A discontinued heart disease drug may find new life as a treatment for sickle cell disease, with Roche handing off development of its antibody inclacumab to Global Blood Therapeutics.
GBT acquired the worldwide rights to the antibody for $2 million upfront, and signed on to pay about $125 million down the line, plus royalties, if inclacumab is approved to treat vaso-occlusive crises, the painful episodes caused when blood flow is obstructed by sickled red blood cells.
Roche previously completed clinical studies evaluating the safety and pharmacokinetics of inclacumab in more than 500 patients, but halted its development in coronary artery disease after a phase 2 trial.
“We have been working diligently to diversify our product pipeline through both internal research and external business development efforts and are excited to have entered into this agreement for inclacumab,” said Ted Love, M.D., president and CEO of GBT. “Inclacumab is an ideal complement to voxelotor, our lead investigational oral, once-daily therapy, in phase 3 clinical development for SCD.”
Inclacumab is a fully human monoclonal antibody antagonist that targets P-selectin, a cell adhesion protein found lining the walls of blood vessels and on the surface of activated platelets, helping them act as a coagulant in cell-cell interactions.
Voxelotor, meanwhile, is being studied as a therapy for the underlying mechanism of the disease, aiming to help hemoglobin retain more oxygen and keep red blood cells in their normal shape. The phase 3 trial is currently enrolling patients.
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According to GBT, the South San Francisco-based company has already begun transferring technology from the Big Pharma to a contract manufacturing organization and is planning to submit an IND application for inclacumab to the FDA in 2021 using Roche’s safety data.
Novartis is developing its own anti-P-selectin antibody, crizanlizumab, for the treatment of vaso-occlusive crises, which it picked up through a $665 million acquisition of Selexys Pharmaceuticals in November 2016.
In December of last year, Novartis described how a phase 2 post-hoc subgroup analysis found crizanlizumab delayed patients’ first on-treatment sickle cell pain crisis compared to placebo—doubling time to their first event, if not more, including in patients taking hydroxyurea.