THB-335 is an oral inhibitor of mast/stem cell growth factor receptor Kit (KIT), which regulates the activation and migration of mast cells, making it a relevant therapeutic target for inflammatory and allergic processes.
The closely watched chronic spontaneous urticaria (CSU, or hives) space chalked more early stage KIT inhibitor data as Third Harmonic Bio Inc. rolled out results from the phase I single and multiple ascending-dose trial with THB-335 in healthy volunteers, along with plans to move the oral candidate into phase II development by the middle of 2025.
When potentially dangerous high liver enzymes showed up in two asymptomatic participants during Third Harmonic Bio Inc.’s ongoing phase Ib study of the KIT inhibitor THB-001, the company decided to discontinue the clinical trial.
Third Harmonic Bio Inc. CEO Natalie Holles said the company’s $105 million in series B money will push THB-001 – a first-in-class, highly selective, oral inhibitor of wild-type KIT – “well past the first proof-of-concept study in inducible urticaria [hives].”