Alucent Biomedical Inc., which is developing a restorative therapy for peripheral artery disease (PAD), completed a $35 million series B financing led by a multinational strategic investor. The funds will be used to complete clinical studies of the Alucent Natural Vascular Scaffolding (AlucentNVS) vessel restoration system with photoactivated linking, the company’s first product.

Also participating in the round were Fresenius Medical Care Ventures and Avera Research Institute, an arm of Avera Health. With the series B funds, Alucent has raised roughly $60 million to date.

“The series B funding will allow us to continue to explore the potential of AlucentNVS to improve long-term clinical outcomes and enhanced quality of life for those with vascular disease,” said Myles Greenberg, Alucent’s president and CEO.

First-in-human trial

The Salt Lake City-based startup began enrolling patients in its ACTIVATE I first-in-human trial in May. The phase I study is evaluating the safety and efficacy of the AlucentNVS technology in patients with PAD of the lower extremities. The first patients were enrolled at Ballad Health Wellmont Hospital Valley Medical Center in Kingsport, Tenn. Up to 15 patients will be enrolled across five clinical sites.

The ACTIVATE I trial is about one-third enrolled and expected to complete by the end of the year, Greenberg told BioWorld, adding that the COVID-19 pandemic has slowed the pace of enrollment.

The prospective, nonrandomized, multicenter, open-label study will assess the safety, pharmacokinetics and preliminary efficacy in applying AlucentNVS therapy to de novo lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) during percutaneous transluminal angioplasty in patients with life-limiting pain due to obstructive SFA and PPA atherosclerosis.

The primary endpoints is freedom from all-cause mortality, target limb major amputation and target lesion revascularization and AlucentNVS drug plasma concentrations.

IDE study planned for mid-2021

Alucent is also in the process of finalizing the protocol for a larger IDE clinical trial to support a U.S. FDA submission for the AlucentNVS system. The study is slated to start in mid-2021 and will include up to 100 subjects at up to 15 U.S. medical centers.

That study will also focus on lower-extremity PAD, with patients followed for 12 months.

“The best projections we currently have are that we are approximately five years from filing for [FDA] regulatory approval,” Greenberg said.

Efforts are also underway to secure the CE mark, “although the EU’s new MDR process has slowed this for us and many other companies,” he added.

How it works

Integrated light fiber illuminated. Credit: Alucent Biomedical Inc.

AlucentNVS, which combines standard angioplasty with photoactivated linking of structural proteins in the vessel wall, is intended to treat PAD in the lower extremities, a debilitating and painful disorder that afflicts more than 200 million people globally.

While standard treatment for PAD includes balloon angioplasty, drug-coated stents and bioabsorbable stents, among other options, AlucentNVS utilizes a light-activated drug delivered to the area. No temporary or permanent device is implanted, and the drug is intended to eliminate the need for retreatment by strengthening the area.

Alucent’s novel drug is delivered via a specialized vascular delivery catheter. In concert with adding the drug to the affected area, an angioplasty balloon is inflated in the vessel, enlarging it as in traditional methods. As that is being done, a specialized light fiber inside the balloon shines the appropriate wavelength of blue light onto the area to activate the drug.

The system’s drug action then links collagen and elastin in the affected vessel, thus strengthening the vessel wall.

‘Revolutionary technology’

“Alucent Biomedical is a welcome addition to our portfolio,” said Al Wiegman, head of Fresenius Medical Care Ventures. “The company’s first-rate management team is developing a revolutionary technology that has the potential to dramatically improve treatment for the millions of people who suffer from PAD. We believe AlucentNVS stands to completely reshape how physicians think about treating vascular conditions.”

The AlucentNVS technology was developed under Avera Health, a five-state, nonprofit health system based in Sioux Falls, S.D. Ron Utecht, a former chemistry professor at South Dakota University, led the therapy’s development at Avera, working under the Alumend organization, a technology development subsidiary of Avera Health. Avera invested more than $20 million in the research.

Once the R&D was completed, Avera spun out Alucent in 2017 to handle the clinical development phase and commercialization.

While the current focus in on lower-extremity PAD, Greenberg said there’s no reason why AlucentNVS wouldn’t work in many other vascular beds. The company currently is working on a second vascular indication.

“We have designed the technology to durably open blood vessels without the complications of implants left behind in the vessels,” Greenberg said. “If we are successful in demonstrating the durable effect in patients, AlucentNVS could disrupt a number of other, older approaches to opening vessels, including balloon angioplasty and stenting.”