Europe-based pharmaceutical company MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has received encouraging findings from the pre-clinical chronic toxicology evaluation of CimetrA®, showing safety when administered in large animals.
The company, which specialises in plant-derived medicines, conducted a study on 32 domestic swine that involved administering three dosage groups of CimetrA and a placebo over a 14-day period.
Clinical parameters were meticulously recorded, including blood tests comprising hematology, coagulation and chemistry, and urine samples, which were subjected to histopathological evaluation.
Important outcome
The histopathological examination revealed normal and unaffected tissues across all animals and at the administered dosage did not induce toxicological changes. No abnormalities were observed in the blood and urine samples either.
This study was executed at the GLP-certified Lab Science in Action in Ness Ziona, Israel.
The outcomes are a crucial component of the company’s Investigational New Drug (IND) submission to the US Food and Drug Administration targeted for the first quarter of 2024.
Key achievement
“We are delighted with the positive clinical trial results for CimetrA which paves the way for our IND submission to the FDA next year,” MGC Pharmaceuticals chief executive officer and managing director Roby Zomer said.
“The potential addressable market for our anti-inflammatory and immunomodulating product is considerable and this represents a key milestone for the business.”
CimetrA stands as a nanoparticle micellar formulation, comprising curcumin and boswellia, known for their anti-inflammatory and immunomodulating properties in clinical trials.