MGC Pharma’s CimetrA® in pigs supports previous data in an important step for its planned IND submission with the US FDA.
MGC Pharma hits another milestone in path to FDA approval for anti-inflammatory CimetraA
Health & Biotech
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Positive results from pre-clinical chronic toxicology evaluation of MGC Pharma’s CimetrA® in pigs supports previous data in an important step for its planned IND submission with the US FDA.
European based Biopharma MGC Pharmaceuticals (ASX:MXC) (LSE:MXC) has announced
positive pre-clinical trial results from its recently completed pre-clinical chronic toxicology evaluation of 14 days oral dose of lead drug candidate CimetrA®.
The recently completed study was undertaken on 32 domestic swine, that received a study treatment (three dosages groups of CimetrA® and placebo) for 14 days.
During this period, the clinical parameters were recorded, including blood (hematology, coagulation, and chemistry) and urine tests collected and sent to the histopathological evaluation.
The study demonstrated that following the full chronic safety and toxicology analysis of CimetrA® in large animals – the drug was found to be safe.
The histopathological analysis of the full organs’ spectrum demonstrated all tissues of the animals were normal and unaffected.
It was concluded that the test article at the dosage administered did not induce toxicological changes. No changes in the blood and urine samples were reported.
Seeking FDA IND approval in 2024
The study was performed under animal EC approval in the GLP certified Lab Science in Action, Ness Ziona, Israel, and is an important step in the Investigational New Drug (IND) submission preparation for the US Food and Drug Administration (FDA).
The study was designed and managed according to industry guidelines and the IND submission is planned for Q1 2024.
CEO and managing director Roby Zomer says the company was delighted with the positive clinical trial results for CimetrA® which paves the way for its IND submission to the FDA next year.
“The potential addressable market for our anti-inflammatory and immunomodulating product is considerable and this represents a key milestone for the business,” he says.
Meanwhile, MXC recently received a vote of confidence in ArtemiC after receiving a second order worth US$1m for the over the counter anti-inflammatory and treatment for moderate Covid-19 from AMC Pharma.
This article was developed in collaboration with MGC Pharmaceuticals, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
