Biopharmaceutical company DICE Therapeutics Inc. (DICE:NASDAQ), which utilizes its proprietary technology platform to create and develop novel oral therapeutic candidates for use in the treatment of chronic immune and other diseases, yesterday announced "positive topline data from its Phase 1 clinical trial of DC-806, an oral small molecule antagonist of the pro-inflammatory cytokine IL-17."
The company advised that DC-806 is its leading interleukin-17 (IL-17) antagonist that is being evaluated as a potential treatment for psoriasis. The firm noted that DC-806 has been well tolerated in the Phase 1 trial across all dose groups in healthy volunteers and psoriasis patients with a robust PK profile.
DICE Therapeutics indicated that both high and low doses of DC-806 administered to participants in the study provided clear beneficial pharmacodynamic results on two distinct biomarkers.
DICE shares opened 79% higher yesterday at $44.18 (+$14.265, +57.87%) over last Friday's $24.65 closing price and reached a new 52-week high price yesterday morning of $45.99.
The company explained that the randomized, double-blind Phase 1 trial was designed to evaluate the safety and pharmacokinetics of DC-806 in healthy volunteers and to serve as the basis for the potential use treatment of psoriasis patients.
The study included overlapping modules that included a Phase 1a single ascending dose, Phase 1b multiple ascending doses, and Phase 1c, which was structured under a proof-of-concept context for use in treating patients with psoriasis.
The firm emphasized that in the clinical proof-of-concept portion of the trial (Phase 1c), "psoriasis patients achieved with a mean percentage reduction in PASI from baseline at four weeks of 43.7% in the high dose group compared to 13.3% in the placebo group."
DICE Therapeutics advised that the data gathered in the trials provide staunch support for advancing DC-806 as a potential oral agent for treating psoriasis. The firm added that it intends to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) during H1/23 and stated that it plans to move forward with a dose-ranging Phase 2b clinical trial in patients with moderate-to-severe psoriasis in H1/23.
DICE Therapeutics' CEO Kevin Judice, Ph.D. stated, "We are extremely excited by the overall clinical profile of DC-806 and clear proof-of-concept in psoriasis in this Phase 1 clinical trial, which we believe is the first-ever clinical demonstration of direct inhibition of a cytokine with a small molecule."
Judice continued, "We believe these data not only support further development of DC-806 as a potential best-in-class oral therapy for psoriasis, but also may unlock additional IL-17-mediated disease indications given DC-806's excellent safety profile, strong PK data, and robust dose-dependent target engagement."
The company's Chief Medical Officer, Tim Lu, M.D., Ph.D., remarked, "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 provides 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."
DICE listed that "it is developing orally-available, small molecule antagonists of the pro-inflammatory signaling molecule IL-17, an immune cell-derived cytokine that is produced in response to infection by certain microorganisms."
The company stated in the report that there is no cure for psoriasis, which "manifests as erythematous plaques with thick scaling that can occur anywhere on the body." The disease causes symptoms that typically include itchiness, pain, and bleeding from scratching, which often results in scarring and disfiguration. The firm stated that according to the National Psoriasis Association, psoriasis affects about 125 million people globally.
DICE Therapeutics is a clinical-stage biopharma company based in South San Francisco, Calif., that focuses on developing and advancing new medicines for treating chronic autoimmune and inflammatory diseases.
The firm uses its proprietary DELSCAPE platform to build a pipeline of novel oral therapeutics to address well-validated targets in immunology that match or exceed the potency of their systemic biologic counterparts. The DELSCAPE platform can identify and discover selective oral small molecules that demonstrate potential for modulating protein-protein interactions (PPIs) that are equal to or better than systemic biologics.
DICE Therapeutics started off yesterday with a market cap of around $941.9 million, with approximately 38.21 million shares outstanding and a short interest of about 12.9%. DICE shares opened 79% higher yesterday at $44.18 (+$14.265, +57.87%) over last Friday's $24.65 closing price and reached a new 52-week high price yesterday morning of $45.99. The stock traded between $36.56 and $45.99 per share and closed for trading at $40.00 (+$15.35, +62.27%).
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