The University of Kentuciy Office of Technology Commercialization (OTC) has announced an important collaborative research project with US WorldMeds, one of the Commonwealth’s fastest growing pharma companies, based in Louisville. In 2017, the pair signed a letter of intent for a strategic collaboration pertaining to the research and development of US WorldMeds’ investigational product, lofexidine. If approved, lofexidine will be the first and only non-opioid medication indicated for the mitigation of symptoms associated with opioid withdrawal, one of the most powerful factors driving opioid dependence and addictive behaviors.

The collaboration brings together the range of expertise of both parties and leverages UK OTC’s deep knowledge of intellectual property management and commercialization services. The project idea first originated from a series of meetings between UK OTC’s director, Ian McClure, and US WorldMeds’ leadership to discuss potential collaborations that would harness UK’s research capabilities. Over the next several months, McClure and UK OTC’s commercialization manager, Alex Porter, met with the company’s Regulatory and Product Development teams to determine the research plan. The project’s main investigator is Patrick Marsac, UK College of Pharmacy, whose research focuses include:

• advanced analytics of materials and associated implications in drug discovery and development;
• application of engineering principles to biological systems; and
• thermodynamics and kinetics of phase changes of solid state pharmaceutical products.

The team has now completed the project planning and agreed on the scope. The plan proposes funding for two UK postdoctoral researchers and one UK graduate student. Also, as part of the scope, UK OTC will help monitor the research developments in terms of patentable discoveries to help guide the project to an IP-protectable result.

US WorldMeds is entering a vital regulatory stage with the U.S. Food and Drug Administration (FDA) regarding the possible approval of lofexidine. The FDA’s Psychopharmacologic Drugs Advisory Committee voted in March in favor of recommending approval of lofexidine for mitigating opioid withdrawal symptoms. The FDA will consider the Advisory Committee’s non-binding recommendation in its review of US WorldMeds’ new drug application for lofexidine and has set a Prescription Drug User Fee Act (PDUFA) action date for May of 2018.

McClure said, “The UK OTC/US WorldMeds research partnership could potentially play a critical role in providing a medical solution to people in Kentucky, and nationwide, experiencing the symptoms of opioid withdrawal, so they can successfully discontinue opioid use. I am pleased with this significant progress and hopeful it is the start of a productive, longer-term research relationship.”