ROCKVILLE, Md.– Regio Biosciences (Regio), a Hibiscus BioVentures company, announced today it has entered into an exclusive license agreement with AstraZeneca to further develop REG-101, a novel therapeutic acting on reverse cholesterol transport (RCT). Regio expects to initiate a Phase 2a clinical program evaluating REG-101 in PAD during the second half of 2022.
Under the terms of the agreement, AstraZeneca will provide an exclusive license to Regio for further development of REG-101, previously known as MEDI5884, to address patients with high unmet medical needs, including PAD and cardiovascular disease. Regio will be solely responsible for all research, development, and commercial activities of REG-101. Initial financing for Regio’s development activities is being provided via investment by Hibiscus Capital Management (HCM Fund II) and Innoforce.
Plaque volume, a major issue in PAD, remains an urgent unmet need despite wide availability and use of LDL cholesterol-lowering agents. According to the CDC, more than 10 million people in the US currently suffer from PAD, causing significant morbidity, mortality, and functional limitation.
“The Regio team is thrilled to announce the signing of this license agreement with AstraZeneca to further develop REG-101,” said Chris Jeffers, Chairman of Regio Biosciences and CEO of Hibiscus BioTechnology. “We believe that REG-101 could complement the current standard of care as a patient-centric, once-monthly injection for peripheral artery disease.”
The Regio leadership team brings years of drug development experience, having worked directly on the REG-101 program. “Peripheral artery disease currently has few pharmaceutical options, and without appropriate treatment, symptoms of PAD can progress from pain while walking to gangrene and limb loss,” said Rakesh Dixit, Ph.D., President and CSO of Regio Biosciences. “We believe reducing the size of cholesterol-rich plaque within peripheral arteries using REG-101 has the potential to directly and positively address the underlying pathophysiology of PAD.”
Regio has partnered with CPC Clinical Research (CPC) and multiple clinical sites in the US to conduct a Phase 2a clinical trial in patients with peripheral artery disease. “Despite current standard of care therapies that address control of blood pressure, LDL cholesterol levels, and clotting risks, there are currently no available pharmacological treatments targeting reverse cholesterol transport to target the plaque that underlies the adverse effects negatively impacting millions of patients,” said Marc P. Bonaca, M.D., M.P.H., cardiologist, and vascular medicine specialist who serves as the Executive Director of CPC Clinical Research and CPC Community Health. “As a clinician, I believe a therapeutic that improves function, reduces the need for recurrent limb interventions as well as other adverse cardiovascular outcomes could provide meaningful improvements for patient quality of life.”
