The Company has adequate clinical supplies for the ongoing NASH trial and the planned SHTG trial.
NewBIO89-100 Preclinical Data
“Our new preclinical data demonstrates thatBIO89-100 has similar activity to rhFGF21 at FGF receptors 1c, 2c and 3c, suggesting thatBIO89-100 could reproduce the beneficial metabolic benefits of the native hormone, which may translate into clinical benefits for patients with NASH and SHTG,” said Dr. Hank Mansbach, Chief Medical Officer of 89bio.
Activation of the FGF receptors 1c, 2c and 3c, together with theco-receptor ß-klotho, are critical to the signaling of FGF21 and are believed to be responsible for the beneficial metabolic effects observed. In an in vitro study of receptor agonism,BIO89-100 was shown to have activity at very low nanomolar concentrations in cellsco-expressing ß-klotho and each of FGF receptors 1c, 2c or 3c. The EC50 (concentration at which one half of the maximal FGF receptor agonist effect is observed) forBIO89-100 was similar across FGF receptors 1c, 2c and 3c and comparable or superior to that of rhFGF21 in this functional assay. An EC50 could not be calculated for rhFGF21 orBIO89-100 at FGF receptor R4.
Investors are encouraged to review the Company’s updated Corporate Presentation slide deck that provides an overview of the Company’s business and is available under the “Investors” tab of the Company’s website at www.89bio.com, or by request to the Company.
About 89bio
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate,BIO89-100, is being developed for the treatment of NASH. The company also intends to developBIO89-100 for the treatment of SHTG.BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, 89bio’s expectations regarding plans for its clinical programs and clinical trials, the association of preclinical data with potential clinical benefit and timing of anticipated milestones. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the
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