Arch Therapeutics (OTC:ARTH) yesterday announced the completion of the 1st-in-human study of its novel AC5 topical hemostatic device, touting that study primary objectives were met with no serious adverse events and safety outcomes similar between the AC5 and control groups.
The study aimed to evaluate the safety and performance of the AC5 in patients undergoing excision of skin lesions on the trunk or upper limbs, with a primary endpoint of safety throughout the surgical procedure through 30-days.
“As we had anticipated, these top-line data support that AC5 was safe and performed as expected in the patients enrolled in this study throughout the completion of the patient assessments post-treatment and as supported in the subsequent statistical analysis. These successful results mark a significant milestone in the development of AC5 and we are grateful to all of those involved in the process. We look forward to further advancing our self-assembling peptide technology platform for this and other applications, including through conducting additional studies,” CEO Terrence Norchi said in a press release.
The study also met its secondary endpoint, which was time to hemostasis, with a median time to hemostasis in the AC5 treatment group that was 41% faster than those in the control group, Arch Therapeutics reported.
“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. We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use,” study principal investigator Dr. Jack Kelly of Ireland’s Galway University Hospital said in prepared remarks.
Data from the 46-patient study reported an ASEPSIS wound score of 0 at days 7 and 30, indicating satisfactory healing per wound healing score criteria, the company said.
Arch Therapeutics said it expects to submit further study details and data to a journal for publication, and plans to use data from the trial for its CE Mark application for clearance in the European Union, which is expected to be filed by the end of the year. The company said it is planning its next clinical-regulatory steps for both the EU and the U.S.
“These results demonstrate significant improvement in efficacy without compromising patient safety. We believe that AC5 represents a unique technology that will provide both rapid and sustained hemostasis and important differentiable clinical benefits,” Norchi said in prepared remarks.