MGC Pharmaceuticals Ltd (ASX:MXC) (OTCMKTS:MGCLF) has taken another step towards commercialising its anti-inflammatory treatment ArtemiC with positive interim results from a Phase II clinical trial on COVID-19 infected patients.
The Phase II double-blind, placebo-controlled clinical trial has met all the primary objectives, with all 10 patients showing significant improvement.
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These results met with the US Food and Drugs Administration’s (FDA) primary endpoint - sustained clinical recovery, resolution of symptoms and prevented the need for intensive care or invasive mechanical ventilation.
This is in accordance with FDA guidelines on the inclusion criteria for the treatment of high-risk, COVID-19 infected patients.
No adverse events
The statistically proven results show two important clinical outcomes - a significant improvement in clinical parameters of patients in the treatment group and secondly that no adverse events occurred, demonstrating the safety of the treatment in humans.
The European-based bio-pharma company specialising in the production and development of phytocannabinoid-derived medicines will submit the interim analysis results to the Ethics Committee at Hillel Yaffe Hospital and Nazareth Hospital EMMS.
These facilities, which are both in Israel, are the trial sites.
Commercialisation step
These results are a key step towards commercialisation and the next Phase IIb trials for which MGC Pharma has started designing protocols and parameters.
Results are from 10 patients treated in the trial with 19 additional patients recruited and 21 patients still to be treated to complete the trial.
MGC Pharmaceuticals co-founder and managing director Roby Zomer said: “We are very pleased with the Phase II interim results of ArtemiC which have so far met all primary endpoints while also demonstrating safety of the treatment in humans.
“These results combined with our recent preclinical results are important for designing the protocols and markers for our next Phase IIb clinical trial.
“We look forward to updating the market as we continue to receive results of this trial.”
Findings
The statistically proven results show two important clinical outcomes:
- A significant improvement in the clinical parameters of patients in the treatment group; and
- No adverse events occurred, demonstrating the safety of the treatment.
The results are consistent with the results from the preclinical in-vivo study, which demonstrate a reduction in the excessive inflammatory response known as cytokines storm.
These interim results, when combined with the results of the in-vitro study that confirm the effectiveness of ArtemiC on human immune cells to inflammatory stimuli, support expectations for desirable future results of the trial and a positive effect of the treatment.
The targeted clinical application of ArtemiC, is to effectively treat the symptoms of COVID-19 patients prior to them requiring hospital admission or alternatively shorten their stay as inpatients, and thus relieve the pressure on global healthcare systems caused by COVID-19.
Galilee Clinical Bio Research CEO and chief research officer of the Phase IIa trial, Dr Nadya Lisovoder said: “We are very happy to be a part of this important project that has demonstrated it has the potential to help with treatment of COVID-19 infected patients and have positive implications for health management in the current global pandemic we are dealing with today.”
NEWS Score
Four of the actively treated participants entered the study with a NEWS2 score of between 8 and 11, which are classified as ‘high’.
All participants in the treatment group responded well and had scores of 0 on day 15, the final day of the trial.
Change in NEWS score outcome, comparison between Placebo and Treatment study groups.
Although the study group had significantly higher NEWS score in admission, all patients had NEWS score=0 at discharge (significant reduction: P=0.005), while only two patients in the placebo group had NEWS score=0.
One patient in the placebo group had significant deterioration of the NEWS score: from 2 in admission to 16 at discharge to another hospital. The predictive value of NEWS2 scores in the context of COVID-19 is being debated, however, some data suggest that scores above 7 are highly predictive of ICU admission.
In addition, the toxicity study results recently published support the definition of maximum tolerated dose and dose-finding process, which will be required as a part of the research and development process by the regulatory authorities.
Cytokine Storm
Current clinical evidence in COVID-19 patients indicate that the Cytokine Storm is an uncontrolled over-production of soluble markers of inflammation which, in turn, sustain a systemic inflammatory response, and is a major factor responsible for the occurrence of Acute Respiratory Distress Syndrome – the main mortality reason in COVID-19 patients.
ArtemiC is being tested in a clinical trial where some of the participants may be affected by a Cytokine Storm, with interim patient statistical analysis of this Phase II clinical trial analysing the patient’s response to these conditions.
Results “very promising”
Hillel Yaffe Medical Centre investigator for the clinical trial, Dr Elias Hillou, said: “At our hospital, we have had experience in treating COVID-19 patients as one of the leading treatment hospitals in Israel, and unfortunately we have had recurring disappointment with patients deteriorating, with no tools at our disposal to treat this effectively.
“As noted from the interim analysis for the first 10 patients, these preliminary results regarding the safety and the efficacy of ArtemiC for the treatment of COVID-19 patients are very promising.
“We see no deterioration in the clinical situation, for patients who had received the real medication, as expressed by the NEWS score, compared to the group of the placebo group, that had a massive deterioration with one patient near to death, and a need for an ECMO.
“Our aim is to treat 50 patients according to the well-designed clinical research protocol to hopefully demonstrate ArtemiC is safe and efficient for COVID-19 pandemic battle and helping with effective treatment of infected patients.”
These results combined with the pre-clinical results support a high probability of success of the study in determining a safe and effective treatment for the symptoms of COVID-19.
