VM BioPharma, the US unit of South Korean biopharmaceutical company ViroMed, has secured fast track designation from the US Food and Drug Administration (FDA) for its primary investigational drug VM202.
VM202 is a Phase II gene therapy that can be used to treat patients suffering from amyotrophic lateral sclerosis (ALS).
Also named as Lou Gehrig’s disease, ALS is a neurodegenerative disease that occurs rarely due to unknown causes.
In the case of ALS, the motor neurons required to move muscles in the body are affected.
This results into the paralysation of all muscles, including the neck, tongue and the limbs, in the body of the ALS-affected patient.
According to the company, the data from the Phase I/II trial of VM202 in ALS is expected to be published in the second half of this year.
The primary endpoint of the trial studied the safety and tolerability of VM202, while the secondary endpoints studied the ALS Functional Rating Scale (ALSFRS-r) and other efficacy parameters.
ViroMed new business development head Dr Seungshin Yu said: "We are very pleased to announce that the FDA has granted Fast Track designation for VM202 in the potential treatment of ALS.
"This status underscores the need to expedite potentially new and important treatment options for the ALS community.
"The Fast Track designation, coupled with the recent Orphan Drug designation from the FDA, provides even more momentum in our work to address the urgent and significant unmet medical need that remains in the treatment of people with ALS."
By the end of this year, the company intends to submit investigational new drug (IND) application for Phase II trial to FDA.
Image: Amyotrophic lateral sclerosis. Photo: courtesy of Frank Gaillard / Wikipedia.
