TARRYTOWN, N.Y., July 21, 2020 /PRNewswire/ — Araim Pharmaceuticals Inc., today announced the publication of results from an exploratory clinical trial indicating efficacy of their lead compound, cibinetide, in treatment of diabetic macular edema (DME) (DOI: 10.3390/jcm9072225). The study was sponsored by the Belfast Health and Social Care Trust in Belfast, Northern Ireland, UK.
Cibinetide is a first-in-class synthetic peptide designed to activate innate repair mechanisms in the setting of tissue injury as a result of the inflammatory cascade. It selectively binds to the Innate Repair Receptor (IRR) which activates tissue protective, reparative, and anti-inflammatory signaling pathways. Preclinical studies at the Queens University Belfast and other institutions have shown that IRR activation decreases retinal leakage (edema) and improves glycemic control in diabetic models, and given its marked anti-inflammatory and anti-cell death properties, an open-label pilot clinical study was initiated by investigators at Queens University to evaluate the safety and efficacy of cibinetide for use in DME. Nine subjects with diabetic retinopathy and treatment-naïve severe DME (central retinal thickness of > 400 microns) self-administered 4 mg cibinetide subcutaneously daily for 12 weeks. While there was no significant effect on mean values of best-corrected visual acuity (BCVA), there was improvement in NEI-VFQ-25 composite scores, and some subjects exhibited improvements in BCVA, retinal sensitivity, central retinal thickness, tear production, and albuminuria, as well as improved metabolic control. Additionally, no serious adverse events/reactions were seen, and daily treatment for 84 days was considered safe and well tolerated. No patients developed antibodies against cibinetide.
«We are encouraged by the positive outcomes seen in this small proof-of-concept trial and look forward to further exploring the efficacy of cibinetide treatment in a larger cohort of DME patients,» commented Dr. Michael Brines, Chief Scientific Officer of Araim Pharmaceuticals. Dr. Noemi Lois, the lead investigator of the study, stated, «Vision loss due to macular edema is very common and hugely debilitating for people with diabetes. While anti-VEGF therapies are available, not all patients respond sufficiently to them, they require injection into the eye at short intervals and long-term treatment is needed, so there is a great need for new therapies to be developed and evaluated.»
About Diabetic Macular Edema
Diabetic macular edema is caused by fluid accumulation in the macula, the central portion of the retina responsible for the central vision. It affects more than 20 million people with diabetes worldwide and is a leading cause of vision loss. About a quarter of all people with the form of diabetic eye disease called diabetic retinopathy will develop DME. Inflammation is recognized to play a key role in the series of events that lead to the occurrence and persistence of diabetic retinopathy. Current treatment options for DME include macular laser, anti-VEGF (vascular endothelial growth factor) drugs injected into the eye and corticosteroid drugs either injected or implanted into the eye. These therapies improve DME outcomes but are invasive and not completely effective for many patients.
About Araim Pharmaceuticals, Inc.
Araim Pharmaceuticals, Inc. is a private clinical stage biopharmaceutical company with a library of peptides that activate the body’s own immune system to repair the damage of chronic disease and slow the aging process. We are focused on delivering novel therapies that slow, stop, and reverse chronic conditions. Through an extensive pre-clinical program in a wide array of disease conditions, Araim’s library of IRR agonists have demonstrated an ability to activate the endogenous system to reduce inflammation, stop the spread of injury, and activate healing and regeneration. Our most advanced program, cibinetide, has completed Phase 2 trials in Diabetic Neuropathy and Sarcoid Neuropathy, demonstrating reduction in pain and nerve regeneration.
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SOURCE Araim Pharmaceuticals, Inc.