Aldeyra halts trials, focuses on ocular assets to stretch runway

Eye
Aldeyra hired a senior vice president of clinical development that worked on Novartis' Xiidra. (Pixabay)

Aldeyra Therapeutics has halted clinical development of two systemic disease programs to stretch out its cash runway to the end of next year. The action is intended to enable Aldeyra keep pushing its ocular disease programs through late-phase development despite its falling cash reserves.

Massachusetts-based Aldeyra ended last year with $73.4 million in ready assets, having drawn $15 million from its debt facility in September. Aldeyra’s ability to raise more money from public investors has been diminished by its falling stock price, which has spiraled down more than 60% over the past year. At the same time, Aldeyra has continued to spend on late-phase ocular disease programs.

Now, Aldeyra has decided to make those ocular disease programs the priority for its remaining cash reserves. The main drug candidates to lose out as a result of the decision are a dermal formulation of reproxalap and ADX-1612.

Aldeyra began a phase 3 trial of the dermal formulation of small molecule RASP inhibitor reproxalap in patients with Sjogren-Larsson syndrome in 2018. According the ClinicalTrials.gov, the study is due to wrap up in December. Yet, facing a cash crunch, Aldeyra has decided to put clinical development of the dermal formulation on hold.

The action also affects ADX-1612, an inhibitor of heat shock protein 90 that Aldeyra planned to move into phase 2 in post-transplant lymphoproliferative syndrome in the fourth quarter. Aldeyra disclosed that ambition in November, but has now rowed back from the plan.

Putting the two programs on pause leaves Aldeyra fully focused on its ocular disease pipeline, which features two late-phase assets. Aldeyra expects to complete a phase 3 trial of an ocular formulation of reproxalap in allergic conjunctivitis the second half of the year. Another phase 3 trial in the ocular indication met its primary endpoint last year, although details in the data sank Aldeyra’s stock.

Freed from the need to invest in the systemic candidates, Aldeyra expects to have the cash to finish the second phase 3 trial in allergic conjunctivitis while putting reproxalap and another asset through other late-phase tests. Part two of a late-phase trial of reproxalap in dry eye disease is due to start in the second half of the year.

Aldeyra is also testing another ocular disease asset, an intravitreal formulation of methotrexate, in a phase 3 proliferative vitreoretinopathy trial. The trial is scheduled to compere enrollment next year.

With Aldeyra’s shift in focus tying its future to the ocular disease assets, the biotech has hired a senior vice president of clinical development with expertise in the therapeutic area to take the programs forward. James Gow joins Aldeyra on the back of his work as global development lead for Novartis’ dry eye disease drug Xiidra.

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