MGC Pharmaceuticals' interim results of its novel formula 'ArtemiC' have "demonstrated significant improvement in patients infected with COVID-19."
MGC Pharmaceuticals (ASX:MXC) has just released more interim analysis results from its phase II double-blind, placebo-controlled clinical trial on the company's novel anti-inflammatory formula known as 'ArtemiC.'
The results met all the study protocols primary objectives, most notably by demonstrating a significant clinical improvement in patients infected with COVID-19 who use ArtemiC.
These results build upon prior successes for MGC Pharma in recent weeks, with ArtemiC showing no adverse reactions in animal trials, reduced cytokines in "in-vitro" studies as well as reducing the likelihood of COVID-19 patients to suffer from a "cytokine storm," which is one of the major causes of fatality for those who catch the virus.
As the announcement states: "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."
By reducing the prevalence of cytokine storms, MGC has announced that its recent interim analysis results on ArtemiC met the "FDA's recommended primary endpoint" which involves achieving a "sustained clinical recovery, the resolution of symptoms and preventing the need for intensive care or invasive mechanical ventilation."
Moreover, the trials showed that ArtemiC had no adverse effects on the treatment group, while also achieving a significant improvement in conditions. By reducing the severity of conditions felt by COVID-19 patients, MGC Pharma believes that ArtemiC may help to "relieve the pressure on global healthcare systems caused by COVID-19."
The interim analysis was done for a double-blind placebo-controlled Phase II ArtemiC trial involved ten (10) patients that had been recruited and completed at Nazareth Hospital EMMS and Hillel Yaffe Hospital, and the severity of symptoms experienced by patients was assessed using the National Early Warning Score (NEWS). The NEWS Score is used to standardize the detection of, and response to acute illnesses by hospitals.
In the recent announcement, MGC states that the treatment group who were given ArtemiC instead of a placebo all reported higher NEWS scores prior to treatment, with four people having a NEWS score between 8-11, indicating a high level of severity in symptoms. Conversely, the placebo group had lower NEWS scores upon entry to the trial, indicating a lower severity of COVID-19 symptoms.
Despite this, MGC reports that all participants in the treatment group had NEWS scores of 0 upon completion of the 15-day trial, compared with the placebo group in which one patient's NEWS score increased from 2 to 16, indicating a significant deterioration and a high likelihood for ICU admission. This NEWS Score decreasing was statistically significant (p<0.05)
In layman's terms, the patients who used ArtemiC reported a significantly lower pain severity from COVID-19 than those that were given a placebo, affirming prior results that suggest the efficacy of MGC's ArtemiC in treating COVID-19 and lowering the rate of ICU admissions in patients.
On future ArtemiC trials, the company stated that "all information obtained from the interim data from the Phase IIa trial will serve the Company to design Phase IIb and Phase III clinical trials, with the trial protocols, procedures and endpoints to be defined based on the preclinical studies and Phase IIa results."
Comments from Management
Dr Elias Hillou, Investigator for the Clinical Trial from Hille Yaffe Medical Centre commented on the interim ArtemiC trial results:"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 is very promising. Dr Elias Hillou, Investigator for the Clinical Trial from Hille Yaffe Medical Centre
Dr. Hillou went on to say that "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."
Dr Nadya Lisovoder, Chief Research Officer of the Phase IIa trial and CEO of Galilee Clinical Bio Research , commented:
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.
Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: "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."
To learn more about MGC Pharma, visit the company HQ here.
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