Our Response to COVID-19
On February 8, 2021, Turn announced its first patient enrolled in a two-part, four-arm, multi-site human safety and efficacy trial for its FDA cleared flagship product, Hexagen®, to be repurposed as an intranasal viral load reduction agent for the treatment and prevention of COVID-19. The randomized, placebo-controlled trial is enrolling ~100 mild to moderate COVID-19 patients and 50 healthcare workers across three leading hospitals in Panama. The trials will assess the efficacy of a 5-day, three time per day nasal decolonization protocol in reducing viral load and symptom progression of mild to moderate COVID-19, as well as prevention of initial infection when used by healthcare workers as an adjunct to personal protective equipment. The healthcare arms are fully enrolled with the patient arm nearing full enrollment. Sites of the trials include internationally recognized Gorgas Memorial Institute of Health Studies which also serves as the central laboratory for sample analysis. The final dataset is expected to be available in Q2 2021; interim data reports have shown both high safety and efficacy. The principal investigator for the trial is Dr. Julio Sandoval, president of the ICU doctor association of Panama.
SARS-CoV-2 has been confirmed to target the nose. The nose is also the highest source of viral shedding. Vaccines have not been confirmed to prevent spread and people may still be a carrier and spreader even if vaccinated. The use of Hexagen® as an intranasal viral load reduction agent stands to fill key gaps in treatment and prevention. The Company plans to request emergency marketing authorizations from domestic and international health authorities pending results of the study.
Turn Therapeutics® Update On The Company’s Response To COVID-19
EMERGENCY USE AUTHORIZATION REQUEST FILED FOR THE USE OF HEXAGEN AS NASAL SHIELD TO AIRBORNE CONTAMINANTS INCLUDING SARS-CoV-2
Our original, trusted, multi-time FDA cleared formula has recently received promising data supporting its effectiveness as a nasal barrier against such airborne contaminants as human coronavirus. Given this data and our many years of safety and efficacy in human use, Turn Therapeutics® has filed for Emergency Use Authorization (EUA) as a medical countermeasure in the fight against COVID-19.
Our Response to COVID-19
On February 8, 2021, Turn announced its first patient enrolled in a two-part, four-arm, multi-site human safety and efficacy trial for its FDA cleared flagship product, Hexagen®, to be repurposed as an intranasal viral load reduction agent for the treatment and prevention of COVID-19. The randomized, placebo-controlled trial is enrolling ~100 mild to moderate COVID-19 patients and 50 healthcare workers across three leading hospitals in Panama. The trials will assess the efficacy of a 5-day, three time per day nasal decolonization protocol in reducing viral load and symptom progression of mild to moderate COVID-19, as well as prevention of initial infection when used by healthcare workers as an adjunct to personal protective equipment. The healthcare arms are fully enrolled with the patient arm nearing full enrollment. Sites of the trials include internationally recognized Gorgas Memorial Institute of Health Studies which also serves as the central laboratory for sample analysis. The final dataset is expected to be available in Q2 2021; interim data reports have shown both high safety and efficacy. The principal investigator for the trial is Dr. Julio Sandoval, president of the ICU doctor association of Panama.
SARS-CoV-2 has been confirmed to target the nose. The nose is also the highest source of viral shedding. Vaccines have not been confirmed to prevent spread and people may still be a carrier and spreader even if vaccinated. The use of Hexagen® as an intranasal viral load reduction agent stands to fill key gaps in treatment and prevention. The Company plans to request emergency marketing authorizations from domestic and international health authorities pending results of the study.
Turn Therapeutics® has proposed to FDA that petrolatum-based Hexagen® be applied to the nares as extended-wear, antimicrobial/antiviral PPE to reduce uptake of airborne contaminants such as SARS-CoV-2 viral pathogens. Recent research has identified evidence that cells in the nose (goblet secretory cells), lungs (type II pneumocytes), and intestines (absorptive enterocytes) may be particularly susceptible to Covid-19 infection based on their cell-surface receptors, which further supports the use of Hexagen® as a nasal barrier for non-infected individuals. New research has also corroborated the theory that Covid-19 likely enters the body through the nose, as nasal epithelial cells have the highest concentration of the proteins that Covid-19 targets of any surface in the airway.
Hexagen® vs. Coronavirus
Testing Results
In laboratory testing, the Hexagen® formula showed a dramatic ability to eliminate over 98% of Human Coronavirus within just 2 hours without harming healthy cells. Notably, over 80% of this elimination took place in the first 10 minutes. Early human trial data readouts show promise as a therapeutic agent.
From the Founder
The Story of Hexagen
Consumers have been stuck with the same topical antibiotics since the 1950’s and 60’s. Brands like Neosporin® and Polysporin® became household names with no real medical clearance, and homeopathic management
FAQ
Hexagen and its formulaic twins (CurX® and AtopX®), were initially created and marketed as a non-antibiotic, equally gentle alternative to first aid antibiotics such as Neosporin and Polysporin. The formula’s active ingredient, Benzalkonium Chloride (BZK), is commonly found in other antiseptics such as Bactine and alcohol-free hand sanitizers. The difference lies in Turn Therapeutics’ Permafusion Technology, which permits Hexagen to administer a strong dose of permanently suspended, liquid BZK over an extended period of time, while also being non-cytotoxic, non-sensitizing, and non-irritating to human tissue and mucous membranes.
The use of Hexagen has evolved over time. It was originally produced to be a competitor to Neosporin. In this labeling, it was named CurX and marketed for over the counter use. Over time, wound experts across the country increasingly remarked that CurX had potential beyond the first aid realm. In fact, studies were showing that it was serving as a much-needed replacement for antiquated, standard of care chronic wound products for such conditions as diabetic ulcers, burns, trauma wounds, and more.
As a result, Turn filed for 510(K) clearance to compete in this market with the proper labeling. Upon receiving clearance from the FDA in 2016, Turn withdrew CurX from the OTC market and relaunched it as Hexagen, then made it available to medical professionals for Rx only, acute and chronic wound care.
Hexagen has been certified by FDA as non-cytotoxic, non-sensitizing, and non-irritating to human tissue. Additional, ISO 10993 testing has confirmed it safe on mucous membranes. We recommend anyone with a history of allergies to the ingredients not use it, but we have not received reports of any adverse reactions.
Hexagen was tested using an ASTM 1052E suspension time kill protocol against human coronavirus in an FDA licensed, BSL2 certified laboratory. The full results of the tests can be found here. Hexagen was successful in killing over 80% of coronavirus present within 10 minutes, with a vertical kill curve suggesting continued and increasing kill over time. Given the petrolatum base, Hexagen can be left in the nose/on the tissue for multiple hours, although we recommend 2-3 applications per day to ensure consistent and thorough decolonization. In its chronic wound labeling, the FDA cleared Hexagen to be left on delicate, breached tissue for 72 hours between dressing changes.
Hexagen has been cleared for chronic wound care by the FDA. It’s prior offering, CurX, was offered as an over the counter antiseptic ointment. We have new data that supports Hexagen may be effective as a nasal decolonization ointment against human coronavirus, which is currently being reviewed by the FDA for an Emergency Use Authorization.
Hexagen is not meant to serve as a replacement for masks or any other PPE. You should always follow current CDC guidelines on how best to protect yourself.
Hexagen is available for prescription use for acute and chronic wound treatment, and is the subject of an EUA under review with the FDA for its use as a nasal decolonizing ointment with activity against human coronavirus. Turn is currently working to scale up production of Hexagen to make the product more widely available in the event EUA is granted.
Media Inquiries
If you have media requests, please fill out the quick contact form. You can read more about Hexagen® in the press through these links:
COVID-19 Resources
WHO (World Health Organization)
CDC (Center for Disease Control and Prevention)
