JW JoongWai Completes Phase 1 Clinical Trial of Atopy Drug Candidate... "Safety and Effective Dosage Confirmed"

[Asia Economy Reporter Choi Dae-yeol] JW Pharmaceutical has completed Phase 1 clinical trials for an atopic dermatitis drug candidate that it licensed out over two years ago. The company confirmed safety and effective dosage, and expects the trial results to serve as foundational data for future global clinical trials.

On the 16th, JW Pharmaceutical announced that it had completed Phase 1 clinical trials of the atopic dermatitis treatment 'JW1601' conducted in Korea with Korean, Caucasian, and Japanese participants, and had prepared the Clinical Study Report (CSR). JW1601 is a drug candidate that was licensed out in August 2018 at the preclinical stage to the global skin disease treatment company, Denmark's LEO Pharma, for a total of $420.2 million (approximately 480 billion KRW).

This compound selectively acts on the histamine H4 receptor, blocking the activation and migration of immune cells that cause atopic dermatitis and inhibiting the signal transmission of histamine that induces itching, exhibiting a dual mechanism of action. Unlike competing products focused mainly on anti-inflammatory effects, JW1601 simultaneously suppresses itching and inflammation and is being developed as an oral medication, making it convenient for patients to take, according to the company.

Since February last year, the company has been conducting Phase 1 clinical trials at Severance Hospital and Seoul National University Hospital involving 88 healthy Korean, Caucasian, and Japanese participants to evaluate safety, tolerability, drug efficacy, and biological responses. The dose-escalation cohort study, which determines the maximum tolerated dose, showed safety and excellent tolerability across all dosage groups. Additionally, biomarker analysis confirmed the effective dosage.

Based on preliminary data derived from single-dose clinical trials conducted in August last year, LEO Pharma submitted a clinical trial plan for dietary studies to the U.S. Food and Drug Administration (FDA). A JW Pharmaceutical official stated, "It is encouraging that we have confirmed safety and effective dosage in the development of histamine H4 receptor-targeting drugs, a field where no successful development has been achieved worldwide so far," adding, "We will strengthen our partnership with LEO Pharma to supply essential medication to patients with atopic dermatitis."