Treatment with cibinetide (ARA 290) was shown to promote significant corneal nerve and improve pain and functional capacity in a clinical trial with sarcoidosis patients. The trial was conducted by Araim Pharmaceuticals.
Results of the trial were published in the journal Investigative Ophthalmology & Visual Science, in an article titled “Cibinetide Improves Corneal Nerve Fiber Abundance In Patients With Sarcoidosis-Associated Small Nerve Fiber Loss And Neuropathic Pain.”
Sarcoidosis is a condition associated with chronic inflammation that can trigger loss of certain nerve fibers, leading to significant, disabling neuropathic symptoms, especially pain.
Cibinetide is a first-in-class synthetic 11-amino acid peptide that activates the Innate Repair Receptor (IRR), promoting tissue repair and recovery from inflammatory damage.
The Phase 2b trial (NCT02039687) included 64 sarcoidosis patients with painful neuropathy to investigate the safety and effectiveness of daily subcutaneous cibinetide treatment (at a dose of 1, 4, or 8 mg) compared to placebo for 28 days.
The study’s primary endpoint was to assess changes in small nerve fiber loss and repair.
Researchers found that treatment with cibinetide provided a significant increase (23 percent) in the corneal nerve fiber abundance in patients taking the 4 mg dose, compared to placebo.
As patients presented nerve fiber regeneration, they also experienced improved functional activity. Patients with moderate to severe pain at the start of the study reported a clinically meaningful decrease in pain intensity.
There were no safety issues reported during the study.
“There are no approved therapies to treat the underlying pathophysiology in neuropathy, and current symptomatic treatment options for patients suffering from the extremely debilitating and painful disease of sarcoidosis are often ineffective and/or injurious,” Daniel Culver, the trial’s principal researcher, said in a news release.
“The magnitude of effect in only 28 days is remarkable, and suggests that cibinetide has the potential to become a transformative disease modifying therapy for sarcoidosis patients as well as for other diseases characterized by chronic inflammation and persistent tissue injury,” Culver added.
Araim has met with the U.S. Food and Drug Administration (FDA) to advance the development of cibinetide.
“We are excited about the trial’s positive results which were the basis for a recently-completed successful end-of-phase 2 meeting with the FDA,” said Daiva Bajorunas, Araim’s chief medical office. “We look forward to taking the next step in clinical development for both neuropathic pain and disease modification indications.”