LOS ANGELES--(BUSINESS WIRE)--Turn Therapeutics, a biotechnology company specializing in advanced wound care and infection control, today announced the initiation of a two-part, four-arm, human safety and efficacy trial for its flagship product, Hexagen, to be used in the fight against COVID-19. This randomized, placebo-controlled trial will enroll approximately 100 mild to moderate COVID-19 patients and 50 healthcare workers across four leading hospitals in Panama, including internationally recognized Gorgas Memorial Institute of Health Studies (GMH), which will also serve as the central laboratory for sample analysis.
The treatment arms will assess the efficacy of a five-day, three time per day nasal decolonization protocol in reducing viral load and symptom progression of mild to moderate COVID-19 patients. The prevention arms will assess Hexagen’s ability to prevent COVID-19 infection in frontline workers when worn intranasally as an adjunct to personal protective equipment. With authorization from Gorgas Memorial Institute of Health Studies, Hospital Santo Tomas, Caja de Seguro Social, Hospital Integral Panamá Solidario, and the Panamanian Department of Health, the trial is slated to begin enrollment immediately with an initial data read out expected February 2021.
“Independent literature has confirmed that SARS-CoV-2 targets the nose, and that the nose is the highest source of viral shedding,” said Dr. Julio Sandoval, the studies’ lead investigator. “Reducing viral load will not only decrease the likelihood of severe illness in the carrier, but may lessen environmental spread via reduced shedding. We must remember that vaccines have not been confirmed to prevent spread. People may still be a carrier and spreader even if vaccinated.”
After receiving promising data demonstrating Hexagen’s efficacy against human coronaviruses, Turn Therapeutics has worked with leading international researchers to create and execute a protocol that would document clinical improvement in patients, as well as showcase its preventive capabilities in frontline workers when used as an adjunct to personal protective equipment. Hexagen is not yet authorized for use specifically as a COVID-19 countermeasure, but the company plans to request Emergency Use Authorization from domestic and international health authorities pending the results of this study.
“While those who receive a vaccination may be protected if exposed, vaccines are not the end of this disease,” said Bradley Burnam, CEO of Turn Therapeutics. “There is so much of the world that will wait for years to be vaccinated; some may never even have the chance. We are grateful to Dr. Sandoval and the entire research team for recognizing the importance of identifying and researching affordable, readily available therapeutics that may add to the clinical toolbox for those on the front lines.”
Hexagen is an FDA cleared advanced wound product that has been used at key opinion leading institutions in the United States since 2015. It is powered by a first of its kind, patented mixing process called Permafusion, which fuses powerful, liquid active ingredients into a lipid-based carrier (petrolatum) without emulsifiers. Hexagen contains broad-spectrum, liquid antimicrobials with strong antiviral capabilities suspended in petrolatum. The product maintains a similar weight and feel to topical antibiotics, yet, unlike antibiotics, Hexagen has shown no resistance or allergic response in patients.
About Turn Therapeutics™:
Turn Therapeutics is a concept-to-approval research and development organization focused on novel, best in class products for infection control, skin disease, and wound care. The company's proprietary technologies are used every day by world-leading healthcare institutions to care for a variety of skin and wound conditions. For more information, visit www.turntherapeutics.com.
Forward-Looking Statements:
The statements contained herein may include prospects, statements of future expectations, and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance, or events may differ materially from those expressed or implied in such forward-looking statements.