Aldeyra eyes Phase 3 after flunking Phase 2b

Dive Brief:

  • Mass.-based biotech Aldeyra Therapeutics has its eye on the prize — beginning a Phase 3 study of its allergic conjunctivitis drug ADX-102 even though its missed the primary endpoint in the Phase 2b study, ORA-CAC.
  • In patients with allergic conjunctivitis, ADX-102 did not meet its primary endpoint, which was absolute improvement of at least one point on a patient-reported scale of 0 to 4 five minutes after an allergen challenge. Patients with seasonal allergy reported reduction in itching of up to 0.8 points at five minutes, with extrapolation suggesting that the one-point threshold wasn't met until 20 minutes post-challenge.
  • Aldeyra expects to meet with the Food and Drug Administration in the second half of 2017, and then begin Phase 3 studies.

Dive Insight:

Aldeyra, a small biotech based in Lexington, Mass., is itching to get its drug into Phase 3, but it will remain to be seen what the FDA thinks of this plan.

"The consistent statistically significant reductions in ocular itching scores during the late phase of ocular allergy observed in Phase 2a and Phase 2b clinical trials have confirmed the clinical activity of our lead aldehyde trap, ADX-102, and strengthened our confidence in continued clinical development as a potentially differentiated product for the large worldwide market of allergic conjunctivitis patients whose symptoms are not relieved by standard of care antihistamines," commented Todd C. Brady, president and CEO of Aldeyra, keeping an upbeat tone despite the data miss.

The CEO's statement did eventually admit that the one-point improvement relative to vehicle at five minutes, equivalent to a 38% improvement in itch score was not met. However, he reiterated that "the threshold was approached in seasonal allergy patients, with peak changes of 0.8, and was exceeded on a percent change basis in this population 30 to 60 minutes after allergen challenge."

The news dropped the company's shares by 19% pre-market yesterday to eventually close at $4.65.

Aldeyra predicts a potential audience of patients with serious and chronic forms of allergic conjunctivitis that do not respond optimally to antihistamines, around a third of the total allergic conjunctivitis population.

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Filed Under: Clinical Trials
Top image credit: Flickr; Morgan