Celldex Therapeutics Inc. (NASDAQ:CLDX) has announced results from its first phase, double-blind, randomized, placebo-controlled, dose-escalation KIT inhibitor CDX-0159 study in healthy subjects.
CDX-0159 shows a profound reduction in plasma tryptase
The company presented the data at the 2020 Annual Congress of the European Academy of Allergy and Clinical Immunology. According to the results, CDX-0159 has shown encouraging safety profiles and profound and durable plasma tryptase reductions that are consistent with complete suppression of mast cell. The results showed that a single CDX-0150 dose brought dose-reliant tryptase reduction to the level bellow assay detection after days of administering low doses of around 1mg/kg. Equally, there was prolonged suppression for more than two months for doses of 3mg/kg and above.
Mast cells exclusively secrete and synthesize enzyme tryptase, and a decline in tryptase levels in plasma is a reflection of the systemic drop in mast cell burden. This was observed in both disease and healthy volunteers, which thus offered a significant proof of concept for the study. Similarly, the data supports the expansion of study into mast cell-driven ailments that include chronic urticaria (CU) studies considering the prominent role that mast cells play in CU etiology.
Celldex to advance CDX0159 into clinical trials
Celldex SVP and Chief Medical Officer Diane Young indicated that the results support CDX-0159’s expedited advancement in the target patient groups’ clinical trials. Diane indicated that the company was looking forward to commencing studies later in 2020 in chronic inducible and spontaneous urticaria both of which are diseases driven by mast cells. Most importantly the indications will offer data readouts in the process with the company expected to provide chronic inducible urticaria data early in2021 and that of chronic spontaneous urticaria in the second half of next year.
Dr. Marcus Maurer, a leading urticaria expert and Dermatology and Allergy Professor presented the program’s data. He indicated a favorable safety profile and a significant reduction in plasma tryptase, indicating that CDX—0159 could potentially be a disease-modifying therapy for mast cell-driven diseases.