ARA-290 increased tiny nerve fibers in a 28-day trial
In 64 people with sarcoidosis-related nerve damage, one of three doses of cibinetide increased nerve fibers in the cornea compared with placebo.
The study at a glance
- Who took part
- 64 people with sarcoidosis, small nerve fiber loss and nerve pain
- How it was tested
- Cibinetide at one of three doses or placebo for 28 days; randomized phase 2b
- Main measure
- Corneal nerve fiber area, seen with a special eye microscope
- Result
- Significant only in the middle-dose group: +697 µm² vs placebo
- Pain
- Improved in all groups
The research, explained
ARA-290, also called cibinetide, is an 11-amino-acid peptide based on part of EPO, the hormone that stimulates red blood cell production. That part is designed to protect tissue and calm inflammation without raising red blood cells.
Sarcoidosis is an inflammatory disease that can damage small nerve fibers, causing burning pain. Those fibers can be counted in the cornea, the clear front of the eye, with a technique called corneal confocal microscopy.
In this phase 2b trial, 64 people with sarcoidosis-related small nerve fiber loss and pain received cibinetide at one of three doses, or placebo, for 28 days. In the middle-dose group, corneal nerve fiber area rose by 697 µm² more than on placebo, a significant change. The lowest and highest doses did not reach significance. Regenerating nerve fibers in skin samples also increased in the middle-dose group.
Pain improved in all groups. People with moderate to severe pain on the middle dose reported a clinically meaningful drop compared with placebo, but that difference was not statistically significant.
Changes in corneal nerve fibers tracked changes in a 6-minute walk test. Researchers see corneal nerve counts as a possible early marker of whether a nerve treatment is working; it is not yet proof that people feel or function better.
ARA-290 research material, where listed, is in the research shop for laboratory use.
What does this mean?
Cibinetide may help damaged small nerves recover, based on a short trial with an early-marker outcome. Larger, longer trials are needed.
What don’t we know yet?
Why only the middle dose reached significance, whether the effect lasts, and whether it helps other kinds of nerve damage are unknown.
Watch and learn
Videos discussing the compounds in this article, plus background on the biology or the research methods. Each card explains its connection; recordings may predate the findings described here.
Pain Specialists Australia
BPC-157 for pain: what the evidence actually says
Two pain specialists weigh the evidence and the risks of BPC-157, TB-500, ARA-290, MOTS-c and GHK-Cu, including contamination of products sold online.
Dr Nick Christelis and Dr Bradley Lewinsohn, specialist pain medicine physicians (FFPMANZCA)
Discusses the compound
Two specialist pain physicians review the evidence for BPC-157 (from 16:08), TB-500 (24:04), ARA-290 (4:54), MOTS-c (25:51) and GHK-Cu (24:56), and the risks of unregulated products.
Khan Academy
Phagocytes and innate immunity
How part of the immune system responds to threats and contributes to inflammation.
Immune-system biology education
Related biology
Background on immune cells and inflammation for understanding ARA-290. It does not demonstrate benefits of this compound or formulation.
National Institute of Mental Health
What is clinical research?
Why studies in people are needed and what clinical research is designed to establish.
NIMH · US National Institutes of Health
Research skills
Helps you judge the study design or uncertainty in ARA-290 research; it is not a trial of the compound.
Sources and references
- Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic PainCulver et al. · Investigative Ophthalmology & Visual Science · 2017
- ARA 290 for treatment of small fiber neuropathy in sarcoidosisvan Velzen et al. · Expert Opinion on Investigational Drugs · 2014
VETUD Learn explains published research in plain language. It is general information, not medical advice. Talk to a doctor before starting, stopping or changing any treatment.
In the research shop
Check the catalog for related laboratory research materials. These products are separate from the approved medicines and clinical trial formulations discussed here.
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