Aldeyra Therapeutics announces anticipated submission of IND application for RASP modulator ADX-248 in patients with dry AMD

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Aldeyra Therapeutics announced the advancement of its RASP modulator platform, which includes the anticipated submission of an IND application of the investigational RASP modulator ADX-248 for a Phase ADX-629 1/2 clinical trial in patients with the dry form of age-related macular degeneration (AMD) and dark adaptation deficit.

Plans were described in more detail in a press release from Aldeyra.¹

“Metabolites of RASP are associated with compromise in dark adaptation. Based on data demonstrating that RASP modulation reduces accumulation of toxic metabolites in a preclinical model of AMD,” stated the company in the release.

The company also stated an IND application of next-generation investigational RASP modulator ADX-248 is expected to be submitted in 2024 and is anticipated to enroll dry AMD patients with dark adaptation deficit.

ADX-248 is an intravitreally administered RASP modulator in development for the treatment of immune-mediated diseases of the retina, including the dry form of age-related macular degeneration, geographic atrophy, and related diseases.¹

In addition to that, the announcement also included the “expected submission to the FDA of a proposed expansion of the Phase 2 clinical trial of the investigational RASP modulator ADX-629 in Sjögren-Larsson Syndrome to include pediatric patients, initiation of a Phase 2 clinical trial of ADX-629 in moderate alcoholic hepatitis, submission of an IND application of the investigational RASP modulator ADX-246 for a Phase 1 clinical trial that is expected to be expanded to include atopic dermatitis patients, and initiation of a preclinical program of RASP modulators in metabolic disease.”¹

“With an unparalleled RASP modulator discovery and development platform, Aldeyra remains a leader in the development of RASP modulators for the treatment of immune-mediated disease,” stated Todd C Brady, MD, PhD, president and CEO of Aldeyra.

Furthermore, the company also stated in the release that based on Special Protocol Assessment feedback received from the FDA on reproxalap in dry eye disease, Aldeyra has amended the proposed clinical trial protocol and statistical analysis plan.

References:

1. Aldeyra Therapeutics Provides Clinical and Regulatory Update and Announces Advancement of RASP Platform in Systemic and Retinal Inflammatory Diseases. Aldeyra Therapeutics; January 4, 2024. Accessed January 4, 2024. https://www.businesswire.com/news/home/20240104883191/en/Aldeyra-Therapeutics-Provides-Clinical-and-Regulatory-Update-and-Announces-Advancement-of-RASP-Platform-in-Systemic-and-Retinal-Inflammatory-Diseases