MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) is currently undertaking a phase 3 clinical trial of CimetrA in Israel as an investigational medicinal product for the treatment of COVID-19 following successful phase 2 trials in 2020.
COVID-19 pandemic − clinical challenges
CimetrA is a nanoparticle micellar formulation based on the pharmaceutical synergetic composition consisting of Curcumin and Boswellia.
It has anti-inflammatory and immunomodulating effects and can be designed for multiple therapeutic applications utilising Graft Polymer IP Ltd’s proprietary GraftBio Self-nanoemulsifying Drug Delivery System.
GraftBio is a unique platform used to deliver the natural active ingredients of CimetrA more effectively and in higher concentrations to cells, therefore improving their bioavailability and synergy.
MGC Pharma has entered into a worldwide licensing agreement with Graft Polymer to utilise the GraftBio delivery system for a number of MGC products including CimetrA, under which MGC pays Graft Polymer a nominal fee of €1.00 per unit sold.
CimetrA – A new investigational drug by MGC Pharma
Preclinical and clinical results to date have demonstrated CimetrA’s mechanism of action as an anti-inflammatory and immunomodulatory agent which is effective in the prevention of severe inflammation by its control of increased cytokine production which results from an infection of the different variants of SARS-CoV-2 (the virus responsible for COVID-19); and which is the forerunner of a cytokine storm, which is believed to be the main reason for mortality in severe COVID-19 patients.
Pre-clinical study: general results
The safety profile of CimetrA has been demonstrated during a number of in vitro and in vivo clinical trials undertaken in a GLP-accredited lab operated by Science in Action, a boutique preclinical contract research organisation located in Israel.
These findings are further supported by the phase 2 clinical trial undertaken by MGC Pharma in 2020, which demonstrated a full safety profile for CimetrA.
Clinical study: general results
CimetrA is currently undergoing a phase 3 clinical trial in Israel as an Investigational Medicinal Product for the treatment of COVID-19 following successful phase 2 trials in 2020.
The first patient was enrolled at the Israel trial site in July 2021.
Benefits of using CimetrA in community
In early October 2021, MGC’s US partner AMC Holdings placed its first order a little over a month after signing a supply deal worth up to US$24 million over the next three years.
The US$3 million purchase order for 110,000 units of CimetrA is the biggest single order the company has received for the product to date.
MGC managing director Roby Zomer said following the receipt of the order: "The receipt of the first year US$3 million purchase order for CimetrA from AMC firmly establishes our exciting partnership and MGC Pharma's expansion into the USA market for our unique phytomedicines.
“The agreement will provide a foundation for further clinical research and development of our products and enable access for US patients to have access to our products in the immediate future."
MGC Pharma’s regulatory strategy for CimetrA
- Pre-clinical studies according to the FDA requirements – In-Vivo (mice and rats) and In-Vitro (toxicity, satiety, efficacy) – Proof of concept (performed in Israel, ended Sep 2020 and August 2021)
- Clinical – phase 2 study (performed in three hospitals in Israel and one hospital in India, ended Nov 2020)
- Clinical – phase 2a study (performed in India, ended June 2021)
- Clinical – phase 3 study started in Israel July 2021 and ongoing
- For later-stage clinical trials, in addition to Israel, MGC will perform studies in other countries in South America, East Asia and Eastern Europe. Preliminary contacts have already been initiated
- CimetrA is currently in early stages of approval as an IMP (Investigational Medicinal Product) and under Emergency Use in USA, India, and several Eastern European countries
Saving lives and money
AMC general counsel Brent Yessin said: “The average cost of COVID-19 hospital stays in the US is $40,000, meaning for every 1,000 patients you keep out of hospital, you save $40 million and countless lives.
“Healthcare workers say they need more tools to treat people before they are so sick they need oxygen, and political leaders want to give them what they need.
“Helping US hospitals and physicians join CimetrA trials in Israel and around the world is one way AMC and MGC help patients, caregivers and thought leaders gain access to those valuable tools.”