On May 4, 2023 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, reported recent corporate highlights and financial results for the quarter ended March 31, 2023 (Press release, Aldeyra Therapeutics, MAY 4, 2023, View Source [SID1234630997]).
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"Aldeyra continues to build a robust pipeline of novel drug candidates for the treatment of immune-mediated diseases," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Multiple regulatory and clinical catalysts are planned for the coming quarters, including PDUFA dates for ADX-2191 and reproxalap, top-line results from our Phase 2 clinical trials in retinitis pigmentosa and chronic cough, and top-line results from our Phase 3 INVIGORATE-2 trial in allergic conjunctivitis."
Recent Corporate Highlights
Enrollment Completed in the Phase 2 Clinical Trial of ADX‑2191 in Retinitis Pigmentosa: The open-label, single-center Phase 2 clinical trial enrolled a total of eight retinitis pigmentosa patients with rhodopsin gene mutations, including the P23H gene mutation. Patients receive either monthly or twice-monthly intravitreal doses of ADX‑2191 for three months. The primary endpoint of the trial is safety. Secondary endpoints include change from baseline in visual acuity; retinal function, as assessed by foveal microperimetry, electroretinography, and dark adaptation; and retinal morphology, as assessed by optical coherence tomography. ADX-2191, an investigational drug candidate, is a novel intravitreal formulation of methotrexate, which in preclinical models of retinitis pigmentosa facilitates the clearance of misfolded rhodopsin, a critical visual cycle protein susceptible to genetic mutation.1 Top-line results from the Phase 2 clinical trial are expected in the second quarter of 2023.
Enrollment Completed in the Phase 2 Clinical Trial of ADX-629 in Chronic Cough: The multicenter, randomized, double-blind, placebo-controlled, two-period Phase 2 crossover trial enrolled 51 patients with refractory or unexplained chronic cough, which is often defined as a cough that persists for more than eight weeks. Patients were randomized to receive ADX-629 or placebo twice daily for two weeks, followed by a two-week washout period prior to crossing over to two weeks of treatment with ADX-629 or placebo, whichever was not received in the first period. The primary endpoint of the trial is safety. Secondary endpoints include awake cough frequency, 24-hour cough frequency, patient-reported cough severity, quality of life, and patient and clinician global impression of change. ADX-629, an investigational new drug candidate, is a novel, orally administered RASP (reactive aldehyde species) modulator for the potential treatment of systemic immune-mediated diseases. RASP were observed in a preliminary observational study to be elevated in the bronchioalveolar lavage fluid of patients with chronic cough,2 and may contribute to neurosensory dysfunction as well as inflammation. Top-line results from the Phase 2 clinical trial are expected in the second quarter of 2023.
First Patient Enrolled in the Phase 2 Clinical Trial of ADX-629 in Atopic Dermatitis: The multicenter, adaptive, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 alone and in combination with standard of care in adults with mild, moderate, or severe atopic dermatitis. In Part 1, approximately 10 patients will receive open-label ADX‑629 twice daily for three months. Outcomes will include improvement in Investigator Global Assessment and Eczema Area and Severity Index scores. In patients with atopic dermatitis, the pro-inflammatory RASP malondialdehyde is elevated compared to levels observed in healthy controls.3 Top-line results from Part 1 are expected in the second half of 2023. Pending the results of Part 1, Part 2 will randomize patients to receive either ADX‑629 or placebo treatment twice daily for three months.
Enrollment Completed in the Phase 3 INVIGORATE-2 Clinical Trial of Reproxalap in Allergic Conjunctivitis: The randomized, double-masked, crossover, vehicle-controlled Phase 3 clinical trial enrolled 131 seasonal allergic conjunctivitis patients who were evaluated for 3.5 hours in an allergen chamber designed to simulate real-world pollen exposure. Consistent with pivotal trials of approved allergic conjunctivitis products, the primary endpoint of INVIGORATE-2 is patient-reported ocular itching. The protocol of INVIGORATE-2 is substantially identical to that of the Phase 3 INVIGORATE clinical trial and a Phase 2 clinical trial,4 both of which achieved the ocular itching endpoint (P<0.001). Reproxalap, an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory disease. Top-line results from the Phase 3 INVIGORATE-2 clinical trial are expected in second quarter of 2023.
Additional Planned Clinical and Regulatory Milestones
Results from Phase 2 Clinical Trials of ADX-629: Top-line results from Phase 2 clinical trials of ADX‑629 in idiopathic nephrotic syndrome (Part 1) and Sjögren-Larsson Syndrome are expected in the second half of 2023. Idiopathic nephrotic syndrome is a rare inflammatory kidney disease characterized by inflammation. Sjögren-Larsson Syndrome is an inborn error of metabolism characterized by mutations in an enzyme that metabolizes RASP.
Type C Meeting with the FDA for ADX-2191 in Proliferative Vitreoretinopathy: Aldeyra plans to conduct a Type C meeting with the U.S. Food and Drug Administration in the second half of 2023 to discuss the completion of clinical development of ADX‑2191 for the prevention of proliferative vitreoretinopathy, a rare sight-threatening disease that occurs following retinal detachment.
Initiation of Clinical Trials of Next-Generation RASP-Modulator Drug Candidates for Systemic Immune-Mediated Diseases and Geographic Atrophy: Pending completion of Investigational New Drug requirements, a Phase 1 clinical trial of orally administered ADX‑246 for the treatment of systemic immune-mediated diseases, and a Phase 1/2 clinical trial of intravitreally injected ADX‑248 for the treatment of geographic atrophy, a sight-threatening retinal disease, are expected to initiate in the second half of 2023 or early 2024.
First-Quarter 2023 Financial Results
Cash and cash equivalents as of March 31, 2023 were $165.0 million. Based on its current operating plan, Aldeyra believes that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses into the second half of 2024, including the initial commercialization and launch plans for reproxalap and ADX-2191, if approved, and continued early and late-stage development of Aldeyra’s product candidates in ocular and systemic immune-mediated diseases.
Net loss for the three months ended March 31, 2023 was $15.6 million, or $0.27 per share, compared with a net loss of $16.8 million, or $0.29 per share, for the comparable period of 2022.
Research and development expenses for the three months ended March 31, 2023 were $11.2 million, compared with $12.2 million for the same period in 2022. The decrease of $1.0 million was primarily related to a decrease in external clinical development costs, offset by an increase in personnel costs, drug product manufacturing expenditures, external preclinical development costs, and consulting expenditures.
General and administrative expenses for the three months ended March 31, 2023 were $5.6 million, compared with $4.2 million for the same period in 2022. The increase of $1.4 million was primarily related to higher personnel costs and legal expenditures, offset by a decrease in consulting expenditures.
Total operating expenses for the three months ended March 31, 2023 were $16.8 million, compared with total operating expenses of $16.5 million for the same period in 2022.
Beginning with this announcement of first quarter 2023 financial results, Aldeyra will no longer conduct quarterly conference calls to discuss financial results. Aldeyra plans to continue hosting conference calls, as appropriate, to report the results of certain clinical trials and other material information concerning regulatory and clinical developments.