Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCMKTS:NSPDF) said Friday that it was “encouraged” by the communication and support shown by Health Canada and expects more direction “shortly” on its application for a Phase 2 trial of Cavaltinib as a treatment for coronavirus (COVID-19).
A clinical trial application (CTA) was approved for submission to Health Canada on May 17. The drug directorate moved the application along the path for review and asked for more information. In response, the company submitted a set of documents at the start of June.
Once again, additional documentation was requested by Health Canada and was speedily added by the company to the original application on June 15.
“We are encouraged by the communication and facilitation support by Health Canada and anticipate more direction by Health Canada shortly,” the company said in a statement.
Cavaltinib is licensed to a joint venture owned by Naturally Splendid and Biologic Pharmamedical Research based on technology and patents developed by Biologic.
The Cavaltinib drug candidate 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 critically ill COVID-19 patients.
“Biologic Pharmamedical's work has historically shown the drug's activity to be successful in this context leading to Health Canada's interest and support to facilitate the CTA,” said the company.
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.
The company said it has “aggregated new members of the scientific advisory team to expand its resource and expertise base in line with this objective.”
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive