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Dr. Falk Pharma GmbH, a Germany-headquartered research-based pharmaceutical company specialising in digestive and metabolic medicine, China's Allianthera (Suzhou) Biopharmaceuticals Co., and its affiliate Allianthera Boston, Inc., a clinical stage biotechnology company focusing on novel drug research and development in immunology and inflammatory diseases, have announced the signing of an agreement on the co-development, license option, manufacturing, and commercialisation of the novel small molecule ATB102, an aryl hydrocarbon receptor (AhR) agonist currently undergoing a phase 1 clinical trial in the United States.
Under the terms of the newly signed agreement, Dr. Falk Pharma and Allianthera will collaborate to develop ATB102 for inflammatory bowel disease (IBD), with an initial focus on refractory moderate-to-severe ulcerative colitis (UC).
Dr. Falk Pharma will enjoy the exclusive rights to license, manufacture, and commercialise ATB102 worldwide, excluding Mainland China, Hong Kong, Macau and Taiwan. As part of the agreement, Allianthera will receive a signing fee, significant development milestone payments as well as a licensing fee, followed by sales milestone payments and tiered royalties.
ATB102, developed by Allianthera, is a gut-enriched AhR agonist which represents a new therapeutic approach for IBD. It is designed to specifically target inflammation and mucosal damage within the gastrointestinal tract, with a particular emphasis on treating refractory moderate-to-severe UC. In pre-clinical research, ATB102 supports immune homeostasis, restores mucosal barrier integrity, and confers anti-fibrotic and anti-oxidative benefits, making it a potential new option for patients unresponsive to or relapsed from existing therapies.
Dr. Falk Pharma, in cooperation with its fully-owned subsidiary Losan Pharma GmbH, a leading contract development and manufacturing organisation (CDMO) partner and formulation expert, will develop an innovative colonic-release formulation of ATB102 to complement the current immediate release formulation.
