The parallel-group, randomised, double-blind, placebo-controlled study was designed to assess the efficacy and safety of AVTX-002 (anti-LIGHT mAb) in patients with poorly controlled NEA.
It recruited 91 patients who were administered subcutaneously with AVTX-002 600mg at days 0, 28 and 56 against a placebo.
The safety and efficacy of the therapeutic were compared against the placebo following 12 weeks of treatment.
The proportion of patients experiencing asthma-related events including ≥6 additional reliever puffs of a short-acting beta-agonist in a 24-hour period on two consecutive days was the trial’s primary endpoint.
A decrease in peak flow of 30% or more on two consecutive days of treatment and an increase in inhaled corticosteroid dose ≥4 times than the dose at baseline was also considered primary endpoints.
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Furthermore, an asthma exacerbation requiring the use of systemic corticosteroids for a minimum of three days, or a hospitalisation or emergency room visit were included as the study’s primary endpoints.
However, AVTX-002 was found to be safe and tolerable during the study.
Avalo Therapeutics CEO and board chairman Dr Garry Neil 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.
“Because LIGHT is the target of AVTX-002, this is consistent with the mechanism of action of the drug and our hypothesis going into the trial.
“We continue to analyse these data with our scientific advisors to inform our next steps in asthma and potentially other indications.”