Genetic Leap, a clinical stage, AI-native biotech company involved in RNA genetic therapeutics, announced on Wednesday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GL-IL2-138, a small-molecule modulator of natural interleukin-2 (IL-2).

According to Genetic Leap, IL-2 is a pleiotropic cytokine that regulates the careful homeostatic balance between immune tolerance and activation.

The drug will now be tested in a randomised, double-blind, placebo-controlled phase 1 clinical trial to evaluate its tolerability, pharmacokinetics and pharmacodynamics in humans.