Benzinga | Jan 10, 2022 07:46AM EST

Galmed Announces Results Of Phase 1 Study Of Amilo-5MER Demonstrating Safety And Tolerability

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today results of a Phase 1 clinical trial of Amilo-5MER in healthy volunteers that demonstrated an excellent safety profile and tolerability.

Amilo-5MER is a synthetic peptide consisting of 5 amino acids that significantly reduces symptoms and histopathological hallmarks of IBD in animal models (TNBS, DSS). TNBS and DSS are well-established and widely recognized models of acute colitis. Amilo-5MER also showed anti-inflammatory effects in animal models of multiple sclerosis and rheumatoid arthritis. Amilo-5MER exerts its anti-inflammatory effects by binding with high affinity to pro-inflammatory amyloid proteins, preventing polymerization of Serum Amyloid A (SAA) monomers and thereby interfering with SAA-induced immune cell activation.

The safety, tolerability, and pharmacokinetics of single and multiple doses of Amilo-5MER were assessed in a first-in-human study in healthy subjects. The Phase I study was conducted in a single-center, using a double-blind, randomized, placebo-controlled design. Overall, 64 healthy male and female subjects were enrolled in the study. Cohorts of 8 subjects were randomized to receive Amilo-5MER or placebo by subcutaneous injection in a ratio of 6:2. In Part 1, cohorts of young male adults received single ascending doses of 10, 30, 90, 180 and 360 mg; in Part 2, a single cohort received doses of 180 mg BID for 5 consecutive days and in Part 3 a single cohort of healthy elderly male and female subjects received a single dose of 180 mg.

All doses of Amilo-5MER were well tolerated with no clinically significant adverse events and none considered related to the investigational product. All subjects completed the study as per protocol. Plasma concentrations of Amilo-5MER increased in proportion to dose.

Prof John Posner Visiting Professor, School of Life Sciences & Medicine, King's College London who served as medical monitor commented, "Serum Amyloid A is an important inducer of inflammation and Amilo-5MER has real potential to serve as a first in class, specific anti-inflammatory agent with multiple disease indications. It also has the potential to inhibit cytokine release syndrome."

"We are excited to bring Amilo-5MER into the clinical phase and look forward to advancing our product pipeline to address additional important indications for the benefit of patients around the world," noted Allen Baharaff, President and CEO of Galmed. Galmed is developing Amilo-5MER for multiple routes of administration and multiple indications. The Company plans to submit an IND for mild to moderate ulcerative colitis in 2022.