Phase-two clinical trials show MGC Pharmaceuticals’ (ASX:MXC) medical spray is a safe and effective anti-inflammatory treatment for patients with COVID-19.

Statistically significant results from the clinical trial demonstrate that MGC’s anti-inflammatory medicine meet US Federal Drug Administration guidelines for COVID-19 treatments, the company said.

The phase-two clinical outcome is consistent with an earlier pre-clinical study that showed patients treated with MGC’s anti-inflammatory medicine had a reduction in their immune system’s inflammatory response to the virus, known as a cytokine storm.

“We are very pleased with the phase-two interim results of the medicine which have so far met all primary endpoints while also demonstrating safety of the treatment on the initial 10 patients,” co-founder and managing director Roby Zomer said.


Effectiveness of anti-inflammatory treatment shown on human cells

MGC Pharma said the two studies results were important as they confirmed the effectiveness of its anti-inflammatory treatment on human immune cells.

The results mean that patients exhibiting COVID-19 symptoms can be treated before they need to be admitted to hospital as in-patients, relieving pressure on healthcare systems.

US Federal Drug Administration guidelines for COVID-19 clinical trials require patients to show a sustained recovery, a resolution of symptoms, and the prevention of intensive care or invasive ventilation for high-risk patients.

Patients treated in the double-bind, placebo-controlled clinical trial did not show any adverse events, and made a significant improvement, according to the statistically proven study.


Hospital-based research study findings

An initial 10 patients were recruited to the phase-two clinical trial at Nazareth and Hillel Yaffe hospitals in Israel to assess the effect of MGC Pharma’s medicine on COVID-19 patients.

Four of the patients entered the clinical study with higher than average disease severity and responded well to treatment, as did others in the study, and were discharged symptom free.

An additional 19 patients are currently participating in further clinical trials and the number will eventually reach a maximum of 50.

Dr Nadya Lisovoder, chief research officer of the phase-two trial and chief executive of Galilee Clinical Bio Research, said the project demonstrated it had the potential to help with the treatment of COVID-19 infected patients.

MGC Pharma will start designing protocols and parameters for a phase 2B follow-up clinical trial and prepare production of its anti-inflammatory medicine.

The company recently announced a UK distribution partner for its medicinal cannabis products.

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