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Skin Regeneration Inspired by Superhealer Mice

BIOTECH: Eluciderm Wins Wound Healing Award, Aims for 2025 Clinical Trials

SAN DIEGO – When the FDA issued a request in 2022 for drug companies to innovate treatments for chronic wounds, San Diego-based Eluciderm, Inc. was one of the few companies already working on a small molecule solution – one that was inspired by superhealer mice.

This year, the company’s novel approach using Wnt inhibitors – a class of small protein drugs that block specific signals from reaching certain cells – was recognized by the Wound Healing Society with the Wound Shark 2024 Innovation Award.

Daniel Holsworth, Ph.D.
CEO
Eluciderm, Inc.

“It is very gratifying to be recognized as an up-and-coming leader in the field of regenerative medicine,” said Eluciderm CEO Daniel Holsworth, Ph.D. “We believe the paradigm shift we bring to wound healing with our novel technology and pipeline of small-molecule therapeutics will make the difference between simply managing patients’ wounds and truly healing them.”

Of Mice and Skin

Eluciderm was founded in 2018 by Holsworth and other researchers exploring uses for Wnt and Wnt inhibitors. Holsworth’s interest in inhibiting Wnt pathways began in 2008, researching its potential in treating colorectal cancer at Norway-based Odin Therapeutics. The approach had limited success, he said, because the intestine offered “too narrow of a therapeutic index.”

Cells in the intestine need to keep replicating, so inhibiting the pathway too much results in an unhealthy intestine from toxicity, and inhibiting too little allows the cancer to continue to grow. “It’s really tough to suppress replication but not shut it off,” he explained.

Although inhibiting Wnt did not pan out in colorectal cancer, a research paper out of Vanderbilt University by Sarika Saraswati, Ph.D. on superhealer mice would prove to be the inspiration for Holsworth’s pivot to focusing on skin and healing wounds.

Sarika Saraswati, Ph.D.
Chief Scientific Officer
Eluciderm, Inc.

Saraswati – who now serves at Eluciderm’s chief scientific officer – studied superhealer mice to show how Wnt inhibitors regenerate tissue. Superhealer mice were first discovered in the early 1980s after a group of cancer researchers manipulated mice to be immunodeficient so that when they tested oncology drugs on them, the researchers would “know it’s the drug doing the action of killing the tumor, not the mice’s innate immune system,” Holsworth said.

Research mice are tagged by punching holes in their ears and in normal mice, the holes remain. However, the immunodeficient mice’s ears would fully heal after a few weeks. In 2013, Saraswati’s Vanderbilt team studied stem cells of superhealer mice and discovered that overexpressed inhibitory proteins that suppressed Wnt pathways allowed the mice to regenerate their ear tissue. Those proteins became the basis for Eluciderm’s lead candidate ELU42, which mimics the capabilities of superhealer mice in people.

“Our 10 years of laboratory studies mimicking the functionality of the Wnt pathway of superhealer mice revealed the intriguing possibility of regenerating healthy tissue by modulating the Wnt pathway,” Saraswati said. “It is both humbling and exciting to think that our basic biological research has inspired the development of a medicine that could help people.”

Large Unmet Need

Since 2018, Eluciderm has raised $7 million to date, with $2 million of that from a seed investor, the CEO said. The payoff for the company’s founders and investors could be quite substantial.

According to 2014 Medicare data, the market for treating open wounds – the area where FDA sees the greatest need – is around $100 billion. And that is not the only market that Eluciderm’s technology could address.

John Delgado, MD.
Chief Medical Officer
Eluciderm, Inc.

“Our market is skin – skin injury, skin inflammation, skin cancer, skin dermatitis. It’s all the things that go wrong with skin,” said Eluciderm Chief Medical Officer John Delgado, MD.

In addition to developing ELU42, the company is also developing other molecules to address a variety of needs in dermatology, including all invasive surgery settings; regenerating elastic cartilage for ENT procedures; and improving plastic surgery.

“We’re getting basically all dermatologic procedures and at the same time inflammation,” Delgado said, adding that Eluciderm’s approach offers more rapid and more functional healing with “brand-new skin” that has less scarring and has more elasticity. “No one’s been able to do this. It’s healing like a starfish.”

Eluciderm is aiming to file an IND with the FDA for ELU42 by the end of the year, Holsworth said, and plans to start clinical trials Q1 2025.

Eluciderm, Inc.
FOUNDED: 2018
CEO: Daniel Holsworth, Ph.D.
HEADQUARTERS: San Diego, Torrey Mesa
BUSINESS: regenerative medicine-focused pharmaceutical company
FUNDING: $7 million (seed)
TEAM MEMBERS: 17
WEBSITE: www.eluciderm.com
NOTABLE: Eluciderm is the winner of the Wound Shark 2024 Innovation Award.

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