AstraZeneca acquires oral PCSK9 inhibitors from Dogma Therapeutics

Pharma giant AstraZeneca has signed a deal to acquire a preclinical oral PCSK9 inhibitor asset from Dogma Therapeutics, a portfolio company of Viva Biotech.

The financial terms of the deal were not disclosed.

AstraZeneca intends to take the PCSK9 inhibitor program into clinical trials in 2021 for dyslipidemia and also familial hypercholesterolemia.

People having dyslipidemia, have an abnormal quantity of low-density lipoprotein (LDL cholesterol) or bad cholesterol and other lipids in their blood.

The other condition – familial hypercholesterolemia is a genetical disorder that causes high cholesterol.

PCSK9 is a protein that is known for regulating the levels of LDL cholesterol in the blood and its increased activity has been associated with high LDL cholesterol.

According to AstraZeneca, the PCSK9 inhibitors it has acquired from Dogma Therapeutics are small molecules that directly fix to a novel part of the PCSK9 protein.

AstraZeneca acquires oral PCSK9 inhibitors from Dogma Therapeutics. Photo courtesy of AstraZeneca.

The PCSK9 inhibitors of Dogma Therapeutics were successful in preclinical models where they showed their ability to block the activity of the protein, which helped in reducing the levels of LDL cholesterol.

AstraZeneca’s interest in acquiring the small molecules is due to the fact that no other oral inhibitors of PCSK9 are available in the market and are not even in clinical development.

Mene Pangalos – Executive Vice President of AstraZeneca BioPharmaceuticals R&D 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 stands to be paid an undisclosed upfront consideration followed by milestone-based payments pertaining to achieving certain global regulatory and commercial goals.

Brian Hubbard – CEO of Dogma Therapeutics said: “We have built a robust data package that highlights the cholesterol-lowering and safety potential of our oral PCSK9 program.

“This agreement with AstraZeneca meets our strategic goal to accelerate access to patients unable to meet target LDL-C.  I would like to especially thank our scientific partners – Charles River Laboratories, Viva Biotech, Anji Pharmaceuticals, and our CRO partners – for their commitment to this project and their world-class problem solving.”