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$Aldeyra Therapeutics(ALDX)$ Potential of ADX-629 in COVID-19 lifts Aldeyra, up 14% premarket

Apr. 14, 2020 9:23 AM ET|About: Aldeyra Therapeutics, ... (ALDX)|By: Douglas W. House, SA News Editor
Thinly traded nano cap Aldeyra Therapeutics (NASDAQ:ALDX) is up 14% premarket on average volume on the heels of Phase 1 data on reactive aldehyde species (RASP) inhibitor ADX-629.

In 85 healthy volunteers, orally administered ADX-629 was well-tolerated with no treatment-related adverse events observed with clinically relevant plasma concentrations. Reductions in pro-inflammatory RASP malondialdehyde was noted in treated participants.

The company plans to meet with the FDA to clarify clinical testing of ADX-629 in COVID-19 patients with respiratory challenges. It has also filed the candidate under the FDA's Coronavirus Treatment Acceleration Program.

It plans to test ADX-629 in Phase 2 studies in patients with respiratory and dermal conditions associated with elevated RASP levels.

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肖恩大侠
2020-04-16 00:42

Aldeyra Announces Positive Top-Line Phase 1 Clinical Trial Results and Clinical Development Plans for ADX-629

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced positive top-line Phase 1 clinical trial results for ADX-629, a first-in-class orally available reactive aldehyde species (RASP) inhibitor in development for the treatment of systemic immune-mediated diseases. Aldeyra also announced Phase 2 clinical development plans for ADX-629.

Aldeyra plans to facilitate the clinical testing of ADX-629 in patients with COVID-19-associated respiratory compromise by requesting a pre-investigational new drug meeting with the Infectious Disease Division of the U.S. Food and Drug Administration (FDA). In addition, Aldeyra has filed ADX-629 under the FDA’s Coronavirus Treatment Acceleration Program (CTAP). By potentially mitigating aberrant cytokine responses, ADX-629 may delay or prevent progression of acute respiratory distress syndrome and other forms of respiratory compromise that generally require mechanical ventilation.