FDA clears iView Therapeutics IND application to start trial of TRPM8 agonist, IVW-1001

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iView Therapeutics announced the US Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical trial as “safe to proceed.”¹

The trial will evaluate the safety, efficacy, and tolerability of IVW-1001, a novel TRPM8 agonist, to treat signs and symptoms of dry eye diseases (DED). iView plans to move into Phase 1/2 clinical trials in the second quarter of 2024.

Houman Hemmati, MD, PhD, Chief Medical Advisor, and head of the clinical development of IVW-1001 said, “This investigational TRPM8 agonist represents an innovative approach in the treatment of dry eye diseases, a condition that challenges millions worldwide. FDA’s clearance of the IND is a critical milestone in our commitment to addressing the unmet needs of these patients through innovative science and targeted therapeutic development. We look forward to the possibility of advancing care in this important area.”¹

The transient receptor potential melastatin 8 (TRPM8) are cold-sensitive thermoreceptors that play a central role in tear film homeostasis. IVW-1001 is applied over the upper eyelid and stimulates TRPM8 located in the eyelid margin, sending a perception of coolness that reduces ocular discomfort and efferent signals for increased tear secretion may also be activated.²

IVW-1001 is part of the cryosims series of compounds created by Edward T. Wei, PhD, who also earlier identified and named the cooling molecule known as icilin. Cryosims have a sufficient duration of action and evoke the full spectrum of cooling from cool, cold, frigid cold, to noxious cold.

IVW-1001 has previously shown a short duration of action and improvement in key signs and symptom relief in an Investigator Sponsored Clinical Trial. It was able to increase tear production within 5-20 minutes of administration and longer lasting effects after 2 weeks of administration. This benefit was not accompanied by any adverse events.³

References:

1. iView Therapeutics Inc. Announced FDA’s Clearance of IND Application for IVW-1001 Ophthalmic Eyelid Wipe to Treat Signs and Symptoms of Dry Eye Disease. Press release; March 11, 2024. Accessed March 12, 2024. https://www.iviewtherapeutics.com/news/iView-Therapeutics-Inc.-Announced-FDA%E2%80%99s-Clearance-of-IND-Application-for-IVW-1001-Ophthalmic-Eyelid-Wipe-to-Treat-Signs-and-Symptoms-of-Dry-Eye-Disease

2. R&D. iView Therapeutics. Accessed March 12, 2024. https://www.iviewtherapeutics.com/researchAndDevelopment

3. Dry Eye. iView Therapeutics. Accessed March 12, 2024. https://www.iviewtherapeutics.com/researchAndDevelopment/IVW-1001