LEO Pharma and Gilead Will Develop STAT6 Program for AD and Other Inflammatory Diseases

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Last week, LEO Pharma announced a strategic partnership with biopharmaceutical company, Gilead Sciences, Inc. to develop programs for their STAT6 (signal transducer and activator of transcription 6).¹ The small molecule oral therapy will be used to treat patients with chronic inflammatory diseases, including atopic dermatitis (AD), asthma, and COPD.

“As we continue to expand our inflammation portfolio, we're committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through mechanisms that block major pathogenic pathways, eliminate pathogenic cells, tolerize the immune system, and restore cell function,” said Flavius Martin, MD, Executive Vice President of Research at Gilead Sciences. “By partnering with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring forward an oral option for patients suffering from chronic inflammatory conditions.”¹

STAT6 is the transcription factor needed for IL-4 and IL-13 cytokine signaling, which are the clinically validated targets for Th2 mediated inflammatory conditions like AD. Preclinical research from LEO Pharma has shown promise in providing an oral alternative to injectable biologics, which can appeal to a wider patient population.

Through this collaboration, Gilead will lead the manufacturing efforts of this program and will acquire preclinical oral STAT6 small molecule inhibitors and targeted protein degrades. The addition of the program will strengthen Gilead’s existing inflammation research portfolio.

Additionally, LEO Pharma will lead the development of any topical STAT6 formulations for dermatology and will hold these global rights. They will also have the ability to co-commercialize oral programs outside of the United States.

According to the agreement, LEO Pharma is eligible to receive up to $1.7 billion in total payments, which includes an upfront payment equal to $250 million. Furthermore, each company may also receive tiered royalties; LEO Pharma can earn these on the sales of oral STAT6 products while Gilead can earn these on the sales of topical STAT6 formulations.

“STAT6 holds potential for treating various inflammatory diseases, including outside dermatology. This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 program and maximize its potential in dermatology and beyond,” CEO of LEO Pharma, Christophe Bourdon, said in a statement. “This partnership acknowledges LEO Pharma’s scientific capabilities and strengthens our commitment to innovate for people with skin diseases.”¹

Reference

1. Gilead and LEO Pharma Enter Into Strategic Partnership to Accelerate Development of Oral STAT6 Program With Potential in Multiple Inflammatory Diseases. News release. LEO Pharma. January 11, 2025. Accessed January 13, 2025. https://www.leo-pharma.com/media-center/news/2025-gilead-and-leo-pharma-enters-into-strategic-partnership