Aldeyra Announces Positive Top-Line Phase 1 Clinical Trial Results and Clinical Development Plans for ADX-629
The Phase 1 clinical trial was a single-ascending and multiple-ascending dose trial to assess the pharmacokinetic, pharmacodynamic, safety, and tolerability profile of ADX-629 administered orally to healthy volunteers. Of the 85 subjects enrolled in the trial, 41 received ADX-629 orally as a single dose; 23 received ADX-629 orally twice per day for 10 days; and 21 received placebo. ADX-629 was well-tolerated, and no treatment-related adverse events were observed in the trial. No clinically meaningful changes were observed in vital signs, quantitative electrocardiography, or blood chemistry results. Clinically relevant plasma concentrations exceeding known levels of RASP were observed. Relative to subjects treated with placebo, reduction in the commonly described pro-inflammatory RASP malondialdehyde was observed in treated subjects.
“To our knowledge, ADX-629 is the first orally available and irreversible covalent inhibitor of pro-inflammatory RASP, and potentially represents a new paradigm in the understanding and treatment of immune-mediated disease,” stated
Unlike most currently available drugs, the RASP targets of ADX-629 are small molecules rather than proteins. As such, ADX-629 could represent a new pharmacotherapeutic approach with potential applications across a large number of immune-mediated diseases. RASP are upstream mediators of inflammation, regulating known mediators such as NF-κB, inflammasomes, and scavenger receptor A. ADX-629 covalently binds RASP, which are then degraded intracellularly. In animal models of cytokine storm, ADX-629 and structural analog reproxalap, now in Phase 3 clinical testing for certain inflammatory ocular diseases, have demonstrated reduction in the levels of a variety of pro-inflammatory cytokines, including TNF-α, IFN-γ, IL-1, and IL-17, while upregulating the principal anti-inflammatory cytokine, IL-10.
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
In addition, contingent on clinical research facility availability, which is currently limited due to COVID-19 precautions, Aldeyra plans to test ADX-629 in Phase 2 clinical trials of respiratory and dermal conditions associated with elevated levels of RASP, potentially including atopic asthma, chronic cough, psoriasis, and atopic dermatitis.
“We are excited to add potential new milestones to our clinical pipeline as we advance ADX-629 to Phase 2 clinical testing and expand our clinical development focus to include systemic disease,”
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's strategy, future operations, prospects, plans, and objectives and Aldeyra's plans and expectations for its product candidates, including expectations regarding the potential of its RASP inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and antiviral activity in the treatment of COVID-19. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra’s ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra’s business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra’s limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra’s ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in
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