Policy & Regulation
Turn Therapeutics Authorized to Start Human Trial for COVID-19 Therapeutic Candidate
21 January 2021 - - US-based biotechnology company Turn Therapeutics has initiated a two-part, four-arm, human safety and efficacy trial for its flagship product, Hexagen, to be used in the fight against COVID-19, the company said.

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, 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.

After receiving promising data demonstrating Hexagen's efficacy against human coronaviruses, Turn Therapeutics has worked with 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.

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.

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 by healthcare institutions to care for a variety of skin and wound conditions.