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Avalo Announces it Has Completed Targeted Enrollment of 80 Patients in Phase 2 PEAK Trial of AVTX-002 in Non-Eosinophilic Asthma
Topline data expected in the second quarter of 2023 WAYNE, Pa. and ROCKVILLE, Md., Jan. 17, 2023 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX),
About this update from Avalo Therapeutics, Inc.
[{"type":"text","content":"Topline data expected in the second quarter of 2023 WAYNE, Pa. and ROCKVILLE, Md., Jan. 17, 2023 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced that it completed enrollment of the 80 patients targeted for the Phase 2 PEAK Trial evaluating AVTX-002 (anti-LIGHT mAb) in patients with Non-Eosinophilic Asthma (NEA). Avalo will allow additional patients currently in the run-in period to complete enrollment. Topline data from the clinical trial are expected to be released in the second quarter of 2023. “We are very excited to have completed target enrollment in our Phase 2 PEAK Trial in patients with NEA. We believe the data readout will yield yet another clinical proof of concept for LIGHT inhibition in patients suffering from lung inflammation. We expect these trial results will add to the accumulating clinical evidence that cytokines regulated by decoy receptor 3 (DcR3): LIGHT (and its signaling network including BTLA), TL1A and FasL are key drivers of inflammatory diseases in the lung, gut and skin. We are eager to advance AVTX-002 in treating NEA, asthma broadly, and other dysregulated inflammatory disease,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “I thank the patients who have enrolled in the trial, the clinical investigators and the Avalo team who worked tirelessly to advance the trial to this point.” The Phase 2 PEAK Trial is a randomized, double-blind, placebo-controlled, parallel group trial designed to evaluate the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA (NCT05288504). Following 12 weeks of treatment, the efficacy and safety of AVTX-002 will be evaluated compared with placebo. The primary endpoint is the proportion of patients who experience any of the following asthma-related events: (i) ≥6 additional reliever puffs of a short-acting beta-agonist (compared to baseline) in a 24-hour period on 2 consecutive days, or (ii) increase in inhaled corticosteroid dose ≥4 times than the dose at baseline, or (iii) a decrease in peak flow of 30% or more (compared to baseline) on 2 consecutive days of treatment, or (iv) an asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or (v) a hospitalization or emergency room visit because of an asthma exacerbation. About AVTX-002 A...