The pharma major plans to advance the PCSK9 inhibitor programme into clinical development for dyslipidaemia and familial hypercholesterolemia in 2021.
Dyslipidaemia is a condition in which there is abnormal amount of lipids like low-density lipoprotein (LDL cholesterol) or bad cholesterol present in the blood. On the other hand, familial hypercholesterolemia is a common genetic condition that leads to high cholesterol.
According to AstraZeneca, PCSK9 is a protein that controls the LDL cholesterol levels in the blood. Heightened activity of the protein is related to high LDL cholesterol, said the company.
The acquired PCSK9 inhibitors by AstraZeneca are small molecules which directly bind to a novel part of the protein. In preclinical models, the inhibitors have shown to prevent the protein’s activity and had resulted in lower LDL cholesterol.
Presently, there are no oral inhibitors of the protein that are either available to patients or in clinical development, said the pharma major.
AstraZeneca biopharmaceuticals research and development executive vice president Mene Pangalos said: “Raised LDL cholesterol is a key risk factor for cardiovascular disease and is estimated to cause 2.6 million deaths worldwide every year. Whilst PCSK9 is a well validated target for lowering LDL cholesterol it has been a hugely challenging target to inhibit with small molecules.
“This agreement with Dogma Therapeutics offers us the opportunity to develop the first small molecule, orally bioavailable PCSK9 inhibitor, for patients at risk of cardiovascular disease.”
Dogma Therapeutics, which is a portfolio company of Viva Biotech, will get an undisclosed upfront amount for the sale. Besides, the company will be eligible to downstream payments that will be based on meeting of global regulatory and commercial milestones.
Viva Biotech chief scientific officer Zhixiong Ye said: “Viva Biotech has begun to incubate and invest in Dogma Therapeutics since 2017. It was an exceptionally rewarding experience for our team to have a close partnership with Dogma during the exciting discovery phase.
“An orally-bioavailable small molecule PCSK9 inhibitor will greatly impact the unmet medical needs of cardiovascular patients.”