Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCMKTS:NSPDF) announced Wednesday that Health Canada has approved a Phase 2 clinical trial of Cavaltinib to treat the COVID-19 disease caused by SARS-CoV-2 coronavirus.
The clinical trial design protocol, which will look at the drug’s efficacy over a 30-day period, was submitted through a proposed joint venture with Biologic Pharmamedical Research. Cavaltinib already is licensed to another JV owned by Naturally Splendid and Biologic Pharmamedical based on technology and patents developed by Biologic.
"We are optimistic that Cavaltinib can be a major part of a successful treatment plan for COVID-19 positive patients,” said Franco Cavaleri, CEO and chief scientist at Biologic Pharmamedical, in a statement.
READ: Naturally Splendid Enterprises updates on clinical trial application for Cavaltinib to treat coronavirus
“With this treatment option for those who are at high risk of morbidity or mortality we may be able to provide hope while reducing the impact on Health Care Services and thus providing additional time for the scientific community to develop the right vaccines,” Cavaleri added.
The drug has been shown to inhibit small proteins released by cells called cytokines that are central to the “cytokine storm” phenomenon, where the body starts to attack its own cells rather than just fighting off the virus as seen in critically ill COVID-19 patients.
"Cytokine storms are a common complication not only of COVID-19 but of other respiratory diseases caused by coronaviruses such as SARS and MERS,” Cavaleri said.“In fact, this mechanism of disease development is also similarly central to autoimmune and autoinflammatory diseases."
New JV called Plasm Pharmamedical Inc
Meanwhile, Naturally Splendid said the agreement for the second JV with Biologic Pharmamedical for the COVID-19 clinical trial to be called Plasm Pharmamedical Inc (PLASM) is being finalized and expected shortly.
Biologic will license certain aspects of the patent comprising of the corresponding trademark Cavaltinib to PLASM. The categories to be licensed will include, but not be limited to COVID-19 applications, as well as respiratory indications that may come out of the fast-tracked clinical trial.
Naturally Splendid said it will invest $500,000 into the PLASM JV for the purpose of supporting the Phase 2 trial as well as research identifying additional indications of treatment. It will own 16% of the joint venture and receive a 10% royalty on the gross sales of all product sales by the JV.
“We are optimistic that Cavaltinib can be a viable treatment,” said Naturally Splendid VP of Operations Bryan Carson.
“However, we must also not lose sight of the fact that respiratory disease overall is on the rise as our environment evolves and infectious diseases become more pervasive. Although our immediate focus remains a treatment for COVID-19, the applied science that we stand to learn from these trials may have even far more reaching implications in regards to treatment for respiratory disease than our initial goal to mitigate the health implications of COVID-19".
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