• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Arrien Pharmaceuticals initiated phase I trials of ARN-6039 for multiple sclerosis

Arrien Pharmaceuticals initiated phase I trials of ARN-6039 for multiple sclerosis

June 10, 2016
CenterWatch Staff

Arrien Pharmaceuticals 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.

“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, M.D., professor, chief of division of Neuroimmunology at the 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.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing