Gilead Sciences Inc. and LEO Pharma have partnered to accelerate the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases.

STAT6 is the transcription factor essential for signaling of IL-4 and IL-13 cytokines, which are well-established targets for Th2-mediated inflammatory diseases like atopic dermatitis, asthma, and COPD, among others. Preclinical evidence indicates that targeting STAT6 could treat a wide range of patients, offering an oral alternative for those currently receiving injectable biologics.

Under this partnership, Gilead will acquire LEO Pharma’s comprehensive preclinical oral STAT6 small molecule inhibitors and targeted protein degraders. Gilead will lead further development efforts for the oral programs, while LEO Pharma will lead development for potential topical formulations of STAT6 inhibitors.

“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, M.D., Executive Vice President, Research, 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.”

“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,” said Christophe Bourdon, CEO of LEO Pharma. “This partnership acknowledges LEO Pharma’s scientific capabilities and strengthens our commitment to innovate for people with skin diseases.”

Gilead will have global rights to develop, manufacture, and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to potentially co-commercialize oral programs for dermatology outside the United States. LEO Pharma will hold exclusive global rights to STAT6 topical formulations in dermatology.