Inventage Lab’s multiple sclerosis drug candidate to get orphan drug status

Inventage Lab, a microfluidic drug delivery platform developer, said on Monday that its IVL4002, a recurrence-relieving multiple sclerosis treatment candidate, is scheduled to receive orphan drug designation (ODD) from the Ministry of Food and Drug Safety (MFDS).

IVL4002, an investigational relapsing-remitting multiple sclerosis (RRMS) treatment, maintains stable and effective concentrations suitable for increasing the efficacy of novel indication through a long-acting injection drug platform, IVL-Drug Fluidic, the company said. 

Multiple sclerosis is a rare autoimmune disease caused by damage to the myelin sheath, an insulating material surrounding nerve cells. It occurs in less than one in 20,000 people in Korea. It is a serious disease that usually leads to paralysis and cognitive impairment, and blindness in severe cases.

Although treatments for multiple sclerosis exist, it is difficult to sustain their effectiveness due to serious side effects. Additionally, patients' motor disorders and cognitive impairments increase the difficulty of taking medicine every day, thus lowering the treatment effect.

Accordingly, Inventage Lab will push for IVL4002’s rapid clinical entry and commercialization as it offers increased medication compliance due to the convenience of monthly medication administration, the company said.

Inventage Lab hopes to conduct a phase 1 study of IVL4002 in 2023.

A drug candidate with ODD status can be eligible for application for expedited review,  exemption of some data submission on safety and efficacy, priority marketing authorization upon phase 2 clinical trial completion, four-year market exclusivity, and orphan drug item license validity for 10 years.