Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVTX-002 · 1 trial · 1 indication
Percentage of patients who experience any of the following asthma related events: * ≥6 additional reliever puffs of Short-Acting Beta-Agonist (compared to baseline) in a 24-hour period on 2 consecutive days or, * increase in inhaled corticosteroid dose ≥4 times than the dose at baseline or, * a decrease in peak flow of 30% or more (compared to baseline) on 2 consecutive days of treatment, or * an asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or * a hospitalization or emergency room visit because of an asthma exacerbation
| Arm | Type | Description |
|---|---|---|
| AVTX-002 | EXPERIMENTAL | Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study. |
| Placebo | PLACEBO_COMPARATOR | Approximately 40 subjects will receive placebo sourced as normal saline three times during the study. |
| Name | Type | Description |
|---|---|---|
| AVTX-002 | DRUG | Dose of 600 mg administered subcutaneously three times during the study. |
| Placebo | DRUG | Placebo sourced as normal saline administered subcutaneously three times during the study. |
Inclusion Criteria: * Documented non-eosinophilic asthma diagnosis (\<300 eosinophils/μL). * Symptoms consistent with a diagnosis of asthma that is poorly controlled as determined by an ACQ score ≥ 1.5. * Poorly controlled asthma despite the use of a Long-Acting Beta-Agonists and Inhaled Corticoste...
AVTX-002 is an investigational small molecule developed by Avalo Therapeutics, Inc. (ticker AVTX) for the treatment of non-eosinophilic asthma, a form of asthma that does not respond to treatments targeting eosinophilic inflammation. It is in Phase 2 clinical development and has been studied in a single completed trial.
AVTX-002 is being developed to treat poorly controlled non-eosinophilic asthma in adults. Non-eosinophilic asthma is a subtype that does not show elevated eosinophil levels, so it tends to respond poorly to standard eosinophil-targeted biologics. AVTX-002 is intended for patients whose asthma remains inadequately controlled.
AVTX-002 targets LIGHT, a protein that belongs to the tumor necrosis factor superfamily and contributes to airway inflammation. By binding LIGHT, the small molecule is designed to interfere with inflammatory signaling implicated in non-eosinophilic asthma, a subtype not driven by eosinophils.
AVTX-002 is being developed by Avalo Therapeutics, Inc., which trades on the Nasdaq under the ticker AVTX. Avalo is the sponsor of the clinical program evaluating the drug in non-eosinophilic asthma.
AVTX-002 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 study in poorly controlled non-eosinophilic asthma has been completed, and no trials are currently listed as active.
AVTX-002 has been evaluated in one Phase 2 trial, NCT05288504, titled A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. The completed trial enrolled 91 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.