Rehovot-based HealOr’s proprietary treatment gets to the bottom of the problem of skin wounds that refuse to heal.
By Avigayil Kadesh
In the same way that "good" cholesterol and "bad" cholesterol must be in proper proportion for healthy arteries, "good" and "bad" forms of a protein called kinase must be balanced for wounded skin to repair itself. The Israeli company HealOr discovered that too much "bad" kinase is the reason chronic skin wounds – including foot ulcers afflicting about two million American diabetics – refuse to heal.
Its flagship product, a drug currently under testing in a Phase II/III clinical trial in the United States, Israel and India, activates the "good" kinase and inhibits the "bad" kinase to balance the chemical scales and spur healing of painful holes in the skin.
This is a revolutionary approach, says the nine-year-old company’s former chief medical officer and new CEO, Dr. Michael L. Sabolinski of Boston. "When a chronic wound happens and there isn’t enough good kinase to outweigh the bad, you have to go in and balance the seesaw, and that is the intent of HealOr," says Sabolinski.
"We’re focused on protein kinase because it affects skin cell growth factors, molecular pathways which trigger cells to migrate, proliferate and lay down a new matrix. The drug also has beneficial effects on the deepest layer, the hypodermis, and the immune system in the skin – all components which are important for the healing process of a wound, specifically a chronic wound in which almost all these processes are impaired."
HealOr’s product, made from a sequence of amino acids, is a topical liquid that patients can easily apply themselves.
Sabolinski, who previously managed the team that secured two FDA approvals for a living skin substitute made by Organogenesis, expects that related products in the HealOr pipeline will prove valuable in the fields of dermatology, ophthalmology and cancer oncology – systems that are also affected by epithelial cell health. "We focus on all layers of skin because neither provides the complete answer," he stresses. "All layers have to function together to heal a wound. This is something that wasn’t known until the last 10 years."
Several randomized, controlled trials now underway each follow patients for three to five months. "The patient uses the liquid daily for up to 14 weeks until the wound is healed," Sabolinski says. "The safety has been demonstrated and adverse effects are few."
Though he cannot predict when FDA regulatory approval will be finalized, his hope is that "you can have it on your shelf in two years – no longer than five." The product may be cleared for use in India before the United States.
Another advantage is that the product could easily be synthesized at labs anywhere, making it possible to commercialize it at a level appropriate to the large potential market. Some 30 million to 40 million people in the US alone suffer from diabetes, and chronic wounds affect others as well.
Sabolinski has more than 25 years of experience in wound-care research with a background in biochemistry and immunology. He has sponsored various clinical investigations of treatments for patients with acute and chronic wounds, and was instrumental in developing a partnership with Novartis Pharmaceuticals to market Organogenesis’ leading skin product globally. "The company’s board unanimously selected Sabolinski based on his impressive and proven track record in the wound-care field," said Dr. Pini Orbach, a member of HealOr’s board of directors.
Founded in 2002, the Rehovot-based HealOr is a privately owned specialty biopharmaceutical company. "Or" is the Hebrew word for "skin" and it is this – the body’s largest organ – that is the focus of its research. "Skin’s primary purpose is to be a barrier to bacteria and viruses," Sabolinski says. "If you have a hole in the skin, that opens the floodgates for disease, and it hurts too. You want to close the hole as fast as possible. That’s the bottom line."