Policy & Regulation
ImmunAbs Gains US FDA Approval for a Phase 1 Clinical Trial
5 August 2022 - - South Korea-based drug discovery company ImmunAbs Inc has received US FDA approval for a Phase 1 clinical trial and that it is now ready to initiate a phase 1 clinical trial in the United States, the company said.

ImmunAbs is developing IM-101, a monoclonal antibody targeting complements that play essential roles in the immune system but, when out of regulation, cause various autoimmune diseases, including but not limited to paroxysmal nocturnal hemoglobinuria.

The complement inhibitors drug market showed its growth potential by achieving an average annual growth rate of 20.7% and a market size of USD 5.1bn in 2020 and is expected to grow to USD 19bn by 2027.

Paroxysmal nocturnal hemoglobinuria is one example of complement-mediated autoimmune diseases where the membrane proteins protecting the red blood cells from complement activation are lost due to mutations, which results in red blood cells being destructed by the complements.

Due to insufficient inhibition of complements shown by currently approved complement inhibitors, Soliris and Ultomiris, patients who receive these drugs still suffer from the residual symptoms of PNH, which include anaemia, fatigue, and decreased productivity at work.

ImmunAbs' new complement therapeutic IM-101 targets the safest and most potent component of the complement system, complement C5.

IM-101 has been shown to completely inhibit complement activation, and thus is expected to alleviate the symptoms that persist with the standard of care.

ImmunAbs said it will initiate a phase 2a clinical trial in the United States in 2024.

ImmunAbs was established in 2017. Currently, ImmunAbs has several antibody therapeutics in global standard development for autoimmune diseases, diabetic retinopathy, and metabolic syndrome.

ImmunAbs successfully raised KRW 18.1 bn from Seed to series A funding in 2021 and got a non-clinical study national grant for developing IM-101 from Korea Drug Development Fund in November last year.