Arrien Pharmaceuticals has initiated Phase 1 clinical trials of their first agent, ARN-6039, a molecule that targets a specific subset of immune cells called T helper 17 (Th17), for the potential treatment of patients with relapsing, remitting, and progressive multiple sclerosis (MS).
A growing body of evidence has suggested a pathogenic role for Th17 in several autoimmune diseases, including MS, through the production of pro-inflammatory molecules that enable the chronic inflammation.
ARN-6039, a drug discovered through Arrien’s pipeline of clinical drug candidates, is an inverse agonist of ROR-γt, a transcription factor that is essential for Th17 differentiation.
“We are pleased to broaden Arrien Pharmaceuticals’ pipeline of clinical drug candidates with the advancement of ARN-6039 into clinical Phase I. ARN-6039 is one example of how we have applied our novel platform to create therapeutics that represent new treatment options,” said Arrien co-founder and CSO Hariprasad Vankayalapati, in a press release.
The Phase 1 program, which marks the milestone of Arrien into becoming a clinical stage organization, will be conducted under an Investigational New Drug application approved by the U. S. Food and Drug Administration (FDA). The randomized, single-center, double-blind, placebo controlled study will enroll 50 healthy volunteers.
“The exceptional performance of the development team at Arrien Pharmaceuticals has demonstrated the company’s ability to initiate clinical trials for our agent within 16 months of our Series A funding,” said Rajendra P. Appalaneni, Arrien co-founder and CEO. “Clearly our focus in the ARN-6039 clinical program will be to provide a meaningful candidate that differentiates current therapeutics for late stage MS patients with this potential first-in-class small molecule.”
The company expects that the Phase 1 trial results will move ARN-6039 into a Phase 2 trial by the end of the year, when the therapy will be tested in MS patients.