Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) Rockets 13% Pre-Market with Positive Phase 2 Trial Results for ADX‑629 in Atopic Dermatitis

Date: December 19th, 2023 - In a remarkable pre-market surge today, December 19th, 2023, Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) has witnessed a significant increase in its stock price, soaring over 13%. The catalyst for this extraordinary uptick can be attributed to the company's announcement of highly encouraging results from a Phase 2 clinical trial of ADX-629, an investigational RASP modulator, in patients with atopic dermatitis.

Atopic dermatitis, a chronic inflammatory skin condition characterized by itching, redness, and rashes, affects millions of people globally. Patients suffering from this condition often seek effective, safe, and convenient treatment options. Aldeyra's announcement presents a glimmer of hope for those affected by atopic dermatitis.

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The Phase 2 clinical trial, an open-label, single-center study, involved eight patients with mild to moderate atopic dermatitis. Over a three-month period, participants received 250mg of ADX-629, administered orally twice daily. The primary focus of the trial was to assess safety and tolerability, with several secondary endpoints related to patient and investigator-reported outcomes.

The results are nothing short of impressive, with statistically significant and clinically relevant improvements observed across various physiological and psychosocial assessments. Key findings include:

Eczema Area and Severity Index (EASI): Statistically significant improvement from baseline was achieved, with an impressive p-value of 0.0006.

Investigator Global Assessment (IGA): Improvement was not only significant but achieved with an even lower p-value of less than 0.0001. The IGA threshold score of 0 (clear) or 1 (almost clear) was met in one patient (13%).

Patient-Oriented Eczema Measure (POEM): Clinically relevant thresholds of improvement, defined as a reduction of 4 or more points, were met in six patients (75%).

Hamilton Rating Scale for Depression (HAM-D): A statistically significant improvement (p=0.02) was observed in depression assessment.

Itching Relief: Two patients (25%) reported complete elimination of itching, a significant improvement in their quality of life.

Affected Body Surface Area: One patient (13%) experienced complete clearance of affected body surface area.

Crucially, all enrolled patients completed the trial without any protocol deviations. Only two mild adverse events, deemed possibly related to ADX-629, were reported, and there were no serious adverse events or discontinuations due to adverse events.

The results from this Phase 2 trial are consistent with the activity demonstrated in previous clinical trials of ADX-629, further solidifying the potential of RASP modulators in systemic diseases associated with inflammation.

Dr. Matthew Zirwas, Principal Investigator of the clinical trial, expressed optimism about the findings, stating, "The data announced today offer a glimpse into what may be possible for many patients who today are not adequately treated."

Aldeyra Therapeutics is now poised to advance ADX-246, an analog investigational drug of ADX-629, to a Phase 1/2 placebo-controlled clinical trial in healthy volunteers and patients with atopic dermatitis. This next-generation RASP modulator holds the promise of offering a safer and more convenient treatment option for atopic dermatitis patients.

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