Pfizer's innovative combination therapy of Clesacostat tromethamine and Ervogastat is showing promise in the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis, with projected annual revenues reaching $16 million by 2036 in the US market, according to GlobalData's Expiry Model.
Mechanism of Action and Therapeutic Approach
The oral combination therapy represents a novel approach to treating MASH, targeting two key metabolic pathways through inhibition of acetyl CoA-carboxylase (ACC) and diacylglycerol O-acyltransferase 2 (DGAT2). This dual-mechanism strategy positions the treatment as a new molecular entity in the therapeutic landscape for metabolic liver diseases.
Market Potential and Development Scope
Beyond its primary indication for MASH with liver fibrosis, the combination therapy has been investigated for metabolic dysfunction-associated steatotic liver disease (MASLD), suggesting potential broader applications in treating metabolic liver disorders. The development program reflects Pfizer's strategic focus on addressing significant unmet needs in metabolic diseases.
Financial Context and Company Performance
The development of Clesacostat/Ervogastat comes amid challenging financial times for Pfizer, which reported a 41.7% decrease in revenues to $58,496 million for fiscal year 2023. The company's operating performance shifted from a profit of $36,237 million in FY2022 to a loss of $929 million in FY2023, with net margins declining from 31.3% to 3.6%.
Risk Assessment and Valuation
Investment valuation for the combination therapy incorporates both revenue forecasts and estimated costs through risk-adjusted Net Present Value (rNPV) modeling. This conservative valuation approach accounts for clinical development risks and phase transition success rates, providing a more realistic assessment of the drug's potential market value.
