Arrien Pharmaceuticals announced that it has initiated Phase I Clinical trials on their first agent, ARN-6039, which is being developed for the potential treatment of relapse, remitting, and progressive multiple sclerosis (MS), an autoimmune neuroinflammatory demyelinating disease.
Arrien Pharmaceuticals is conducting the Phase I program under an Investigational New Drug (IND) application recently permitted by the FDA. The study is a single-center, randomized, double-blind placebo-controlled safety, tolerability, and pharmacokinetic (PK) study of single ascending oral doses of ARN-6039 in healthy adult subjects.
ARN-6039 is an inverse agonist of ROR-γt that selectively targets the IL-17/TH17 axis and was discovered through Arrien Pharmaceuticals’ fragment-based FIELDS proprietary technology. “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 Hariprasad Vankayalapati, Ph.D., Founder/CSO of Arrien Pharmaceuticals.
“Recent clinical success of IL-17/TH17/ROR targeting agents and oral dosage form, brain-uptake, excellent safety, and efficacy characteristics in models systems, are important aspects of ARN-6039 as potentially innovative new therapy for the treatment of multiple sclerosis,” said John W. Rose, MD, Professor, Chief of Division of Neuroimmunology at University of Utah School of Medicine and SAB member of Arrien Pharmaceuticals.
The progress of ARN-6039 into Phase I development marks the milestone of Arrien Pharmaceuticals into a clinical stage organization. “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, Co-founder/Board of Director. “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 Phase I program planned to enroll 50 healthy human subjects, and we hope to move this program through Phase II proof of efficacy studies in MS patients towards the end of the year. In addition, we will be investigating ARN-6039 in other immune-mediated disorders such as psoriasis in order to fully exploit its therapeutic potential.