Xequel Bio Announces Positive Results from Phase 1b Study of iNexin, a Novel aCT1 Ophthalmic Solution

Xequel Bio announced positive results from its phase 1b clinical trial with iNexin (aCT1 ophthalmic solution) for the treatment of corneal injury in patients with dry eye disease. The study demonstrated that iNexin was safe and well-tolerated at the doses tested, and early efficacy signals were observed.

This phase 1b trial was a single-center, randomized, double masked, vehicle-controlled clinical study to assess the safety and exploratory efficacy of iNexin for the treatment of corneal injury in patients with dry eye disease. There were no serious adverse events or dose-limiting toxicities associated with iNexin treatment. Improvements in both signs (e.g., corneal staining) and symptoms (e.g., ocular discomfort) of dry eye disease were observed within 2 weeks of treatment in both the environment and Ora’s controlled adverse environment (CAE) model, which exacerbates signs and symptoms of dry eye disease in a safe and standardized manner for greater precision in predicting treatment efficacy.

“These results support our belief that iNexin, our novel aCT1 ophthalmic solution, has the potential to improve patient outcomes by regulating the inflammatory response to promote improved ocular healing,” Jerry St. Peter, Chief Executive Officer, said in a company news release. “We are extremely pleased that the key goals of this study were met, providing clinical evidence of safety, tolerability, and also early signs of efficacy in patients with corneal injury. This data provides a strong basis to further refine our therapeutic focus and dosing regimen as we progress our ophthalmic development program, including designing our phase 2 clinical trial.”

Gail Torkildsen, MD, board certified ophthalmologist at Andover Eye Associates, said, “This study provides an initial look at the safety, tolerability, and potential biological activity of iNexin in treating dry eye disease, with a mechanism of action suggesting additional application in treating ocular injury and inflammation. The results are encouraging and indicate the potential for aCT1 to restore Connexin43, which plays a critical role in the inflammatory cascade. iNexin could represent an innovative solution to treat patients with corneal injuries by promoting healing and rebuilding healthy tissue through accelerated re-epithelialization.”

This phase 1b trial was a single-center, randomized, double masked, vehicle-controlled clinical study to assess the safety and exploratory efficacy of iNexin compared to vehicle in patients with dry eye disease. A total of 36 participants, with a subject-reported history of dry eye disease in both eyes, were enrolled and randomized in a 2:1 allocation for each of three concentrations of iNexin (0.08%; 0.4%; 2.0% aCT1) to vehicle (eye drop formulation without aCT1), administered bilaterally twice a day for 14 days. The primary objective of the trial was to evaluate the safety and tolerability of iNexin. The secondary objective was to compare the efficacy of iNexin to vehicle for the treatment of the signs and symptoms associated with dry eye disease.

This trial was managed and monitored by Ora and was supported by the Department of Defense Defense Health Program, Congressionally Directed Medical Research Program through Vision Research Program Award W81XWH-20-1-0879.