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RHB-107 (Oncology/GI)

RHB-107 (INN: upamostat) (formerly MESUPRON) is a proprietary, first-in-class orally-administered protease inhibitor targeting pancreatic cancer and inflammatory gastrointestinal diseases.

RHB-107 presents a new, new non-cytotoxic approach to cancer therapy with several potential mechanisms of action to inhibit tumor invasion and metastasis.

RHB-107 was granted FDA Orphan Drug designation for the adjuvant treatment of pancreatic cancer.

RedHill acquired the worldwide exclusive development and commercialization rights to RHB-107 (excluding China, Hong Kong, Taiwan and Macao) for all indications from Munich-based WILEX AG in June 2014.

WILEX AG completed several clinical studies with RHB-107 for different indications, including several Phase I studies and two Phase 2 proof-of-concept studies. The first Phase 2 study in locally advanced non-metastatic pancreatic cancer and the second study in metastatic breast cancer, established its safety and tolerability profile. The Phase 2 studies with RHB-107 in both indications suggested activity as measured by both tumor response rate and overall survival of patients when administered in combination with first-line chemotherapeutic agents.

RedHill is also evaluating utilization of RHB-107 in several inflammatory gastrointestinal indications.