This Charlottesville Company is Changing the Game in Wound Care

Written by Sarah Ellinwood for BioBuzz.

Imagine you’re working outside and accidentally cut your foot on a protruding stick you didn’t see. No big deal. You go inside and wash the wound, perhaps applying an antibiotic cream, and dress it in a bandage. Days and weeks, even months go by, however, and the wound just doesn’t want to seem to fully heal. Even the simplest of tasks such as walking becomes extremely painful, and just one wrong move reopens the wound.

For millions around the world, this is their daily reality. From diabetic ulcers to bedsores, from burns to cancer complications to infections, chronic wounds are complex and vastly underappreciated as a therapeutic space.

Molecular Biologicals, located in the blossoming biotech hub of Charlottesville, VA, is working to change the game in chronic wound care through its unique and proprietary keratin manufacturing platform.

You’ve likely heard of keratin before in some aspect – this protein is an essential part of our hair, skin, and nails, and is found as an ingredient in many haircare products. While keratin is touted for its ability to strengthen hair and tame frizz, make no mistake – the keratin that Molecular Biologicals is manufacturing is much different than what you’d find in the beauty aisle at your local drugstore.

The secret sauce is Molecular Biologicals’ Replicine™ bioactive keratin manufacturing process, which begins with sheering a sheep. Sheep’s wool is extremely rich in keratin, and the company’s proprietary process carefully extracts it from the wool in its fully intact form.

“The keratin products that many of us are familiar with are comprised of hydrolyzed, or broken-up, keratin proteins. While this type of keratin is useful for certain applications, it can’t drive wound healing,” said Kevin Combs, Molecular Biologicals CEO. “Our full-length keratin, on the other hand, is bioactive, meaning that it’s able to turn on different keratin-stimulated genes that help to jumpstart the production of cells that are crucial for wound healing, such as fibroblasts and keratinocytes.”

Wound healing happens in 4 stages. Chronic wounds occur when a wound gets stalled at Phase 2 (Inflammatory Phase). When this happens, individuals need to seek the care of a specialist to push the wound the rest of the way through Phase 3 (Proliferation Phase) and Phase 4 (Maturation Phase).

“The majority of products out there are focused on stimulating the earlier phases – Phase 1 and 2. On the contrary, Molecular Biologicals’ keratin products are unique in that they target the latter phases,” said Dr. Jonathan Johnson, founder and surgical director at Comprehensive Wound Care Services in Washington, D.C., and Molecular Biologicals advisor.

Just like you’d jump a car that’s stalled on the side of the road, Replicine™ bioactive keratin jumpstarts your body’s wound healing process to completely close the site of injury.

Currently Molecular Biologicals has three products in their arsenal – two gels (Keragel® and KeragelIT®) and an absorbable matrix (Keramatrix®)

Healing Begins Here

So far the effects of Molecular Biologicals’ products have been remarkable, showing clinical efficacy in a number of wound types including diabetic foot ulcers, pressure ulcers, skin graft donor sites, and first- and second-degree burns. Not only do the products heal better, but they also heal wounds faster.

“Wound care is very much a wait-and-see type of specialty, with wounds often having their own quirks. You try something, see if that works, and if it doesn’t take care of the issue you do something else,” said Dr. Jonathan Johnson. “We already have data showing that Keragel and Keramatrix are effective and heal more quickly compared to other treatments, meaning that instead of waiting and seeing we can more quickly evaluate which wound types are the best candidates for treatment.”

There is still more work to be done to elevate Keragel and Keramatrix products into the public spotlight, but already the products have had life-changing impacts to those who have used them.

“Being able to effectively treat a chronic wound goes way farther than just closing up an injury. It means our patients can be mobile again and enjoy the activities they enjoyed before. They become more social because they aren’t held back by the pain or the fear of reopening the wound,” said Dr. Jonathan Johnson.

And healing wounds quicker not only restores one’s quality of life, but it also relieves a heavy financial burden on the healthcare system. A recent study showed that chronic wounds affected nearly 15% of Medicare beneficiaries (8.2 million individuals), resulting in an estimated cost of about $28 billion when the wound was the primary diagnosis of a Medicare claim.

“Chronic wound healing is an arduous process and difficult to manage, especially as you get older. Being able to heal wounds quicker compared to the industry standards should have a notable impact on this cost,” said Kevin Combs.

Currently, Molecular Biologicals is initiating pilot nursing home studies to gather even more data on how Keragel performs on pressure ulcers. The study will compare standard of care to sharp debridement of bed ulcers to Keragel and evaluate parameters that include would healing rates and infection rates.

The trial is expected to start very soon, taking roughly 6 months to collect data and another 3 months to analyze the data. If all goes well, Molecular Biologicals anticipates being able to present data in December 2022.

Looking Ahead

A key focus for 2022 will be strategizing how to get the Keragel and Keramatrix products into more specialists’ hands, including podiatrists, dermatologists, and surgeons.

“There are a lot of wound healing products out there, but the clinical data so far show that we have something really remarkable,” said Kevin Combs. “Now, it’s all about getting the word out so that specialists around the nation can see the results for themselves. From there, we’re pinning down which places and services will be likely to see the biggest benefits from our products.”

In addition to pressure ulcers, Molecular Biologicals is in parallel evaluating how their keratin products can perform in the orphan disease market, starting with epidermolysis bullosa.

Individuals with this rare genetic condition are sometimes referred to as “Butterfly Children”, as their skin is as fragile and delicate as a butterfly’s wing. The slightest of touches can result in extremely painful blisters.

“This condition manifests as early as infancy. Think about how many times a day a new parent changes their baby’s diaper – something as simple as that can cause painful wounds. You can only begin to imagine how this disease impacts a child’s life as they grow up,” said Combs.

The team is working alongside Dr. Andrew South, an Associate Professor in the Department of Dermatology and Cutaneous Biology at Thomas Jefferson University, to evaluate if Replicine™ bioactive keratin can promote collagen-7-induced cell growth and proliferation in cell line models of epidermolysis bullosa.

The data from these experiments will be monumental in helping the Molecular Biologicals team better understand the mechanism of action at play for their products, which will help further pique the interest of practitioners.

“2022 is going to be a monumental year for us, and we’re excited for what lies ahead,” said Combs.