Onyx Completes API project with Neuronascent

UK-based CMO Onyx Scientific has completed an API development and manufacturing project with US-based Neuronascent, Inc, a company that develops orally available neurogenic and neurorestorative therapeutics that target Parkinson’s disease, Down syndrome, Alzheimer’s disease and post-traumatic stress disorder.

Neuronascent’s lead candidate is NNI-362, which is aimed at Alzheimer’s disease and Parkinson’s disease as well as other neurodegenerative disorders.

Onyx Scientific assisted the Maryland-headquartered firm with the process development and production of a 1 kg batch of API that was used in the pre-IND submission along with supporting initial stability data.

Judith Kelleher-Andersson, Ph.D., founder, president and CEO at Neuronascent, said: “Onyx Scientific has the ability to synthesise a 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 who 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 clinical trials, scaling up to large-scale API production.

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.

“We look forward to potentially having the opportunity to work with them on the next phase of the project, which 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 programmes and is then able to scale-up, tech transfer and increase project efficiency using its commercial manufacturing sites in India.

Onyx Scientific, www.onyx-scientific.com.