- Part 1 of Adaptive Phase 3 RENEW Trial in Dry Eye Disease Expected to be Completed in Fourth Quarter 2019
- Meeting with FDA Scheduled in Fourth Quarter 2019 to Confirm Design of Second Phase 3 Trial in Allergic Conjunctivitis
- Initiation of the Adaptive Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy Planned for Fourth Quarter 2019
- Part 1 of Adaptive Phase 3 RESET Trial in Sjögren-Larsson Syndrome Completed
LEXINGTON, Mass.–(BUSINESS WIRE)–$ALDX–Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced quarter ended June 30, 2019 financial results and provided a corporate update.
“With Part 1 of our first Phase 3 trial in dry eye disease expected to be completed later this year, Aldeyra continues to advance reproxalap, the lead product candidate in our novel RASP inhibitor platform, towards commercialization,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “In addition, in the fourth quarter of 2019, we expect to confirm the design of our second Phase 3 trial of reproxalap in allergic conjunctivitis and initiate Phase 3 clinical testing of ADX-2191 in our first retinal indication, proliferative vitreoretinopathy, a rare and potentially blinding inflammatory disorder with no approved therapies.”
Recent Highlights and Corporate Updates
- Dry Eye Disease – Part 1 of the Adaptive Phase 3 RENEW Trial Expected to be Completed in Fourth Quarter of 2019. Aldeyra announced completion of enrollment in Part 1 of the two-part adaptive Phase 3 RENEW Trial of topical ocular reproxalap in dry eye disease. Following completion of Part 1 of RENEW, expected in the fourth quarter of 2019, Aldeyra plans to report the endpoints, dosing regimen, and sample size for Part 2 of the trial. Top-line results of the RENEW Trial are expected to be announced following completion of Part 2.
- Allergic Conjunctivitis – FDA Meeting Scheduled for Fourth Quarter to Confirm Design of Second Phase 3 Clinical Trial. In March 2019, Aldeyra reported positive top-line results from the Phase 3 ALLEVIATE Trial of topical ocular reproxalap in allergic conjunctivitis, and plans to present full results of ALLEVIATE at the American Academy of Ophthalmology 2019 Annual Meeting in October 2019. In addition, in June of 2019, Aldeyra announced results of topical ocular reproxalap in an allergen chamber trial, which demonstrated that ocular itching and redness in reproxalap-treated patients were statistically lower than that of vehicle-treated patients. A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled in the fourth quarter of 2019 to confirm the design of a second Phase 3 trial.
- Proliferative Vitreoretinopathy – the Adaptive Phase 3 GUARD Clinical Trial of ADX-2191 Expected to Initiate in the Fourth Quarter of 2019. Later this year, Aldeyra expects to initiate the adaptive Phase 3 GUARD Trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). The trial will compare recurrence rates across patients treated with ADX-2191 or standard of care following surgical repair of retinal detachment due to PVR. PVR is expected to be the first indication in Aldeyra’s retinal disease platform to begin clinical testing.
- Sjögren-Larsson Syndrome – Part 1 of the Phase 3 RESET Trial Completed. In Part 1 of the two-part adaptive Phase 3 RESET trial in Sjögren-Larsson Syndrome, investigator-assessed dermal scaling scores in the six patients treated with 1% reproxalap topical dermatologic formulation were statistically lower than pre-treatment values over six months of therapy, an improvement that was numerically greater than that observed in the three patients treated with vehicle, when adjusted for baseline score. Prior to initiating subsequent clinical testing, Aldeyra plans to discuss the RESET Part 1 results with regulatory authorities. The RESET Trial is a randomized, multi-center, double-masked Phase 3 clinical trial of 1% topical dermal reproxalap for the treatment of ichthyosis, a severe skin disease associated with Sjögren-Larsson Syndrome.
- Programs in Systemic Immune-Mediated Diseases Expected to Begin Clinical Testing in 2019. As Aldeyra expands to the development of therapies for the treatment of systemic immune-mediated disease, a Phase 2 clinical trial of ADX-1612 in post-transplant lymphoproliferative disorder and a Phase 1 clinical trial of ADX-629 for the treatment of systemic autoimmune and metabolic disease remain on track to be initiated in the second half of 2019.
Quarter Ended June 30, 2019 Financial Review
For the quarter ended June 30, 2019, Aldeyra reported a net loss of approximately $13.3 million, compared to a net loss of approximately $9.1 million for the quarter ended June 30, 2018. Basic and diluted net loss per share was $0.49 for the quarter ended June 30, 2019, compared to $0.46 per share for the same period in 2018. Losses have resulted from the costs of research and development programs, as well as from general and administrative expenses.
Research and development expenses were $10.7 million for the quarter ended June 30, 2019, compared to $6.8 million for the same period in 2018. The increase of $3.9 million is primarily related to an increase in manufacturing, preclinical, and clinical development costs; an increase in personnel costs; and non-cash compensation costs related to a portion of upfront acquisition consideration that is subject to vesting based on continued service.
General and administrative expenses were $3.1 million for the quarter ended June 30, 2019, compared to $2.4 million for the quarter ended June 30, 2018. The increase of $0.7 million is primarily related to an increase in personnel costs.
For the quarter ended June 30, 2019, total operating expenses were approximately $13.7 million, compared to total operating expenses of approximately $9.2 million for the same period in 2018.
Cash, cash equivalents, and marketable securities were $69.5 million as of June 30, 2019.