Revive Therapeutics (CSE: RVV) this morning announced that it has received approval from the Independent Institutional Review Board (IRB) for an expanded access protocol for compassionate use of Bucillamine in the treatment of COVID-19. The compassionate use protocol is being completed to complement Revive’s Phase 3 study for the treatment of COVID-19.
The expanded access protocol that has now been approved is a multi-center open label study of hospitalized patients with severe COVID-19, where Bucillamine is to be used as a treatment option to treat the disease. The company currently expects patients will be enrolled in the program later this month.
The expanded access protocol essentially exists as an option for patients whom are not currently eligible for inclusion criteria for Revive’s phase 3 clinical study. The data collected from the program however is said to be valuable in supporting the clinical development of Bucillamine.
“With the IRB approval of the expanded access protocol by Advarra, a premier IRB services company in North America, hospitalized patients with severe COVID-19 may access Bucillamine under the FDA compassionate use program under medical supervision by their physician.”
Michael Frank, CEO Revive Therapeutics
Under the protocol, physicians will be granted access to utilize Bucillamine in the treatment of COVID-19 through the existing investigational new drug status that the company has acquired. The program will see patients receive three 200mg doses of Bucillamine a day for a period of up to fourteen days. Follow ups will be completed by a study nurse 14 days and 42 days following the end of treatment to further analyze the results.
Revive Therapeutics last traded at on the CSE.
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