New Delhi, Aug 27
A molecule developed in India by Professor D.S. Rawat and his team for the treatment of Parkinson's disease has cleared Phase I of human clinical trials.
The drug discovery is the most challenging process as it requires a lot of money and is time-consuming. Professor Rawat started this research while he was at Delhi University. Now he is serving as Vice Chancellor of Kumaun University, Nainital.
Rawat told IANS, "As per data available when a medicinal chemist synthesizes over 10,000 compounds and five compounds clear clinical trials and finally one comes to the market as a drug and it takes over 16-17 years with average cost of 450 million US dollars."
Last year a report was published disclosing the entry of Phase 1 clinical trials of a molecule (ATH 399A) originally synthesized by a team of researchers led by Rawat. This collaborative work started in 2012, when Prof Kwang-Soo Kim from McLean Hospital of America contacted Prof Rawat for possible collaboration to develop a molecule for the treatment of Parkinson's disease. Since then both the teams worked tirelessly and screened more than 700 new compounds made by the team of researchers from Delhi University.
Rawat informed that Parkinson's is one of the diseases for which there is no treatment available till date. Presently, medication initially slows down the progress of the disease but as the disease progresses this treatment becomes useless. So scientists across the world are trying to develop a drug which can cure Parkinson's disease.
With this aim, a MoU was signed between Delhi University and McLean Hospital in 2012 and they tested over 700 new compounds for potential as a drug for Parkinson's treatment. In 2021, Delhi University and McLean Hospital transferred this technology to NurrOn pharmaceuticals to develop this molecule as a drug for Parkinson's treatment. Later HanAll Biopharma, and Daewoong Pharmaceutical joined hands with NurrOn Pharmaceuticals and last year started dosing the first human healthy participant in this Phase-1 clinical trial.
The Phase-1 study is designed to assess the safety, tolerability, pharmacokinetics, and food effect of ATH399A when orally administered to healthy participants aged 18 to 80 years.
The study encompasses both a single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The initial results from the Phase 1 clinical trial have now been made available and it has cleared the Phase I trials, making it a perfect molecule to treat Parkinson's disease. Next year the Phase II trials will begin where the Parkinson's disease patient will be treated with this molecule.
The Michael J. Fox Foundation for Parkinson's Research supports the Phase 1 clinical trial of ATH399A.
In animal model studies this molecule showed that it activates the crucial Nurr1 enzyme to stop the death of the dopamine neuron and it also stops the aggregation of alpha synuclein protein, so it has two distinct mechanisms. This work was published by Nature Communications last year. This discovery is considered to be one of the most important in recent times for the treatment of an incurable disease, Rawat added.
Rawat said that the progress of this project has slowed as we can't get new PhD students as per a rule of Delhi University.