Avalo Therapeutics Fails to Meet Primary Endpoint in Phase 2 Clinical Trial


Avalo Therapeutics (Nasdaq: AVTX) has failed to meet its primary endpoint in a Phase 2 clinical trial evaluating AVTX-002 in patients with poorly controlled non-eosinophilic asthma (NEA). NEA is a subtype of asthma that does not respond well to standard treatments, including inhaled corticosteroids, and urgently needs new therapies.

Dr. Garry Neil, Chief Executive Officer and Chairman of the Board, said, “While the trial did not meet its primary endpoint, we are intrigued and encouraged by the finding that there was a trend toward fewer asthma related events in patients treated with AVTX-002 that had high serum baseline LIGHT levels.”


The Phase 2 PEAK trial was a randomized, double-blind, placebo-controlled, parallel group trial that enrolled a total of 91 patients.

The trial demonstrated a favorable safety and tolerability profile for AVTX-002, a fully human monoclonal antibody, but failed to meet its primary endpoint which was measured by the reduction in asthma-related events.

Positive trends were observed among a sub-population of patients with elevated baseline serum LIGHT levels. AVTX-002 significantly reduced serum LIGHT levels for study duration indicating target engagement.

Avalo thanked its team and the patients and clinical investigators for participating in the trial.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation by developing therapies that target the LIGHT-signaling network.

LIGHT and its signaling receptors, HVEM (TNFRSF14), and lymphotoxin β receptor (TNFRSF3), form an immune regulatory network with two co-receptors of herpesvirus entry mediator, checkpoint inhibitor B and T Lymphocyte Attenuator (BTLA), and CD160 (the LIGHT-signaling network). Accumulating evidence points to the dysregulation of the LIGHT network as a disease-driving mechanism in autoimmune and inflammatory reactions in barrier organs. Therefore, we believe reducing LIGHT levels can moderate immune dysregulation in many acute and chronic inflammatory disorders.

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Avalo Therapeutics Fails to Meet Primary Endpoint in Phase 2 Clinical Trial

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