ARA-290

ARA-290 (Cibinetide — EPO Helix-B Surface Peptide)

Evidence & Status

  • Preliminary / Experimental
  • Preliminary

At a Glance

A non-erythropoietic peptide derived from the tissue-protective region of erythropoietin (EPO), engineered to retain EPO's nerve-protective effects without stimulating red blood cell production. Studied in small fiber neuropathy and sarcoidosis-related nerve damage.

Plain English

Researchers study ARA-290 because erythropoietin — best known as the hormone that stimulates red blood cell production — also protects nerve tissue through a separate receptor. Scientists specifically engineered ARA-290 to target only this nerve-protective pathway, avoiding the blood cell stimulation that makes full EPO inappropriate for non-anemia applications. It has been studied in clinical trials for small fiber neuropathy, a painful nerve condition associated with sarcoidosis and other diseases, with promising preliminary results in reducing neuropathic pain.

Overview

ARA-290, also called cibinetide, is an 11-residue synthetic nonerythropoietic peptide modeled on the EPO helix-B surface. Small controlled studies reported symptom and corneal nerve-fiber outcomes in sarcoidosis-associated small-fiber neuropathy, but these findings do not establish broad efficacy across neuropathy causes. Lack of erythropoietic activity does not establish absence of all thrombotic or other risks.

Research Summary

A randomized double-blind pilot in sarcoidosis patients with small-fiber-neuropathy symptoms evaluated 2 mg IV three times weekly for four weeks. A separate blinded placebo-controlled study evaluated daily SC administration for 28 days in sarcoidosis-associated small-nerve-fiber loss and reported symptom and corneal nerve-fiber endpoints. NCT02039687 is a completed 64-participant randomized phase II study with posted results. These limited, population-specific findings do not establish broad efficacy across neuropathy causes.

Research Areas

  • Small fiber neuropathy
  • Sarcoidosis
  • Nerve regeneration
  • EPO tissue-protective pathways
  • Corneal nerve fiber density

Safety & Risks

Serious Risks

  • Long-term safety profile unknown beyond Phase II trial duration
  • Theoretical immune modulation at high doses
  • Insufficient data for chronic use beyond 90 days

Reported Side Effects

  • Short controlled studies reported limited safety data; long-term safety is not established
  • Mild injection site reactions
  • Transient fatigue (uncommon)
United States
Investigational; no FDA approval or orphan-designation statement is made here
United Kingdom
Investigational
Australia
Investigational
Canada
Investigational

Citations & Sources