Arch Therapeutics (OTCQB:ARTH) has multiple regulatory filings planned in the U.S. and Europe this year for its AC5 Topical Hemostatic Device as the biopharma company shifts to regulatory-stage footing ahead of commercialization.
“While we see a path to commercialization of AC5, we expect to remain a clinical-stage company as we develop subsequent products in our pipeline,” Dr. Terrence Norchi, president and CEO, says in an interview with BioTuesdays.
On the drawing board for 2017 is a filing for CE Mark approval in Europe, a 510(k) filing in mid-2017 for topical use in the U.S. and an investigational device exemption (IDE) filing in the U.S. to conduct a surgical trial for premarket approval (PMA) to use AC5 for internal use.
Dr. Norchi explains that AC5 is typically applied as a clear free flowing solution of self-assembling peptides that forms a scaffold or mesh gel of nanofibers within seconds of exposure to the ions naturally present in all bodily fluids, including blood, cerebrospinal fluid, and interstitial fluid.
Unlike many competitive products, he says AC5 conforms to irregular wound geometry, forming a barrier to achieve hemostasis, which then allows for normal healing while maintaining a clear field of vision directly into the wound area. Because it is not sticky or glue-like, it could be ideal for use in a range of open and closed procedures, he adds.
Arch’s preclinical pipeline includes several product applications with high medical need, including care of chronic cutaneous wounds and burns, prevention of surgical adhesions, sealing gastrointestinal anastomoses and ophthalmology. “We’ll advance the best product candidate where we see the most potential,” he suggests.
“Bleeding presents a significant clinical and economic burden. Any hole made in the body must be properly sealed and managed to allow for normal healing,” he adds.”
Bleeding also poses problems in surgical procedures and trauma, with loss of visual field and increased error risk, Dr. Norchi points out. Patients on anticoagulants and antiplatelet agents, also known as blood thinners, or those with co-morbidities, such as diabetes and renal disease, also are at increased bleeding risk.
“In our first clinical trial, AC5 has demonstrated it can establish a hemostatic barrier even in a patient taking blood thinners,” he contends.
Arch licensed the worldwide rights to the technology behind AC5 from MIT in Cambridge, MA. When adding patents covered by the license to its own patents and patent applications, Arch currently has more than 40 patients granted and pending to protect its intellectual property.
Dr. Norchi believes that existing products, such as gelatin, collagen, cellulose, polymers, thrombin and fibrin sealants, do not present ideal solutions to stop bleeding.
He says these products can be associated with a range of challenges, including unreliability, slow onset of action, handling restrictions, infections, negative inflammatory responses and healing problems. Some of the products can cost approximately $500 per application.
Many of the currently marketed products can take up to several minutes to stop bleeding, compared with often less than 30 seconds for AC5.
“What physicians want in a hemostatic barrier device is something that works quickly, easily, broadly and safely,” he points out, noting that this is the solution offered by AC5. “Data to date supports that our AC5 is biocompatible – or safe - and the amino acids that it is made of are themselves made synthetically, rather than derived from humans or other animals.”
Last August, Arch reported results from its first clinical trial in humans, which met its primary and secondary endpoints. The study was conducted in Ireland with 46 patients, 10 of whom were on blood thinners. Each patient had two freshly excised, or bleeding, skin lesions: one treated with AC5 and one control lesion treated with saline.
Specifically, the median time to hemostasis of wounds in the AC5 treatment group, including those on blood thinners was less than 30 seconds, which was a statistically significant 41% faster than for those in the control group. Notably, the control lesions on patients taking blood thinners took more than three times longer to stop bleeding.
Dr. Norchi says the company is working on a next generation kit that would contain prefilled syringes, compared with the current AC5 powder that must be mixed.
Arch’s plan is to file for CE Mark approval as soon as possible this year. A 510(k) filing for topical use of AC5 in the U.S. has been advanced to mid-2017 from the earlier plan of late-2017.
The company also expects to file an investigational device exemption with the FDA this year for an AC5 surgical trial in order to obtain premarket approval (PMA) of the device for internal use.
"Our anticipated 510(k) filing focusing on external skin applications should present a nearer-term opportunity for AC5, compared with our previous plan of filing a PMA for all uses in the U.S.,” Dr. Norchi says.
“We anticipate that the potential benefit from an earlier 510(k) filing is significant in terms of business opportunity and technology validation,” he adds. “Our intent to file a PMA for internal use after completing the necessary human clinical work also remains intact."
Industry analysts suggest that the $3-billion global hemostat market, which is dominated by a relatively small number of global firms, will double over the next seven years.
“We believe those firms will be increasingly attracted to, if not threatened by, Arch’s AC5 hemostat as it continues to develop,” Roth Capital Partners analyst, Michael Higgins, wrote in an initiation report last month. He believes that AC5 has the potential to “revolutionize the hemostat market.”
Mr. Higgins rates Arch shares at “buy” with a 12-month price target of $3. The stock closed at $0.63 on Friday.