Turn Therapeutics Announces Human Trial Data for COVID-19 Early Intervention Candidate

August 25, 2021 at 14:27 PM EDT

Primary arm studied efficacy of 5 day intranasal use of petrolatum based Hexagen Antimicrobial for PCR confirmed COVID-19 positive patients
Secondary arm evaluated safety of 10 day intranasal use of Hexagen Antimicrobial as an adjunct to PPE for prevention of COVID-19 infection
75% of patients in treatment arm showed negative PCR results by day 3 (vs. 0% placebo), and 95% by day 5 (vs. 5% placebo)
Company plans to approach domestic and international regulatory and clinical authorities, while pursuing additional research

Turn Therapeutics, a biotechnology company specializing in advanced wound care and infection control, today announced the results of its Phase 2B, placebo controlled trial of Hexagen Antimicrobial Ointment in treating mild to moderate infected COVID-19 patients. This double-blinded study enrolled 80 people across three sites in Panama to evaluate safety and efficacy of Hexagen Antimicrobial as an early intervention against COVID-19. Specifically, the study investigated intranasal use of FDA-cleared Hexagen immediately post-positive PCR test as a means to reduce disease duration, as well as the safety of consistent intranasal use of Hexagen over 5 and 10 days. Efficacy results have confirmed in-vitro virucidal data, while safety results have confirmed in-vivo biocompatibility data for use on mucous membranes.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210825005725/en/

In the treatment arm of the study, hospitalized patients with confirmed COVID-19 infection were randomized to receive Hexagen or placebo. The course of treatment was designed to mimic that of intranasal Mupirocin for MRSA decolonization: Patients were administered .5 grams per nostril using a sterile swab, three times per day for five days. The study patients were tested via PCR swab three times on day one, then once per day for days 2-5. 95% of patients in the treatment arm achieved a negative PCR test within the 5 day period, with 75% testing negative by day 3. Only one patient in the placebo group achieved a negative test by the end of the 5 day period. No adverse events were reported for the duration of the study.

The study also included an open-label, observational arm to assess safety and efficacy of intranasal Hexagen as a prevention tool for healthcare workers against primary COVID-19 infection. While no adverse events were reported by either group in this arm, no statistically significant difference was reported among the active vs. placebo groups, as none of the study volunteers contracted COVID-19 during the assessment.

“The reduction of viral load early in COVID-19 is crucial to delaying or halting symptom progression,” said Dr. Neil Ghodadra, Chief Medical Officer for Turn Therapeutics. “We have tools for early intervention against many diseases, but a notable lack of options for early intervention against respiratory viruses such as COVID-19.”

“Hexagen’s effectiveness across a broad range of pathogens made it an ideal candidate to be repurposed in response to this global pandemic,” said Bradley Burnam, CEO of Turn Therapeutics. “COVID infections will continue to plague us for years to come. We are encouraged by these early results and excited at the prospect of bringing an early intervention tool for respiratory illnesses such as COVID-19 to clinicians worldwide.”

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.