this initial non-GMP project, we look forward to potentially having the opportunity to work with them on the next phase of the project that would involve the GMP production of API to support clinical trials.”
Onyx Scientific’s UK-based labs deal with challenging chemistry to deliver early stage programs and is then able to scale-up, tech transfer and increase project efficiency using its commercial manufacturing sites in India.