Aldeyra Therapeutics Reshuffles Pipeline, Extends Cash Runway
Aldeyra Therapeutics, a biopharmaceutical company focused on developing novel therapies for immune-mediated diseases, has announced significant changes to its drug development pipeline. The company is discontinuing its RASP modulator ADX-629 while advancing two next-generation compounds, a move that extends its cash runway into the second half of 2027.
ADX-629 Discontinued Despite Promising Results
Despite reporting statistically significant liver function improvements in a Phase II alcohol-associated hepatitis study, Aldeyra has decided to halt the development of ADX-629. The drug, which was being investigated for various immune-mediated diseases including asthma, chronic cough, and atopic dermatitis, demonstrated a favorable safety profile with no serious adverse events detected. However, the company did not provide specific reasons for discontinuing the program.
Next-Generation RASP Modulators Take Center Stage
As part of its pipeline reorganization, Aldeyra is advancing two new RASP modulators:
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ADX-248: This compound will replace ADX-743 for metabolic inflammation indications, including obesity and hypertriglyceridemia. In a Phase I study, ADX-248 showed high levels of drug exposure with once-daily oral dosing.
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ADX-246: Set to replace ADX-631 for dry age-related macular degeneration, this molecule's advancement is supported by promising animal model data.
Aldeyra expects to file Investigational New Drug (IND) applications for both ADX-248 and ADX-246 in 2026.
Reproxalap's Regulatory Journey Continues
The pipeline shake-up comes in the wake of regulatory challenges for Aldeyra's lead RASP modulator, reproxalap, proposed for dry eye disease. After two FDA rejections citing insufficient efficacy evidence, Aldeyra has resubmitted its application with additional data from a clinical trial that achieved its primary endpoint of reducing ocular discomfort compared to a vehicle control. The FDA's decision on this third submission is anticipated on December 16, 2025.
References
- Aldeyra Cans RASP Asset, Brings Forward Two Others in Pipeline Shakeup
The reprioritization initiative extends Aldeyra’s cash runway into the second half of 2027.
Explore Further
What are the specific factors that led Aldeyra Therapeutics to discontinue the development of ADX-629 despite promising Phase II results?
How does ADX-248 compare in efficacy and safety to the discontinued ADX-743 for metabolic inflammation indications?
What are the competitive advantages of ADX-246 in treating dry age-related macular degeneration compared to other drugs in development or on the market?
What additional data or evidence has Aldeyra included in its resubmission to the FDA for reproxalap, and how does it address previous concerns about efficacy?
What impact will the extension of Aldeyra's cash runway into 2027 have on its long-term drug development strategy?