Candidate: CavaltinibTM

Type: Inhibitor of IL-6 and several cytokines central to the “cytokine storm” phenomenon

Status: Naturally Splendid Enterprises (NSE) said May 21 that Health Canada had performed an initial review of data for a Clinical Trial Application (CTA), and advised that the Biologic Division within the Health Canada Office of Regulatory Affairs Biologic and Radiopharmaceutical Drugs Directorate was the appropriate channel to which the completed CTA can be submitted for processing. That designation creates a clear path for the CTA to proceed, the company said.

The study will apply an adaptive pilot to pivotal trial design to determine if Cavaltinib is a viable treatment that can improve clinical symptoms, and can reduce the number of COVID-19 infected patients from progressing to mechanical ventilation with intubation and death.

The trial will begin as a Phase II study and advance into a Phase III trial if preliminary data is found to be positive. The Phase II portion of the study is expected to last four weeks, which will include monitoring of patients and correlating of the data.

Biologic Pharmamedical and NSE have formed a joint venture to develop Cavaltinib, based on technology and patents developed by Biologic. Cavaltinib has been run through Biologic’s research program, designed to study key drug targets involved in the regulation of immune system and inflammatory activity.

That research, according to the companies, has shown that Cavaltinib “irrefutably” inhibits IL-6 and several other cytokines central to the ‘cytokine storm’ phenomenon. However, Cavaltinib has yet to be prove in a clinical setting that mitigation of the ‘cytokine storm’ will show the same positive results with COVID-19 patients. Biologic has a parallel trial that has drawn participation from an undisclosed “major” university in the U.S.

Biologic and NSE said their joint venture will be granted rights from Biologic’s patents to applications for treating COVID-19 infections. Categories to be licensed will include COVID-19 applications, as well as additional respiratory indications that may arise out of the fast-tracked Phase II clinical trial.

COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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