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Celldex Announces First Patient Dosed in Phase 1 Study of CDX-0159 in Prurigo Nodularis
HAMPTON, N.J., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 1
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"HAMPTON, N.J., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 1 study of CDX-0159 for the treatment of prurigo nodularis (PN). CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. PN is a chronic skin disease that causes hard, intensely itchy lumps/nodules to form on the skin. The itching (pruritus) can be intense, causing people to scratch themselves to the point of bleeding or pain, which can form lesions and perpetuate the disease cycle. “The initiation of this study represents a significant milestone in the clinical development of CDX-0159 and its exciting potential to impact diseases with mast cell involvement,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “Research suggests mast cells play an important role in amplifying chronic itch and neuroinflammation in PN and we believe CDX-0159 has the potential to disrupt these pathways. PN is an often severe and debilitating disease with a significant impact on quality of life for patients and currently no approved treatment options. We look forward to advancing this program along with the rest of our clinical pipeline.” The randomized, double-blind, placebo-controlled, Phase 1 study is evaluating CDX-0159 in patients with prurigo nodularis. Approximately 40 patients will be enrolled across 4 parallel groups and treated for 8 weeks (1.5 mg/kg dose every 4 weeks, 3.0 mg/kg single dose followed by placebo 4 weeks later, 4.5 mg/kg single dose followed by placebo four weeks later and placebo dose every 4 weeks) with 10 patients in each group. Patients will be followed for 16-weeks after dosing. The primary endpoints of the study are safety and tolerability; secondary endpoints include clinical effect, pharmacokinetics and pharmacodynamics. For additional information on this trial (NCT04944862), please visit www.clinicaltrials.gov. About Prurigo NodularisPrurigo nodularis (PN) is a skin disease that causes hard, itchy lumps (nodules) to form on the skin. The itching (pruritus) can be intense, causing people to scratch themselves to the point of bleeding or pain, which can form lesions and perpetuate the disease cycle. Scratching can cause...