NexEos Bio Announces FDA Clearance of IND Application to Proceed to Phase II/III Trial of NTX-1024 in Vernal Keratoconjunctivitis
NexEos Bio Vision Health a clinical-stage biopharmaceutical company developing novel therapies and diagnostics targeting eosinophil-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared NexEos’s Investigational New Drug (IND) Application to proceed to a Phase II/III clinical trial of NTX-1024 for the treatment of patients with the rare disease, vernal keratoconjunctivitis (VKC). The planned Phase II/III trial is a single, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of NTX-1024 ophthalmic solution in patients with VKC.
This is on the heels of the positive results reported from an open-label, investigator-initiated study evaluating the efficacy, safety, and tolerability of NTX-1024 eye drops in adults with VKC. The study was conducted in Mexico and enrolled 15 patients with mild to moderate VKC who received NTX-1024 four times daily over a four-week period. Treatment led to significant improvement in patient-reported symptoms such as itching and quality of life, along with reductions in clinical signs of inflammation, including hyperemia and corneal fluorescein staining. NTX-1024 was also found to be safe and well-tolerated.
This marks the first clinical study to evaluate NTX-1024 in VKC, a rare and severe eosinophil-driven ocular condition that can lead to irreversible ocular damage, including vision loss, if left untreated. These results reinforce the therapeutic potential of NTX-1024 in VKC and have prompted NexEos to pursue further clinical development.
In addition, on January 16, 2026, the FDA granted Orphan Drug Designation to NTX-1024 for VKC.
Clearance of our IND application, which included data from our open-label investigator-initiated study in Mexico, is an important and meaningful step for the program,” said Steve Tullman, CEO and Chairman of NexEos. “We are excited to advance clinical development of NTX-1024, which would be the first, ophthalmic therapeutic to neutralizes eosinophil cationic protein to reduce inflammation in rare forms of Allergic Conjunctivitis – Vernal Keratoconjunctivitis (VKC) and Atopic Keratoconjunctivitis (AKC). We are on track to initiate our Phase II/III clinical trial by the second half of this year, taking us closer to our objective of delivering a best-in-class therapeutic option to patients with VKC.
About Vernal Keratoconjunctivitis (VKC)
VKC is a rare, chronic, and vision-threatening ocular inflammatory disease that is predominantly eosinophil-mediated. Activated eosinophils release toxic granule proteins, including eosinophil major basic protein-1 (eMBP1), resulting in damage to the ocular surface (Sacchetti, et al. 2021). VKC primarily affects children although approximately 10% of cases persist into adulthood (Di Zazzo A 2024).
About NTX-1024 (gleceparin sodium)
NTX-1024 is a novel, topical ophthalmic solution targeting eosinophil cationic protein mediated inflammation in rare forms of allergic conjunctivitis, including VKC and AKC. NTX-1024 has completed proof of concept in VKC, received ODD approval, and now has FDA clearance of its IND application to advance to a Phase II/III clinical trial in VKC. NTX-1024 is the first therapeutic successfully targeting neutralization of eosinophil cationic proteins. Finally, NTX-1024 has the potential to be the first drug to be disease-modifying and steroid-sparing in VKC and AKC.
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