simepdekinra (LY4100511) / Eli Lilly - LARVOL DELTA

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jun 2024

Trial completion • Trial completion date

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC-853 in Healthy Participants (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Eli Lilly and Company

New P1 trial

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=69 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Completed

Trial completion

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 of LY4100511 (DC-853) Mass Balance and Absolute Bioavailability of LY4100511 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Completed | N=16 ➔ 24

Enrollment change • Trial completion

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Completed

Trial completion

A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | N=32 ➔ 48 | Trial completion date: Oct 2024 ➔ Dec 2024 | Trial primary completion date: Oct 2024 ➔ Dec 2024

Enrollment change • Trial completion date • Trial primary completion date

A Study of LY4100511 (DC-853) Mass Balance and Absolute Bioavailability of LY4100511 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of LY4100511 (Dice 853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P2 trial • Dermatology • Immunology • Psoriasis

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Dec 2024

Enrollment closed • Trial completion date

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=77 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | N=59 ➔ 77 | Trial completion date: Jul 2024 ➔ Nov 2024 | Trial primary completion date: Jul 2024 ➔ Nov 2024

Enrollment change • Trial completion date • Trial primary completion date

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Cytochrome P450 3A4 and 2C8 Substrates in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=59 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting | N=30 ➔ 59

Enrollment change • Enrollment open

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

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

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