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.
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