DICE Therapeutics, Inc. (DICE), a biopharmaceutical company, announced Tuesday positive topline data from its Phase 1 clinical trial of DC-806 for Psoriasis.
The company said it plans to advance DC-806 into a dose-ranging Phase 2b clinical trial in patients with moderate-to-severe psoriasis. An investigational new drug or IND application will be submitted with the U.S. Food and Drug Administration in the first half of 2023 and initiate Phase 2b development.
In pre-market activity on Nasdaq, DICE shares were gaining around 68.5 percent to trade at $41.54.
DC-806 is an oral small molecule antagonist of the pro-inflammatory cytokine IL-17.
The trial was a first-in-human, randomized, double-blind, placebo-controlled study designed to generate safety and pharmacokinetic or PK data in healthy volunteers as well as provide early clinical proof-of-concept in psoriasis patients.
The trial was conducted in three overlapping parts: Phase 1a single ascending dose or SAD; Phase 1b multiple ascending dose or MAD; and Phase 1c proof-of-concept in psoriasis patients.
The company noted that the clinical proof-of-concept in psoriasis patients achieved with a mean percentage reduction in PASI from baseline at 4 weeks of 43.7% in the high dose group compared to 13.3% in the placebo group.
In the study, DC-806 was well tolerated with an excellent safety profile across all dose groups in healthy volunteers and psoriasis patients with a robust PK profile and clear pharmacodynamic effects.
Tim Lu, chief medical officer of DICE Therapeutics, said, “Based on the Phase 1 clinical trial, we believe DC-806 has the potential to be the best-in-class oral therapeutic agent for patients with psoriasis…. Data from this Phase 1 clinical trial provide early evidence for the potential differentiation of DC-806 on efficacy, safety, and ease of use. We look forward to advancing DC-806 into a Phase 2b clinical trial to optimize dosing and further explore peak efficacy with a longer duration of treatment.”
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