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In light of these preclinical results, standard and specialized neurologic and audiologic safety assessments and adjudication of events were conducted across the ALLEGRO program.25 Clinical data from the integrated safety analysis, including adjudicated events deemed possible neurologic or audiologic events of interest, showed no evidence of neurotoxicity with ritlecitinib treatment.25 Most AEs associated with neurologic events of interest such as dysesthesia, hyperesthesia, hypoesthesia, and paresthesia were mild in severity, considered by investigators to be unrelated to treatment, and resolved spontaneously.25 In a placebo-controlled phase 2a clinical safety study specifically evaluating potential neurologic/neuroaudiologic effects of ritlecitinib in adults with AA using BAEP assessments and intraepidermal axon histology, no notable effects were observed on nerve fiber counts, intraepidermal axon inflammation, or integrity of the human brainstem auditory pathway as assessed by BAEP.25 These data support that the dog finding of axonal dystrophy is not clinically relevant in humans.25 Laboratory assessments Ritlecitinib was associated with early, dose-dependent decreases in lymphocyte counts

This could play a role in possible mechanisms for immunomodulation explaining the inhibition of T cell proliferation upon stimulation with anti-CD2/CD3/CD28 when incubated with Al-CPI (65)

This highly purified, stable tripeptide structure has been clinically proven to survive the digestive tract far better than generic forms

Clin Exp Med