Biopharma company MGC Pharmaceuticals (ASX:MXC) has confirmed the successful results of its second phase clinical trial for its anti-inflammatory medicine for the treatment of COVID-19 in patients.

The company satisfied all of the primary and secondary endpoints of its Phase II clinical trial for the phyto-cannabinoid treatment that saw a 100 per cent recovery rate among the trial’s 50 participants.

“The safety and efficacy demonstrated on COVID-19 patients has now opened the opportunity for a whole range of other indications related to cytokine storm,” said company co-founder and managing director, Roby Zomer.

He said the trial results provide a ‘transformational opportunity’ for the company which is serving a growing patient base in Australia, Brazil and the UK.

Initial results of the Phase II clinical trial were released last month, and now the full results have been published and confirm the trial has been a success.

The treatment is shown to be effective in reducing inflammation symptoms associated with the human body’s cytokine storm immune response, and it has application in a wide range of illnesses including autoimmune diseases and in chemotherapy.

Phase III clinical trial planned for early 2021

MGC Pharma plans to move to a Phase III clinical trial for its anti-inflammatory treatment on COVID-19 diagnosed patients in early 2021, and once satisfactory, begin production of the medicine at its company facilities under a new brand name.

The Phase III trial is expected to include a larger study group of 250 patients in several international locations and will investigate its application in a wide range of inflammatory illnesses and conditions.

Regulatory approvals to start Phase III trials for the treatment are expected to be made in early 2021 by medical authorities in Brazil and Europe.

The anti-inflammatory treatment uses the Swiss PharmaCan AG MyCell Enchanced delivery system technology, and was shown to improve the clinical recovery of patients diagnosed with COVID-19.

The Phase II clinical trial was a double-blind study that met all of the Food and Drug Administration requirements for a COVID-19 study, including population diversity.

It involved 50 COVID-19 infected patients at three hospital sites in India and Israel.

Furthermore, none of the patients in the trial required additional oxygen, mechanical ventilation or admission to intensive care, compared to 23 per cent of the comparison group in the study that received a placebo.

No adverse effects in COVID-19 patients in study

The study showed patients experienced no adverse events, and the anti-inflammatory treatment prevented any deterioration in their condition and reduced the pressure on medical systems.

The clinical study’s results are supported by in vitro and in vivo studies, demonstrating the mechanism of action and safety profile of the anti-inflammatory treatment.

Earlier studies for the anti-inflammatory treatment included tests for safety and toxicity completed on mice and rodents in line with FDA practice.

MGC Pharma has highlighted the positive impact its phyto-cannabinoid formulations can have in the treatment of patients with a range of illnesses including glioblastoma, an aggressive form of brain cancer.


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