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Hyloris Pharma expands cardiovascular pipeline by acquiring global rights of Milrinone capsule from the Baker Institute

Liège, Belgium
Monday, October 11, 2021, 16:00 Hrs  [IST]

Hyloris Pharmaceuticals SA, a specialty biopharma company, has acquired the global rights from the Baker Heart and Diabetes Institute (the Baker Institute), Melbourne, Australia, to CRD-102 (and related intellectual property), a novel, clinical-stage, extended-release Milrinone capsule in late-stage heart failure (HF) patients with an implanted left ventricular assist device (LVAD1) who have developed right HF.

CRD-102 is the second innovative product candidate that has been added to the portfolio this year, further delivering on Hyloris’ promise to expand the R&D pipeline with 4 new product candidates in 2021.

Milrinone is a positive inotrope, a group of heart failure drugs that strengthen the heart’s contractions so it can pump more blood with fewer heartbeats. Milrinone IV is currently approved for use as an intermittent or continuous infusion for treatment of up to 48 hours for acute decompensated heart failure. Longer term off-label use exceeding 48 hours of treatment duration has also been reported, requiring nursing support and limiting the patient’s quality of life by IV administration. Continuous IV use however exposes patients to an increased risk of common IV equipment complications, such as central line-associated bloodstream infections. Milrinone IV was approved in 1987 and in 2020 more than 12 million vials and infusion bags were sold, of which over 2 million in the US alone.

Prof Dr David Kaye, Heart Failure Specialist, Head of the Heart Failure Research Group at the Baker Institute and Director of the Department of Cardiology at the Alfred Hospital, Melbourne, Australia, commented: “Patients with end-stage HF, a serious, debilitating disease, experience extreme difficulties breathing, have a very poor quality of life and suffer from multiple, severe co-morbidities. The current standard of care is predominantly palliative and despite recent advantages with new heart failure therapies, the effectiveness of these is most pronounced in mild to moderate heart failure. CRD-102 has the potential to address the current unmet needs of late-stage LVAD patients by offering a patient-friendly and convenient oral treatment option as compared to repeated, continuous IV infusions, which is the current gold standard in many countries. Its efficacy and safety have been established in earlier phase 1 and phase 2 studies, and if these results can be repeated in pivotal studies, CRD-102 would have important potential in this underserved patient population.”

Stijn Van Rompay, chief executive officer of Hyloris, added: “We are very pleased to partner with the Baker Institute and believe that CRD-102 has the potential to dramatically change the lives of patients living with late-stage HF, more notably, patients with an LVAD who have developed right HF, a severe orphan HF indication. Earlier studies have demonstrated that treatment with CRD-102 resulted in improved quality of life and functional status of late-stage HF patients, and CRD-102 was well-tolerated with no increased incidences of arrhythmias being reported. CRD-102 perfectly fits within our portfolio of value-added cardiovascular products and our strategy for self-commercialisation in the U.S. We are now preparing the next stages of development and anticipate the start of the pivotal clinical study in LVAD patients with right HF towards end 2022 or early 2023.”

Under the terms of the agreement, Hyloris will be responsible for the further development, manufacturing, regulatory affairs, and commercialisation of CRD-102. In return, Hyloris will pay an upfront payment of $50,000 to the Baker Institute plus sales-based milestone payments and tiered, single to double digit net profit shares in markets where Hyloris intends to self-commercialise CRD-102. In markets where Hyloris intends to seek commercial partnerships, the Baker Institute is eligible to receive tiered, single to double digit net profit shares on net sub-license income.

CRD-102 is a novel, patented, extended-release Milrinone capsule that has been developed for patient-friendly, twice a day convenient oral dosing and provides a steady and predictable exposure of Milrinone. Hyloris will initially pursue a new, longer term use indication in patients with left ventricular assist devices (LVAD) who have developed right heart failure. Orphan drug status has been granted by the FDA in this latter indication and formulation patent claims have been issued in the US, Japan and China, and are pending in Europe. In a single dose PK study, patients treated with extended release (ER) Milrinone at a dose of 14mg twice daily, exhibited stable plasma levels within the therapeutic range. An open label safety and tolerability study of ER Milrinone 14mg twice daily in advanced (n=26) left heart failure patients with a history of recurrent hospitalisation generated >5 years patient exposure data and included a prolonged open-label compassionate use phase. ER Milrinone was well tolerated, with no effect on heart rate or blood pressure and was associated with improved functional activity as defined by NYHA Classification. ER Milrinone treatment was also associated with significant improvements in both quality of life (Minnesota Living with Heart Failure Score) and functional capacity (6-minute walk distance) with a trend towards improved renal function.

Heart failure is a severe and chronic condition in which the heart muscle is unable to pump enough blood to meet the body’s need for blood and oxygen. HF usually develops because the heart has been damaged by a heart attack, or because of other conditions such as cardiomyopathy, a disease of the heart muscle

Baker Heart and Diabetes Institute is an independent, internationally renowned medical research facility, with a history spanning 95 years. The Institute’s work extends from the laboratory to wide-scale community studies with a focus on the diagnosis, prevention and treatment of cardiovascular disease, diabetes, and their complications.

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimising existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors.

 

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