LY3451838 / Eli Lilly - LARVOL DELTA

Pituitary adenylate-cyclase activating polypeptide (PACAP)-targeting treatment as a potential migraine prophylactic therapy (PubMed, Ideggyogy Sz) - "Results from a Phase 2a randomized clinical trial using a human mAb against the PAC1 receptor (subcutaneous AMG 301) showed no difference between placebo and the active drug in reducing the number of monthly migraine days (MMD)...A recently published Phase 2 clinical trial investigating a human mAb targeting PACAP (a single 1500 mg intravenous dose of LY3451838) showed no difference in the reduction of MMDs in patients with episodic and chronic migraine. The results of the ongoing PROCEED study, which evaluates the efficacy of four different doses of Lu AG09222 in migraine prevention, are expected to be published soon. Based on the findings from early-phase observations with mAbs against PACAP and its receptor, further high-phase clinical studies are required."

Clinical • Journal • Review • CNS Disorders • Migraine • Pain • ADCYAP1

Is PACAP the next big thing in migraine therapy? (PubMed, Cephalalgia) - No abstract available

Journal • CNS Disorders • Migraine • Pain • ADCYAP1

Preclinical and clinical evaluation of LY3451838, a PACAP-neutralizing monoclonal antibody, in randomized, double-blind, placebo-controlled phase 1 and phase 2 studies involving healthy adults and adults with treatment-resistant migraine. (PubMed, Cephalalgia) - P1, P2 | "However, the difference observed between LY3451838 and placebo among CM patients is similar to the statistically significant difference reported in the recent HOPE trial, which primarily consisted of CM patients. Further clinical research with larger sample sizes is needed to inform on the utility of blocking PACAP in various migraine populations.Trial RegistrationClinicalTrials.gov: NCT03692949 (phase 1); NCT04498910 (phase 2)."

Clinical • Journal • P1 data • P2 data • Preclinical • B Cell Lymphoma • CNS Disorders • Hematological Malignancies • Lymphoma • Migraine • Non-Hodgkin’s Lymphoma • Oncology • Pain • ADCYAP1

A Study of LY3451838 in Participants With Migraine (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed | N=120 ➔ 38

Enrollment change • Trial completion • CNS Disorders • Migraine

A Study of LY3451838 in Participants With Migraine (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Nov 2021 ➔ Sep 2022; Trial primary completion date: Nov 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Migraine

A Study of LY3451838 in Participants With Migraine (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Migraine

A Study of LY3451838 in Participants With Migraine (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: Eli Lilly and Company; Trial primary completion date: Dec 2020 ➔ Nov 2021

Clinical • Trial primary completion date • CNS Disorders • Migraine

A Study of LY3451838 in Participants With Migraine (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: Eli Lilly and Company

Clinical • New P2 trial • CNS Disorders • Migraine

A Study of LY3451838 in Healthy Participants (clinicaltrials.gov) - P1; N=53; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed; N=80 ➔ 53

Clinical • Enrollment change • Trial completion