Novel delivery system for tissue-regenerative molecules enables local, sustained release for greater efficacy

Alkem Laboratories Limited (Alkem) has signed a license agreement with Harvard University’s Office of Technology Development to develop and commercialize a novel technology to help treat diabetic neuropathy, foot ulcers, peripheral arterial disease, and other injuries caused by vascular disease. The technology is an injectable, biocompatible scaffold for the sustained release of tissue-regenerative molecules, developed by David Mooney at Harvard’s Wyss Institute for Biologically Inspired Engineering and John A. Paulson School of Engineering and Applied Sciences (SEAS). Mooney is also an Affiliate Faculty member at the Harvard Stem Cell Institute.

“This license agreement with Harvard enables us to harness an innovation with great clinical potential, identified and nurtured by the Wyss Institute, to bring novel treatments to market. It also serves as an example of Alkem’s commitment to fostering continued academic, clinical, and commercial collaborations to bring impactful medical technologies to patients,” said Sandeep Singh, the Managing Director of Alkem, an Indian multinational pharmaceutical company.

Alkem’s President and Chief Medical Officer, Akhilesh Sharma added, “This technology’s novel, regenerative medicine approach could help fill a therapy gap in the treatment of multiple causes of ischemic tissue injuries, with the potential to avoid several thousands of foot deformities and amputations and provide relief from other ischemic conditions.”

A new solution to enable regenerative medicine

Tissue-regenerative molecules help tissue regrowth after injury or chronic disease. Despite their therapeutic promise, these biologics have not yet been developed into FDA-approved treatments because they are very rapidly cleared from the body, which dramatically reduces their efficacy. Furthermore, because of the high doses required to overcome the clearance challenge, there has been concern that these treatments could cause toxicity when administered to patients orally or via injection.

To solve this problem, researchers led by Mooney developed a technique that encapsulates two of these molecules into a biocompatible scaffold that is injected under the skin at the site of ischemia and injury. The scaffold allows the molecules to be released in low doses steadily over time, enabling tissue regeneration.

Initiated as a collaboration between researchers at Harvard SEAS and the Wyss Institute, the technology advanced through development and de-risking at the Wyss Institute to demonstrate proof-of-concept. Preclinical studies in multiple animal models conducted at the Wyss Institute and University of Michigan demonstrated that blood perfusion recovered to 80–90%, muscle strength was restored to pre-injury levels, and nerve damage was reversed following injection with the treatment, with results persisting for several weeks to months.

“Scientists can point to many promising treatments for diseases and injuries that have never made it to the clinic, not because they don’t work, but because delivering them via a classic injection or pill wasn’t possible,” said Mooney. “I’m hopeful that our success in solving that problem for these tissue regenerative biomolecules will inspire others in academia and industry to revisit some of those ‘difficult’ drugs and make them available for more patients around the world.”

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This story is adapted from a news release written by Lindsay Brownell and originally published on the Wyss Institute website on February 10, 2022.