InventageLab Designated as Rare Drug by MFDS for Multiple Sclerosis Treatment

[Asia Economy Reporter Jang Hyowon] InventiGELab (CEO Kim Juhee), a company specializing in microsphere long-acting injectable drugs and LNP manufacturing platforms, announced on the 28th that its relapse-remitting multiple sclerosis treatment pipeline IVL4002 has received notification from the Ministry of Food and Drug Safety regarding its designation and upcoming announcement as a rare drug in the development stage.

The IVL4002 pipeline for treating multiple sclerosis (RRMS) is an innovative new drug pipeline independently discovered by InventiGELab through a drug repositioning strategy. Using InventiGELab’s proprietary long-acting injectable platform IVL-DrugFluidic®, it maintains a stable effective concentration suitable for new indications and induces enhanced efficacy.

Multiple sclerosis is a rare disease with fewer than 20,000 patients domestically. It is an autoimmune disease caused by damage or loss of myelin, the insulating substance surrounding nerve cells in the central nervous system. It causes paralysis, cognitive dysfunction, and in severe cases, blindness, severely impairing patients’ quality of life.

Although some treatments exist for multiple sclerosis, maintaining drug efficacy is difficult and there is a risk of serious side effects. Additionally, patients with multiple sclerosis face challenges in daily medication adherence due to factors such as motor and cognitive impairments, which reduces treatment effectiveness.

To address these unmet medical needs, InventiGELab plans to accelerate clinical entry and commercialization of IVL4002. Based on excellent efficacy and safety, IVL4002 maximizes convenience with once-monthly dosing, improving medication adherence and contributing to multiple sclerosis treatment. Currently, the clinical phase 1 trial application (IND) preparation is complete, aiming to proceed with clinical trials in 2023.

Kim Juhee, CEO of InventiGELab, stated, “We will do our best to successfully complete the clinical trials of IVL4002 and provide treatment to patients suffering from multiple sclerosis.”

Meanwhile, designation as a rare drug in the development stage by the Ministry of Food and Drug Safety provides benefits such as ▲ eligibility for expedited review of marketing authorization applications ▲ exemption from submitting some safety and efficacy data when applying for marketing authorization ▲ priority approval upon completion of phase 2 clinical trials ▲ four years of exclusive marketing rights ▲ and a 10-year validity period for rare drug marketing authorization.