Briquilimab Phase 1b/2a Trial Begins for Chronic Inducible Urticaria

Jasper Therapeutics, a company dedicated to developing innovative treatments, has initiated a new clinical trial for a condition known as chronic inducible urticaria (CIndU). The treatment in question is briquilimab, a groundbreaking antibody therapy that targets the c-Kit receptor, which is implicated in mast cell-driven diseases. The Phase 1b/2a clinical study, dubbed SPOTLIGHT, marks a significant step in the exploration of briquilimab's potential to treat mast cell-mediated disorders.

The SPOTLIGHT study aims to assess the safety and efficacy of briquilimab when administered subcutaneously at two distinct dosages. It is anticipated that approximately 15 adult patients suffering from cold urticaria or symptomatic dermographism will participate in this trial, which is set to take place across four European Union sites. The primary focus of the study is on the safety and tolerability of the drug, with secondary goals that include evaluating its efficacy and understanding its pharmacokinetics.

Edwin Tucker, the Chief Medical Officer at Jasper, expressed enthusiasm for the study, drawing parallels to the BEACON study for chronic spontaneous urticaria (CSU). He anticipates that the SPOTLIGHT trial will not only confirm the mast cell-depleting effects of briquilimab but also aid in determining optimal dosing strategies for future studies. Preliminary findings are expected to be shared in the latter part of 2024.

Briquilimab is a monoclonal antibody that works by blocking the binding of stem cell factor to c-Kit, thereby inhibiting the signaling pathways that are essential for mast cell survival. This leads to the depletion of mast cells through apoptosis, which in turn mitigates the inflammatory response characteristic of chronic urticaria. The drug is also being studied for its potential in treating lower to intermediate risk myelodysplastic syndromes (MDS) and as a conditioning agent for stem cell transplants in rare diseases.

Jasper Therapeutics is a clinical-stage biotechnology firm that has shown promising results with briquilimab in over 145 participants and volunteers. The company's focus is on advancing treatments for chronic mast and stem cell diseases, leveraging the unique properties of briquilimab to address unmet medical needs.

The expertise of Professor Marcus Maurer, a renowned figure in dermatology and allergy, adds further credibility to the study. He believes that c-Kit inhibitors, like briquilimab, could revolutionize treatment for mast cell-driven diseases, offering new hope to patients with CIndU.

While the company is optimistic about the prospects of briquilimab, it is important to note that the journey from clinical trials to regulatory approval and market acceptance is fraught with challenges. The process is dependent on a multitude of factors, including clinical trial outcomes, regulatory decisions, market dynamics, and the ability to secure intellectual property protection. Despite these hurdles, Jasper Therapeutics remains committed to advancing briquilimab as a potential new treatment for patients in need.