The AC5 Topical Hemostatic Device showed good safety and faster time to hemostasis in a 46-patient study.
It's so far, so good for the AC5 Topical Hemostatic Device.
Recently released topline data from a small study has shown the solution is safe and achieved hemostasis of skin wounds 41% faster than standard treatment. AC5-developer Arch Therapeutics is planning to use these study results in a CE Mark application for the device.
The AC5 device doesn't look like your typical device. It is a slightly viscous liquid that Terrence Norchi, MD, president and CEO of Arch Therapeutics, compares to the consistency of alcohol-based hand sanitizer. Still, the product is expected to be regulated as a device because of its unique technology. Norchi told MD+DI that the topical AC5 consists of self-assembling peptides that interact with the highly charged environment of a wound to build itself into a physical barrier over the wound.
AC5 is being regulated as a device in Europe and is likely to be viewed similarly by FDA. Norchi pointed out, "It's that self-assembly that has allowed us to go down the pathway of being a medical device rather than a traditional drug . . . A device is something that requires for its primary effect neither metabolic activity nor chemical activity of the body. The fact that [AC5] will self-assemble out of body, without being metabolized, that it will do so in your pasta sauce, is very supportive of this being a device."
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The 46-patient study was the first to test AC5 in humans. Each patient in the study had at least two skin lesions that were removed under local anesthetic. Each patient received both treatments--one on each wound--wounds were randomized to treatment with AC5 or standard therapy with a sham application of saline with a syringe. The primary endpoint assessed safety through 30 days post-procedure. Neither the control group or AC5 group had any serious adverse events and the two groups had similar safety results, according to a company press release. Importantly, a secondary endpoint evaluating wound healing found no evidence of AC5 having any detrimental impact on healing.
Time to hemostasis was measured as a secondary endpoint. Wounds treated with AC5 had a statistically significant faster median time to hemostasis--41% faster than wounds in the control group (p<0.001). "We've seen ranges from 10-15 seconds to half a minute to certainly under a minute. We're not looking at times north of a minute," Norchi said.
Study principal investigator Jack Kelly, MD, a plastic, reconstructive, and aesthetic surgeon and professor of surgery at Galway University Hospital in Galway, Ireland, said in the release, "These study results indicate significant potential for AC5 in the treatment of bleeding skin wounds. The safety and efficacy outcomes for AC5 in this study were impressive and reassuring. While possessing a safety profile at least as good as that of the control group, AC5 was associated with a clinically significant improvement in time to hemostasis."
The study excluded patients with major underlying conditions like active malignancies, pregnancy, or organ failure. But, of the 46 patients studied, 10 were on one antiplatelet product. Data from that subset of patients will be analyzed to determine whether they experience a similar desired hemostatic effect with AC5, Norchi said. "Those patients tend to bleed more. Our underlying mechanism of action being self-assembly should be relatively agnostic to somebody's coagulation cascade and bleeding tendencies."
Kelly noted AC5's ease of use. "We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use," he said in the release.
Norchi echoed this sentiment. He pointed out that AC5 doesn't require cold storage and is simple to prepare, with the current formulation just requiring doctors to mix the powder with water and apply it using a syringe.
"I recall doing some animal surgery once with a human surgeon." Norchi said. "She looked at me after using [AC5] for the very first time and said, 'This stuff is beautiful.' I think to use it is to really appreciate it."
Arch Therapeutics anticipates that this study data will be published in a peer-reviewed journal and plans to use the data as part of its CE Mark application. That regulatory submission is slated at earliest by the end of 2016. As for plans in the United States, Norchi said the company tentatively intends to file an FDA submission in 2017, but cautioned that "submission is a coordination of a number of activities beyond just the clinical trial."
This study is just the beginning of the trials Arch Therapeutics plans to conduct. The company is focused on building a broad set of products, Norchi said, including an internal hemostatic device for surgical procedures, products for chronic cutaneous ulcers, prevention of surgical adhesions, and various form factors of its technology.
"If a surgeon or health care provider sees bleeding, he or she can pick our product off the shelf. That's the goal," Norchi said.
[Images courtesy of ARCH THERAPEUTICS]