The potential combination therapy comprises diacylglycerol O-acyltransferase 2 (DGAT2) inhibitor ervogastat and an acetyl-CoA carboxylase (ACC) inhibitor clesacostat
Pfizer World Headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia)
Pfizer has received the US Food and Drug Administration (FDA) Fast Track designation for its experimental combination therapy to treat non-alcoholic steatohepatitis (NASH).
The potential combination therapy comprises diacylglycerol O-acyltransferase 2 (DGAT2) inhibitor ervogastat and an acetyl-CoA carboxylase (ACC) inhibitor clesacostat.
DGAT2 and ACC are two important enzymes that regulate lipid metabolism.
The drug combination works by inhibiting ACC and DGAT2, where the two enzymes play an important role in regulating lipid metabolism.
The US drugmaker believes that its investigational combination therapy has the potential to deliver direct improvements in inflammation and fibrosis.
Pfizer internal medicine and hospital senior vice president and chief development officer James Rusnak said: “Receiving Fast Track designation from the FDA reinforces Pfizer’s belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies.
“We are proud to be advancing this investigational combination as part of our goal to develop innovative medicines to address some of the world’s most widespread health challenges that affect millions of people—including diseases like NASH.”
The US FDA grants Fast Track designation to support the development and review of new drugs and vaccines to treat or prevent serious conditions and address the unmet medical need.
The current FDA designation is based on the results of Pfizer’s nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat.
In the study, treatment with the drug combination reduced liver fat with a favourable safety and tolerability profile.
The US drugmaker is currently evaluating ervogastat/clesacostat in an ongoing Phase 2 trial to assess its impact on NASH or liver fibrosis which is expected to be completed in 2024.
The results of the study, which also includes arms investigating ervogastat as monotherapy, will inform a potential Phase 3 development programme, said Pfizer.
Earlier this month, Pfizer signed a definitive agreement to acquire clinical-stage biopharmaceutical company Biohaven Pharmaceuticals for $11.6bn.
Biohaven is engaged in producing NURTEC ODT (rimegepant), a dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults.