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Aldeyra Therapeutics announced positive top-line symptom, redness, and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease. The double-masked, single-center, parallel-group run-in cohort enrolled 23 patients: 12 patients were randomized to receive 0.25% reproxalap ophthalmic solution and 11 patients were randomized to receive vehicle ophthalmic solution. Patients received four doses one day prior to and two doses on the day of exposure to a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking. Over all time points in aggregate in the dry eye chamber, reproxalap was observed to be statistically superior to vehicle for the two assessed symptoms, visual analog scale, VAS, ocular dryness score and ocular discomfort score in the run-in cohort of TRANQUILITY. "The symptom improvement observed in the run-in cohort of TRANQUILITY announced today support the first-line potential use of reproxalap in dry eye disease, and represent the first results from an ophthalmic solution for chronic use that demonstrate activity acutely following drug administration," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "The activity of reproxalap in reducing ocular redness, initially demonstrated in the allergen chamber Phase 2 clinical trial, was also observed in the dry eye chamber run-in results of TRANQUILITY, and we look forward to initiating enrollment of the main cohort." Among many patients and physicians, current dry eye disease therapies are considered inadequate. Discontinuation rates for lifitegrast and cyclosporine, which currently comprise standard of care, exceed 60% within 12 months

Aldeyra Therapeutics announced confirmation of SARS-CoV-2 antiviral activity of ADX-1612, in addition to novel anti-inflammatory activity in SARS-CoV-2-infected primary human cells in preclinical studies. The results are derived from an international collaboration with the Max Delbruck Center for Molecular Medicine in the Helmholtz Association in Berlin, Germany, which plans additional studies with colleagues at the Charite - Universitatsmedizin Berlin University Hospital in cell and animal COVID-19 models. "The antiviral and anti-inflammatory activity of ADX-1612 demonstrated in COVID-19 models may be applicable to viral diseases generally," stated Emanuel Wyler, Ph.D., Research Scientist at MDC. "We look forward to continuing our collaboration with Aldeyra as we advance ADX-1612 to additional cell and animal models to further characterize the activity of ADX-1612 in COVID-19 and other viral infections," added Markus Landthaler, Ph.D., Group Leader of the Coronavirus Task Force and the Laboratory for RNA Biology and Post-transcriptional Regulation at MDC. In May 2020, Dr. Wyler and colleagues identified HSP90 as a key antiviral target against SARS-CoV-21 and have confirmed the antiviral activity of ADX-1612, a potent HSP90 inhibitor, reported by Aldeyra earlier this year. Additional reports of the activity of ADX-1612, also known as ganetespib, and other HSP90 inhibitors have been subsequently published by independent laboratories. The anti-inflammatory activity of ADX-1612, as assessed by cytokine transcription in SARS-CoV-2-infected primary human cells, included down-regulation of TNF-alpha, IFN-1beta, IL-6, and a variety of other cytokines and pro-inflammatory mediators.

Aldeyra announced the initiation of Phase 2 clinical trials of ADX-629, a first-in-class orally administered reactive aldehyde species, or RASP, inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis as part of a systematic strategy to assess activity across different types of immunological diseases. The Phase 2 clinical trials follow a Phase 1 clinical trial of ADX-629, which demonstrated no treatment-related adverse events at any dose tested, as well as target engagement evidenced by statistically lower RASP levels in drug-treated subjects relative to controls.