LY4100504 / Eli Lilly - LARVOL DELTA

The Remaining Unmet Needs in Plaque Psoraisis: Oral Therapies (AAD 2025) - " Among currently available advanced systemic options, there is a 20-25% difference in the proportion of patients receiving deucravacitinib and apremilast who are considered well-managed compared to biologics...Thus, 77% and 75% select DC-806 and JNJ-2113 as the preferred assets to gain FDA approval. Dermatologists are seeking safe and effective oral therapies and believe that oral IL-17 and IL-23 agents are better suited to meet this need compared to other oral treatments."

Dermatology • Immunology • Psoriasis • IL17A • IL23A

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study to Assess S011806 (DC-806 or LY4100504) in Healthy Adult Participants and Participants With Chronic Plaque Psoriasis (clinicaltrials.gov) - P1 | N=104 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial • Dermatology • Immunology • Psoriasis

Illuminate: A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=229 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion

Illuminate: A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=229 | Active, not recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2024 ➔ Mar 2024 | Trial primary completion date: Jul 2024 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial

Mass Balance and Pharmacokinetics (PK) of [14C]-DC-806 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: DICE Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: DICE Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion

Mass Balance and Pharmacokinetics (PK) of [14C]-DC-806 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: DICE Therapeutics, Inc.

New P1 trial

A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: DICE Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: DICE Therapeutics, Inc.

New P1 trial

Lilly to Acquire DICE Therapeutics to Advance Innovation in Immunology (PRNewswire) - "Eli Lilly and Company...and DICE Therapeutics, Inc...today announced a definitive agreement for Lilly to acquire DICE....Lilly will commence a tender offer to acquire all outstanding shares of DICE for a purchase price of $48 per share in cash (an aggregate of approximately $2.4 billion) payable at closing. The transaction has been approved by the boards of directors of both companies. The transaction is not subject to any financing condition and is expected to close in the third quarter of 2023, subject to customary closing conditions, including receipt of required antitrust clearance and the tender of a majority of the outstanding shares of DICE's common stock."

M&A • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis

Illuminate: A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: DICE Therapeutics, Inc.

New P2 trial • Dermatology • Immunology • Psoriasis

DICE Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights (GlobeNewswire) - "Results from DICE’s Phase 1 proof-of-concept clinical trial of DC-806, including additional biomarker data, were presented in a late-breaking oral session at the 2023 American Academy of Dermatology (AAD) Annual Meeting in March 2023....The first patient has been dosed in a global, dose-ranging Phase 2b clinical trial of DICE’s lead oral IL-17 inhibitor, DC-806....Continued enrollment of participants in DICE’s Phase 1 clinical trial of DC-853, a second oral IL-17 antagonist, in healthy volunteers. Topline data are expected in the second half of 2023."

Enrollment status • P1 data • Trial status • Immunology • Inflammation • Psoriasis

DC-806, an oral IL-17A inhibitor: Proof-of-concept in adults with mild-to-moderate psoriasis (AAD 2023) - No abstract available

Clinical • Late-breaking abstract • Dermatology • Immunology • Psoriasis • IL17A

DICE Therapeutics Reports Third Quarter 2021 Financial Results and Recent Highlights (GlobeNewswire) - "Dosed first healthy volunteers in Phase 1 clinical trial of oral IL-17 antagonist S011806...The Phase 1 trial is designed to generate safety and pharmacokinetic data, as well as provide early clinical proof-of-concept in psoriasis patients. The trial will be conducted in three cohorts: Phase 1a and 1b in healthy volunteers, and Phase 1c in psoriasis patients."

Trial status • Immunology • Psoriasis

Preclinical DiCE Molecules will roll its dice to Wall Street amid biotech IPO frenzy (FierceBiotech) - "DiCE Molecules wants to join the party, albeit not in Las Vegas but on Wall Street, with another preclinical biotech IPO as it goes up against psoriasis giants from Novartis, Eli Lilly and Amgen....DiCE is betting it can be the first oral therapy approved for the IL-17 target as it looks to begin a phase 1 trial in psoriasis soon and with data next year."

New P1 trial • Immunology • Psoriasis

DiCE Molecules Announces $60 Million Series C-1 Financing (Businesswire) - "DiCE Molecules...announced the completion of its $60 million Series C-1 financing. The financing was led by RA Capital Management and Sands Capital, with participation from new investors Janus Henderson Investors, Deep Track Capital and Logos Capital...With the closing of this Series C-1 financing round, the Company has raised approximately $200 million to date...Proceeds of the financing are expected to be used to support advancement of the Company’s preclinical IL-17 antagonist franchise into clinical development, advancement of preclinical α4ß7 and αVß1/αVß6 integrin programs, pipeline expansion and other general corporate purposes."

Financing • Immunology • Inflammatory Bowel Disease • Psoriasis