South Korea’s JW Pharm said on Wednesday the Ministry of Food and Drug Safety has approved a phase I clinical study of its investigational atopic dermatitis drug JW1601.
JW Pharm signed an out-licensing deal to Danish pharmaceutical company Leo Pharma, a leader within the field of dermatology in August for $402 million when the molecule was in a pre-clinical trial.
Its shares ended Wednesday at 35,250 won ($31.39), down 1.4 percent.
The candidate drug selectively binds to histamine H4 receptors and blocks the activation and movement of immune cells that cause atopic dermatitis and inhibits the signaling of histamine that causes itching. Unlike rival products focused on anti-inflammation, the new drug clamps down on both itching and inflammation.
It is also an orally-administered drug, which is more convenient than ointment or injectable agents.
JW Pharm said 88 healthy Koreans and Caucasians will participate in the phase I study at Severance Hospital to evaluate the drug’s safety, tolerability, efficacy and vital reactions. The proposed study will last until 2019. Leo Pharma is due to begin a global phase II study from 2020.
The global atopic dermatitis market was valued at $4.57 billion in 2016 and is expected to grow to $7.3 billion in 2024.
By Kim Hye-soon and Minu Kim
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