to advancing THB335 for the treatment of multiple mast cell-mediated inflammatory diseases
We’re advancing our lead product candidate, THB335, for the treatment of multiple mast cell-driven inflammatory diseases of the skin, airway and gastrointestinal tract. THB335 is a potent, highly selective, oral small molecule KIT inhibitor with a promising preclinical product profile.
An oral approach to KIT inhibition offers the potential for a meaningful advancement in the treatment paradigm for mast-cell mediated inflammatory diseases. In addition to improved patient convenience versus injectable therapies, daily oral therapy creates the opportunity for finer dose titration, and via its intracellular mechanism of action, eliminates the risk of antibody-mediated mast cell activation associated with biologic treatment approaches.
We are planning to focus our initial clinical development for THB335 in chronic urticaria. We also plan to pursue development of THB335 in additional diseases, where mast cells play a known role in their pathophysiology and symptomatology.
We plan to initiate a Phase 1 clinical trial during the first half of 2024 to evaluate the safety, pharmacokinetic and pharmacodynamic profile of THB335.
a severe, yet undertreated dermal inflammatory condition
Chronic urticaria is a dermatologic condition driven by mast cell activation that results in red, itchy, painful welts or hives that develop in response to a specific stimulus (inducible urticaria) or with no known cause (spontaneous or idiopathic urticaria). The condition carries a significant disease burden for patients, including decreased quality of life, impaired social and work function, depression, and sleep disruption.
Up to 1% of the US population is believed to be affected by urticaria at some point in their lives. Standard antihistamines, the first line of therapy, are only effective in about half of patients. An injectable biologic therapy is the only approved second-line treatment and provides complete symptom relief in a minority of patients.