Newron and Zambon to collaborate on Parkinson’s dyskinesia drug trial

pharmafile | March 15, 2021 | News story | Sales and Marketing Newron Pharmaceuticals, Parkinson's, Zambon 

Newron Pharmaceuticals and its partner Zambon have announced an agreement for a potentially pivotal study to evaluate the efficacy of safinamide in Parkinson’s disease patients with levodopa-induced dyskinesia (PD LID).

Newron is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, and Zambon is an international pharmaceutical company dedicated to the central nervous system therapeutic area.

Parkinson’s disease affects an estimated seven to ten million patients worldwide. More than 40% of Parkinson’s patients experience PD LID, involuntary, non-rhythmic, and often painful movements during waking hours that are purposeless and unpredictable.

Dyskinesia can interfere with people’s daily living, resulting in functional impairment and disability. Currently, only one drug has ever received marketing authorisation for PD LID in the US.

Under the agreement, Newron will sponsor the study and be responsible for its development and execution, as well as leading on all related regulatory interactions. Newron and Zambon will evenly share the cost of the study.

The double-blind, placebo-controlled study is intended to be conducted in the US, Europe, Asia, and Australia, with the aim of a label extension for safinamide in key markets. Safinamide has previously been approved for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa in 20 markets, including the EU, Switzerland, the UK, the US, Canada, and Australia.

Ravi Anand, CMO of Newron, said: “Previous pre-clinical and clinical studies have provided preliminary evidence of the efficacy of safinamide in reducing dyskinesia.

We will be working with international clinical experts and regulatory authorities to finalise the design of a global trial to demonstrate the benefits of safinamide on dyskinesia in patients with PD.”

 Paola Castellani, CMO and R&D Head of Zambon, added: “Since 2015, thousands of Parkinson’s disease patients around the world have benefited from safinamide’s safe and efficacious profile and the subsequent improvement in their motor fluctuations.

“We look forward to working closely with Newron to potentially provide a new treatment option for those living with PD LID, an area of huge medical need.”

Darcy Jimenez

Related Content

gaitQ awarded NIHR grant for Parkinson’s wearable tech

The UK’s National Institute for Health Research (NIHR) has awarded a £135,000 grant to gaitQ, …


AbbVie funds Mitokinin’s Parkinson’s research with option to buy

AbbVie has landed an option to buy neurodegenerative disease-focused biotech Mitokinin following completion of investigational …


New trial to test if cancer drug can effectively treat hallucinations in Parkinson’s patients

A new study is set to go ahead that will test if ondansetron is safe …

Latest content