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Naturally Splendid Enterprises submits application to Health Canada for Phase 2 coronavirus trial

The drug is licensed to a joint venture owned by Naturally Splendid and Biologic Pharmamedical Research

Naturally Splendid Enterprises Ltd. -
The Phase 2 portion of the study is expected to last four weeks, which will include monitoring of patients and correlating the data

Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCMKTS:NSPDF) said an application for a Phase 2 trial of Cavaltinib as a treatment for coronavirus (COVID-19) has now been submitted to Health Canada, sending shares higher.

As previously announced, the drug is licensed to a joint venture owned by Naturally Splendid and Biologic Pharmamedical Research based on technology and patents developed by Biologic.

READ: Naturally Splendid advances clinical trial preparation for Cavaltinib to treat coronavirus patients

The drug candidate, which features curcumin, has been through a research program designed to study key drug targets involved in the regulation of immune system and inflammatory activity.

Cavaltinib has been shown to inhibit IL-6 and several other cytokines central to the 'cytokine storm' phenomenon, where the body starts to attack its own cells rather than just fighting off the virus, seen in COVID-19 patients.

"The trial will begin as a Phase 2 study and after an interim analysis is performed on the first 40 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial," said Naturally Splendid

"The Phase 2 portion of the study is expected to last 4 weeks, which will include monitoring of patients and correlating of the data."

If preliminary data is positive, the trial would move directly from a Phase 2 trial into Phase 3.

Naturally Splendid said the same study protocol for a clinical trial was also being prepared to submit to the US Food and Drug Administration.

Shares in Toronto shot up over 18% in early deals to C$0.065.

Contact the author at [email protected]

Quick facts: Naturally Splendid Enterprises Ltd.

Price: 0.05 CAD

TSX-V:NSP
Market: TSX-V
Market Cap: $9.21 m
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