Aldeyra Therapeutics Inc (NASDAQ:ALDX) Enters A Pact With FDA To Use RASP To Treat Dry Eye Disease: Completes IND Submission Of ADX-629 To Treat Patients With COVID-19

Aldeyra Therapeutics Inc (NASDAQ:ALDX) advances several clinical-stage programs that focus on developing ADX-629 and reproxalap. The company held discussions with the FDA in June 2020 and on track to begin a clinical study to assess RASP levels in patients suffering from dry eye disease.

Development of ADX-629

Aldeyra will commence ADX-629 drug development in H2 2020 to treat patients with atopic asthma, psoriasis, and COVID-19. Todd C. Brady, CEO of Aldeyra, said the company improved financial flexibility by offering its stock to Avidity Partners and Perceptive Advisors.

Aldeyra raised funds of $19.5 million through common stock sale at prevailing market prices. It will use the proceeds to support potential approvals of reproxalap to treat allergic conjunctivitis and dry eye disease through 2022.

Business activities

Aldeyra received an ODD (orphan drug designation) for its proprietary and innovative intravitreal formulation of methotrexate – ADX-2191 from the European Commission. The drug is used to treat retinal detachment.

Aldeyra is conducting Phase 3 clinical study of ADX-2191 to prevent recurrent retinal detachment because of PVR (proliferative vitreoretinopathy). As part of ODD for ADX-2191, the company is entitled to market exclusivity for 10 years in the EU, research funding, and protocol assistance.

Aldeyra submitted IND (Investigational New Drug) Application for ADX-629 to FDA under the accelerated coronavirus treatment program to commence Phase 2 clinical study in patients suffering from COVID-19. The company will initiate Phase 2 clinical study of ADX-629 in Q4 2020 to treat patients who have atopic asthma and psoriasis.

Aldeyra completed the recruitment of patients for Phase 2 clinical study of ADX-1612 to treat patients with Ovarian Cancer. NIAID (National Institute of Allergy and Infectious Diseases) will conduct additional preclinical testing of ADX-1612 to cure SARS-COV-2, which causes coronavirus. Aldeyra will reveal details of the effectiveness of ADX-1612 in treating SARS-COV-2 by the end of this year.

Aldeyra narrowed the loss to $7.5 million YoY in Q2 2020. Its losses are mainly on the backdrop of R & D costs ($4.9 million), clinical trials, and administrative and general expenses ($2.2 million). The company’s operating expenses also declined to $7.1 million YoY in Q2 2020.

Aldeyra’s and cash, CE (cash equivalents), marketable securities, are $66.2 million by the end of Q2 2020.