Regulators clear Cytocom to launch Phase II study of COVID treatment

FORT COLLINS — The U.S. Food and Drug Administration has granted Cytocom Inc. permission to begin a Phase II trial of a drug candidate it believes could treat patients with symptomatic COVID-19.

Study Information provided to regulators shows that Cytocom intends to recruit 75 participants and anticipates starting the trials next month at a hospital in California. The Fort Collins company anticipates completing the study next April.

The drug being studied is naltrexone hydrochloride, a similar compound to Narcan that is used to treat alcohol and drug addiction at doses between 50 to 100 milligrams. Cytocom believes that naltrexone issued at 4.5 milligram doses can restrict a patient’s immune system from overreacting to the COVID infection and reduce the inflammation that is thought to cause serious harm to certain patients.

Although the world is slowly exiting from the pandemic thanks to mass-vaccination efforts, COVID-19 treatments will remain a necessary tool in the future to treat COVID patients who refuse to get a vaccine or cannot get a vaccine due to allergies or pre-existing conditions.

“Even as new vaccines are introduced into the market and inoculation programs continue to expand, the need for safe and effective therapies to treat COVID-19 remains undiminished, especially in light of the spread of new, highly contagious variants of the virus,” CEO Michael Handley said in a statement.

Cytocom is betting that naltrexone hydrochloride at low doses can modulate a patient’s immune system and treat ailments such as Crohn’s Disease, fibromyalgia and multiple sclerosis. Those three illnesses are thought to be caused by an overactive immune system attacking healthy cells within the body.

The company is in the midst of acquiring Cleveland BioLabs Inc. (Nasdaq: CBLI) in a reverse-merger deal that would take it public. The deal is expected to close this spring.

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