It’s been a rocky few years for Avalo Therapeutics, and the ride doesn’t look like it will be getting easier any time soon. The biotech's lead asset failed to stem asthma events, missing the main goal of a phase 2 clinical trial.
Avalo’s stock cratered 88% Monday, from $4.42 per share to 50 cents as of market close.
The biotech shared top-line results from a phase 2 randomized, placebo-controlled trial dubbed PEAK, which tested the monoclonal antibody AVTX-002 in patients with poorly controlled non-eosinophilic asthma for 14 weeks. The trial didn’t reach its primary goal, which was to reduce asthma-related events such as additional reliever puffs of a short-acting beta-agonist or increase in inhaled corticosteroid dose, among other measures.
AVTX-002 did demonstrate a favorable safety and tolerability profile in the study, according to Avalo.
Avalo, focused on treating immune dysregulation by developing therapies that target the LIGHT signaling network, said the asset did significantly reduce LIGHT levels. This was seen in a subpopulation of patients who had high LIGHT levels, which the company said suggests a potential biomarker for future study in severe non-eosinophilic asthma.
Certain evidence suggests that the dysregulation of the LIGHT network can drive autoimmune and inflammatory reactions, according to the biotech. Therefore, Avalo thinks diminishing LIGHT levels can moderate immune dysregulation in many disorders.
"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," said Avalo CEO and Chairman Garry Neil, M.D. "We continue to analyze these data with our scientific advisors to inform our next steps in asthma and potentially other indications."