On May 5, 2022 eyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company developing innovative therapies for the treatment of immune-mediated diseases, reported recent corporate highlights and financial results for the quarter ended March 31, 2022 (Press release, Aldeyra Therapeutics, MAY 5, 2022, View Source [SID1234613676]).
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"Consistent with our planned completion this quarter of clinical development for reproxalap in dry eye disease and the recently announced demonstration of clinical activity of ADX-629 in three inflammatory diseases, we are delivering on our strategy to expand our RASP platform from the front of the eye to systemic disease, including clinical trials in ethanol toxicity, chronic cough, minimal change disease, and Sjögren-Larsson Syndrome," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Additionally, we continue to advance our intravitreal drug platform for the treatment of rare retinal diseases, highlighted by Phase 3 clinical trial results in proliferative vitreoretinopathy and Phase 2 clinical trial results in retinitis pigmentosa expected in the second half of this year."
Recent Corporate Highlights
Completed Enrollment in the Phase 3 TRANQUILITY-2 Trial in Dry Eye Disease. Aldeyra completed enrollment in the Phase 3 TRANQUILITY-2 Trial of 0.25% reproxalap ophthalmic solution in patients with dry eye disease. The primary endpoints of the TRANQUILITY-2 Trial are Schirmer test on the first day of dosing and ocular redness on the second day of dosing during exposure to a dry eye chamber. In a Phase 2 clinical trial and in the Phase 3 TRANQUILITY Trial announced last year, reproxalap demonstrated statistically significant superiority over vehicle in ocular redness and Schirmer test, respectively.
Reported Positive Top-Line Data and Announced New Indications for ADX-629. At its Research & Development Day in March, Aldeyra reported positive top-line data from Phase 2 proof-of-concept trials of ADX-629, a first-in-class orally administered RASP modulator, suggesting broad-based activity across a number of biomarker and clinical endpoints. Accordingly, Aldeyra announced the advancement of ADX-629 to Phase 2 clinical trials in four new indications: ethanol toxicity, chronic cough, minimal change disease, and Sjögren-Larsson Syndrome.
Initiated Phase 2 Clinical Trials of ADX-629 in Ethanol Toxicity and Chronic Cough. Patient enrollment has begun in the Phase 2 clinical trials of ADX-629 in ethanol toxicity and chronic cough. Up to 10% of adults in the U.S. abuse ethanol, which when done chronically can lead to the development of liver disease. Chronic cough, defined as a cough that lasts eight weeks or longer in adults, affects an estimated 13 million adults in the U.S., and up to approximately 10% of people worldwide.
Dry Eye Disease Clinical Data Presented at 2022 ASCRS Annual Meeting. Edward J. Holland, M.D., Professor of Ophthalmology at the University of Cincinnati, presented results from the run-in cohort of the Phase 3 TRANQUILITY Trial of reproxalap in dry eye disease at the 2022 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The TRANQUILITY run-in cohort demonstrated statistical superiority of reproxalap over vehicle in ocular redness during exposure to a dry eye chamber and in symptom scores after a single day of dosing.
Upcoming Planned Clinical and Regulatory Milestones
Dry Eye Disease: Results from the Phase 3 TRANQUILITY-2 Trial of reproxalap in dry eye disease are expected in the second quarter of 2022, followed by a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration, pending the outcome of TRANQUILITY-2 and enrollment in the 12-month safety trial of reproxalap in dry eye disease patients. Aldeyra is continuing to review data from the completed TRANQUILITY Trial to finalize analytical plans for the TRANQUILITY-2 results.
Allergic Conjunctivitis: Results from the Phase 3 INVIGORATE-2 allergen chamber trial of reproxalap in allergic conjunctivitis are expected in 2023. INVIGORATE-2 is a randomized, double-masked, crossover trial substantially similar in design to INVIGORATE, which demonstrated statistically significant superiority of reproxalap over vehicle for the primary endpoint of ocular itching and the key secondary endpoint of ocular redness.
Retinal Disease: Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in proliferative vitreoretinopathy, and from the Phase 2 clinical trial of ADX-2191 in retinitis pigmentosa, are expected in the second half of 2022.
Systemic Disease: Results from the Phase 2 clinical trial of ADX-629 in ethanol toxicity are expected in the second half of 2022, and results from the Phase 2 clinical trials of ADX-629 in chronic cough, minimal change disease, and Sjögren-Larsson Syndrome are expected in 2023.
First-Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities as of March 31, 2022 were $216.9 million. Based on its current operating plan, Aldeyra believes that existing cash, cash equivalents, and marketable securities will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submissions; initial commercialization of reproxalap, if approved; and continued development of Aldeyra’s product candidates in ocular and systemic immune-mediated diseases.
Net loss for the three months ended March 31, 2022 was $16.8 million, or $0.29 per share, compared with a net loss of $11.3 million, or $0.25 per share, for the comparable period of 2021. Losses have resulted from the costs of clinical trials and research and development programs, as well as from general and administrative expenses.
Research and development expenses for the three months ended March 31, 2022 were $12.2 million, compared with $7.7 million for the same period in 2021. The increase of $4.5 million is primarily related to increases in clinical research and development expenditures.
General and administrative expenses for the three months ended March 31, 2022 were $4.2 million, compared with $3.1 million for the same period in 2021. The increase of $1.1 million is primarily due to increases in consulting expenditures.
Total operating expenses for the three months ended March 31, 2022 were $16.5 million, compared with total operating expenses of $10.8 million for the same period in 2021.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to discuss recent corporate highlights and financial results for the quarter ended March 31, 2022. The dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The access code is 742862. Please dial in at least 10 minutes prior to the start time.
A live webcast of the conference call can be accessed via the Investors & Media page of Aldeyra’s website at View Source After the live webcast, the event will remain archived on the website for 90 days