Study completion and submission of 510(k) notification expected in Calendar Q3 2018
FRAMINGHAM, Mass., June 15, 2018 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB:ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, announced today that it has completed enrollment for its human skin sensitization study and that applications of the Company’s AC5™ Topical Gel are underway for all subjects. The study is anticipated to conclude during the third quarter.
Terrence W. Norchi, MD, President and CEO of Arch, said, "This study is an important component of our plans to address the request by the Food and Drug Administration (FDA or “the Agency”). The Agency had requested further evidence beyond that which was previously supplied to support that AC5 does not cause sensitization in humans. We are pleased that enrollment was completed within the expected timeframe and that the study volunteers have entered the repeat dosing phase.”
The study protocol was designed with input from Arch’s expert advisors and the Agency in order to support the Company’s 510(k) submission for its AC5™ Topical Gel. As previously announced, the study is expected to cost approximately $100,000 and take about three months. We anticipate filing a 510(k) notification by the end of the third quarter of calendar 2018.
Dr. Norchi added, “We expect the future anticipated 510(k) notification to contain both the information previously reviewed by the FDA, including the favorable results from a required animal test for sensitization, and the additional data from this human sensitization study. We believe that there are no other material items to address with the Agency.”
As the study is conducted, Arch remains focused on manufacturing scale-up, clinical regulatory strategy, developing commercial partnerships, enhancing its intellectual property portfolio and expanding its pipeline of products.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.
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Source: Arch Therapeutics, Inc.