MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has completed a key regulatory step in the development of CimetrA™, successfully concluding a full pre-clinical rodent study panel for the potentially anti-inflammatory and immunomodulating therapy.
The company used research carried out on rodent and mammalian models to define the treatment’s pharmacokinetic profile and general safety of the drug – in other words, measuring absorption, distribution, metabolism and excretion patterns within an animal model.
These studies also aimed to meet a key US Food and Drug Administration (FDA) requirement with the identification of toxicity patterns over a given period of treatment – 14 days in this case.
The study involved four study groups – one control group and three separate dosage groups. Treatment was administered over the 14-day period, followed by a 7-day review period.
MGC Pharma and its laboratory partner found no anomalies within the biopsies taken nor did researchers note any clinical or behavioural adverse events.
Advancing toward clinical trials
“The successful completion of this study and the excellent results attained is an important milestone moment for the company, as we continue to progress CimetrA along the mandated clinical pathway,” MGC Pharma co-founder, managing director and CEO Roby Zomer said.
“The results of this study are a critical step in advancing MGC’s submission to the FDA and for the final approval of CimetrA as an Investigational New Drug (IND) in the US.”
There is a strict process for FDA approval: discovery, preclinical development and clinical trial, where the boundary between preclinical development and clinical trial is sharply defined by the IND approval.
IND application approval would grant MGC Pharma a technical exemption from the FDA’s drug distribution regulations and allow CimetrA to be shipped to clinical investigators across the US for clinical trials.