Amilo-5MER / Galmed, Hebrew University of Jerusalem - LARVOL DELTA

A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Galmed Pharmaceuticals Ltd

New P1 trial • Inflammation

Galmed announces positive results of Phase 1 study of Amilo-5MER (PRNewswire) - "Galmed Pharmaceuticals Ltd...announced today results of a Phase 1 clinical trial of Amilo-5MER in healthy volunteers that demonstrated an excellent safety profile and tolerability...Plasma concentrations of Amilo-5MER increased in proportion to dose...The Company plans to submit an IND for mild to moderate ulcerative colitis in 2022."

IND • P1 data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MTADV 5-MER peptide suppresses chronic inflammations as well as autoimmune pathologies and unveils a new potential target-Serum Amyloid A. (PubMed, J Autoimmun) - "5- MER peptide (5-MP) MTADV (methionine-threonine-alanine-aspartic acid-valine), also called Amilo-5MER, was originally derived from a sequence of a pro-inflammatory CD44 variant isolated from synovial fluid of a Rheumatoid Arthritis (RA) patient...5-MP could not display therapeutic activity in rats, which are SAA deficient, but does inhibit inflammations in animal models of IBD and MS, both are SAA-dependent, as shown by others in SAA knockout mice. In conclusion, 5-MP suppresses chronic inflammation in animal models of RA, IBD and MS, which are SAA-dependent, but not in animal models, which are SAA-independent."

Journal • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Multiple Sclerosis • Rheumatoid Arthritis • Rheumatology • CD44 • IL1B

Galmed Pharmaceuticals Announces Publication in The Journal of Autoimmunity for its IND ready, Amilo-5MER, a specific anti-inflammatory compound (BioSpace) - "Galmed Pharmaceuticals...announced today the publication in The Journal of Autoimmunity for its IND ready compound, Amilo-5MER...This human peptide displays an efficient anti-inflammatory effect to ameliorate pathology and clinical symptoms in mouse models of RA, inflammatory bowel disease (IBD) and multiple sclerosis (MS)."

Preclinical • Inflammatory Bowel Disease

KOL Symposium and Pipeline Update (Galmed Pharma) - "26 January 2021, 11:00 AM, The symposium will feature KOL Arun Sanyal....The event will provide a detailed overview of Galmed's two pipeline assets, Aramchol in Phase 3 for NASH and fibrosis and Amilo-5MER in development for chronic inflammatory disorders. A Q&A session will follow the formal presentations."

Live event

Galmed Pharmaceuticals Announces Dosing of First Subject in First in Human Phase 1 Trial of Amilo-5MER (PRNewswire) - "Galmed Pharmaceuticals Ltd...announced the treatment of the first subject in the First-in-Human Phase I clinical trial evaluating Amilo-5MER for the treatment of chronic inflammatory diseases. Additional subjects enrollment to the study is ongoing...Amilo-5MER's Phase I trial is a three-part, single center, double-blind, randomized, placebo-controlled first in human study of single ascending doses (Part 1) and multiple doses (Part 2) of Amilo-5MER in young healthy male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3)."

Trial status • Inflammatory Bowel Disease • Rheumatoid Arthritis