Clinical-stage biopharmaceutical major, 89bio Inc, has reportedly announced plans for sharing topline efficacy, safety, and tolerability data from the Phase 1b/2a study of its BIO89-100 in NASH.
For the uninitiated, 89bio Inc., is a clinical-stage biopharmaceutical player focusing on the commercialization and development of innovative therapies for the treatment of cardio-metabolic and liver diseases. The company has its headquarters in San Francisco and conducts operations via Herzliya in Israel.
Sources state that bio89’s lead product candidate, BIO89-100 is a glycoPEGylated analog of FGF21 that is being developed for the treatment of severe hypertriglyceridemia and NASH. The company has optimally engineered BIO89-100 via the deployment of a proprietary glycoPEGylation technology for the purpose of balancing longer dosing interval and efficacy.
The preclinical studies of BIO89-100 showcased remarkable improvements in fibrosis, hepatic steatosis, and injury. In the Phase 1a clinical trial conducted by BIO89-100 in healthy volunteers, the candidate demonstrated durable and robust improvements in a favorable tolerability profile, key lipid markers, and a long half-life supporting the potential for weekly or biweekly dosing.
According to Hank Mansbach, the Chief Medical Officer of 89bio, the company’s new initiative is being built on the company’s strategy to leverage FGF21’s biology for the purpose of bringing meaningful benefit to patients across a broad range of serious diseases having high unmet requirements.
Mansbach has further stated that the current SHTG therapies do not address the broad range of metabolic issues that are faced by these patients, resulting in the increased risk of NASH and cardiovascular events, adding that the company’s early clinical data reveals that BIO89-100 could offer broad metabolic benefits and also deliver durable and robust reductions in triglycerides.
This is an effective indication of BIO89-100’s potential for being a highly differentiated new therapy for this condition, added Mansbach.
According to a statement by the company, the Phase 2 clinical trial of BIO89-100 is a double-blind, multi-center, randomized, placebo-controlled study with the primary endpoint being the reduction in fasting triglycerides from the baseline.