November 8, 2025

Sound Biologics Announces FDA Clearance of IND Application for QLP3119

BOTHELL, WA, UNITED STATES, November 7, 2025 /EINPresswire.com/ -- Sound Biologics today announced that the U.S. Food and Drug Administration (FDA) has completed its safety review of the company’s Investigational New Drug (IND) application for QLP3119 Injection (PSB219) and issued a “Study May Proceed” letter authorizing initiation of clinical testing in the United States.

The clinical trial will be a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple subcutaneous doses of QLP3119 Injection in healthy subjects. QLP3119 simultaneously targets TSLP and IL-33, two upstream epithelial cytokines that drive overlapping but distinct inflammatory pathways contributing to airway hyper-responsiveness in the lungs. By blocking both targets, QLP3119 can achieve broader and more durable suppression of airway inflammation than single-pathway blockade. Nonclinical studies demonstrated enhanced pharmacologic activity and a well-defined mechanism of action, supporting its advancement as a dual-specific biologic for respiratory inflammation.

“Our goal with QLP3119 is to create an effective treatment for patients with severe asthma and COPD that do not respond to current therapies.” Dr. Yan added. “We look forward to advancing this promising candidate through clinical development.”

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