After nearly a year of correspondence with the U.S. Food and Drug Administration, Turn Therapeutics in Calabasas finally has its first human safety and efficacy trial lined up for a COVID-19 therapy.The company looks to use its flagship product, Hexagen, as a nasal treatment for COVID patients with mild to moderate symptoms.Hexagen is already FDA approved to treat open wounds and control infection, according to Chief Executive Bradley Burnam. Its Vaseline-like consistency is 95-percent petrolatum.“We learned at the end of last year, beginning of this year, that a number of hospital workers, hospitals carrying our product, were putting this product in their nose as added protection from COVID,” said Burnam. “It gave us an idea of how it can be repurposed once we had clinical data to support it.”Nurses were using Hexagen in this way of their own volition, Turn staff said.Added Burnam: “We ran some lab data against human coronaviruses and it turns out that the product itself, which has been proven safe for use on mucous membranes, is actually quite effective at eliminating them. The nose is where COVID targets. We talk about the ACE2 receptors … the highest concentration of them is in the nose, so COVID targets and incubates in there. There’s a reason we swab the nose to see if patients are positive.”Approximately 100 COVID patients in Panama, along with 50 health care workers, are participating in the study at four hospitals. The Gorgas Memorial Institute of Health Studies in Panama City will serve as the central laboratory for sample analysis.“COVID trials are incredibly difficult, especially outside of large pharmaceutical companies,” said Zach Keating, communications representative for Turn. “They cost upwards of tens of millions of dollars. We weren’t prepared to invest that much, and we were definitely at the back of the line in terms of the FDA, so we got creative.
“We used connections and were able to find a partner down in Panama … really fine research institutions that are able to approve, enroll and collect at a faster rate than in the U.S.,” continued Keating.“Products like Remdesivir and hydroxychloroquine … they did their trials in China,” said Burnam. “We’re actually not outside of the norm to go gather our data across borders. We can move faster, and there’s a pandemic happening right now so fast is important.”Participants received a five-day, three-times-per-day nasal ointment to reduce viral load and symptom progression. Data from the trial is expected in the next month-and-a-half, and the company plans to submit materials to the FDA in March. After FDA approval, Turn will start marketing the product as a COVID treatment.That’s the next step for the small biotech company — taking Hexagen to market, for COVID use, on its own.“This would be our first foray into that, doing it all ourselves without partners,” Burnam said. Prior to the current endeavor, Turn leveraged larger companies for regulatory work and used contract manufacturers while its small four-person, full-time staff helped choreograph and manage partnerships.Turn describes itself as “having transitioned from startup to stay-up.” They’ve raised more than $10 million mostly from angel investors and family practice offices across the U.S., but they’re “on the trail,”so to speak, for “growth capital to scale for this worldwide launch,” Burnam said.