Gilead plans $4.3 billion deal to advance liver portfolio

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Gilead Sciences has agreed to acquire CymaBay Therapeutics for a total equity value of $4.3 billion. Gilead confirmed that CymaBay’s lead product candidate seladelpar has a best-in-disease profile for second-line primary biliary cholangitis (PBC). This is based on data from the Phase III RESPONSE trial.

The company shared that seladelpar is an oral, selective peroxisomeproliferator-activated receptor delta (PPARδ) agonist. Clinical studies have demonstrated its potential in regulating genes involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage, and transport.

In the pivotal Phase III RESPONSE trial, seladelpar achieved:

• Statistical significance for biochemical response – 61.7 percent for patients on seladelpar versus 20.0 percent for placebo
• Normalisation of alkaline phosphatase at 12 months – 25.0 percent for patients on seladelpar versus 0.0 percent for placebo
• Statistically significant improvement in pruritus at six months in individuals with moderate-to-severe itch that was sustained through 12 months.

In gaining rights to seladelpar, Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences stated that the company has “the potential to address a significant unmet need for people living with primary biliary cholangitis (PBC) and expand on our existing broad range of transformational therapies.”

The transaction is expected to close during the first quarter of 2024, subject to certain customary closing conditions.

Seladelpar’s potential in primary biliary cholangitis (PBC)

According to Gilead, this rare, chronic, cholestatic liver disease mainly affects women. The disorder impairs liver function, which also results in a reduced quality of life. The most common early symptoms of primary biliary cholangitis are pruritus (itching) and fatigue. If the disease continues to progress, primary biliary cholangitis is associated with an increased risk of liver-related mortality. As such, Gilead’s planned acquisition would give it rights to the potential best-in-disease treatment seladelpar, therefore helping to address this unmet need for PCB patients.

A continued focus on treatments for liver disorders

In recent months, several Big Pharma companies have made major deals centred on advancing treatments for liver diseases. This includes Boehringer Ingelheim’s $2 billion siRNA-focused collaboration agreement and Sanofi’s acquisition agreement in January 2024. Once closed, this deal will enable the company to add a potential best-in-class treatment for a rare lung and liver disease to its portfolio.