MGC Pharma (MXC) Shares Rallied 21% on Pre-Clinical Rat Study

The MGC Pharmaceuticals Ltd (LON: MXC) share price rallied 21% after completing the full pre-clinical rodents study panel for CimetrA^TM. The successful study was conducted at the  Smart Assays laboratory in Israel.

Investors cheered the announcement, given that CimetrA^TM is the company’s most clinically advanced drug candidate. MGC Pharma is planning to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).

The pre-clinical study also included the development of bioanalytical methods and validations for further pharmacokinetic analysis for CimetrA^TM. In addition, the full-safety profile for CimetrA^TM across all study dosage groups was demonstrated using histopathology. 

Science in Action, Israel, also studied chronic toxicity in rodents while monitoring the potential emergence of adverse effects from using CimetrA^TM. The biopsies collected did not have any observable anomalies, nor did the researchers record any clinical or behavioural adverse events.

The study was conducted over 14 days in rats and was a collaboration between the two laboratories. There were four study groups, three dosage groups and one control group. There was a seven-day review period following the 14-day dosage period. 

MGC Pharma noted that the study results marked a significant milestone towards submitting an IND application to the US FDA. CimetrA^TM  has previously demonstrated anti-inflammatory and immunomodulating properties. 

The company is now looking forward to submitting an Investigational New Drug (IND) application that incorporates the data collected from the recent pre-clinical study to the US Food and Drug Administration (FDA). 

The drug’s approval in the US would open up a lucrative market for the Euroepan-based company once the drug is ready for commercialisation. However, CimetrA^TM must pass the human clinical trials phase before being available commercially. 

Roby Zomer, MGC Pharmaceuticals, Co-founder and CEO, commented: “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^TM along the mandated clinical pathway. The results of this study are a critical step in advancing MGC's submission to the FDA and for the final approval of CimetrA^TM as an Investigational New Drug in the US.”

*This is not investment advice. 

MGC Pharma share price.

The MGC Pharma share price rallied 21.05% to trade at 0.69p, from Monday’s closing price of 0.57p.