JW Pharmaceutical's JW1601 begins Phase 2 clinical trials
JW1601, an oral atopy treatment candidate that was licensed by JW Pharmaceutical to Ballerup, Denmark-based Leo Pharma began Phase 2 clinical trials, the Korean company said Wednesday.
The clinical trials will take place globally in Europe, Northern America, Japan, and Australia. They will be conducted on atopic patients with moderate and severe symptoms to test the candidate's safety and efficacy.
JW Pharmaceutical in 2018 signed a deal potentially worth $402 million with Leo Pharma for the transfer of related technology, which was in preclinical trials at the time. JW receives double-digit royalties based on the future sales of the treatment.
Leo Pharma holds exclusive rights to market the treatment in foreign countries, while JW Pharmaceutical maintains the rights to market in Korea.
The clinical trials participants will be classified into two groups, one given with the candidate and other the placebo. The company will observe the patients for 16 weeks to see whether any improvement is seen in those applying JW1601.
Atopic dermatitis is a skin inflammatory disease of unknown cause and is a chronic disease for which there is no clear cure, according to JW. The number of patients with atopic dermatitis is around 50 million globally.
"There is confidence in the fact that Leo Pharma, a global leader in medical dermatology market, is leading the global clinical trials of JW1601," Lee Seong-yeol, CEO of JW Pharmaceutical, said in Wednesday's statement. "We will strengthen cooperation with Leo Pharma to ensure the development process stays on the path to success."
BY SARAH CHEA [firstname.lastname@example.org]