Risvodetinib is a chronically administered oral drug candidate that targets the underlying biological mechanism of Parkinson’s disease with an intention to halt the disease progression and reverse the functional loss
Risvodetinib is designed to modify the course of Parkinson's disease. (Credit: Milad Fakurian on Unsplash)
US-based Inhibikase Therapeutics has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for risvodetinib (IkT-148009) to treat multiple system atrophy (MSA).
Risvodetinib is a once-daily chronically administered oral drug candidate that targets the underlying biological mechanism of Parkinson’s disease.
The potent, selective small-molecule medication is designed to halt the disease progression and reverse the functional loss.
The company is engaged in the development of protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-associated disorders, and other diseases of the Abelson Tyrosine Kinases.
Inhibikase Therapeutics chief executive Milton Werner said: “We are pleased to receive orphan drug designation for Risvodetinib in MSA underscoring the high unmet medical need in this patient population.
“There are currently no approved symptomatic or disease-modifying therapies for MSA on the market. MSA is an aggressive form of Parkinsonism, leading to death four times faster than a diagnosis of Parkinson’s disease and we believe that Risvodetinib could potentially slow or halt the progression of disease.
“As we look ahead, we are advancing our ongoing animal model studies of Risvodetinib to determine its therapeutic potential to block progression and correct functional loss in MSA.
“These studies will form the basis of our planned Phase 2 clinical study and we look forward to providing further updates on the potential timing of the Phase 2 trial in the coming quarters. We believe proof that Risvodetinib is clinically beneficial in MSA will form a basis for potential success in other forms of Parkinsonism.”
Inhibikase filed two Investigational New Drug (IND) applications in February 2019 for the drug’s clinical development in multiple categories of Parkinson’s patients.
In March this year, the drugmaker secured IND clearance for its planned Phase 2 MSA clinical trials.
Recently, the American firm announced the development of a new tablet formulation of risvodetinib in order to enhance drug exposure and make it easier to use.