89bio is set to take a liquid formulation of its nonalcoholic steatohepatitis (NASH) candidate into a phase 2b clinical trial after reaching an agreement with the FDA. The new formulation is intended to provide patients with a more convenient administration method that supports compliance.
San Francisco-based 89bio took a frozen liquid formulation of its glycoPEGylated analog of FGF21 into human testing while working on an alternative that is better suited to larger trials and real-world use. The transition to the new formulation took a step forward this week when 89bio disclosed written guidance from the FDA that includes agreement on the use of the liquid product in a phase 2b trial.
“We believe the liquid formulation will provide a more convenient administration method which we know is critical for compliance for patients living with chronic conditions like NASH,” 89bio CEO Rohan Palekar said in a statement.
The development of a liquid formulation is part of a broader, ongoing effort to provide patients with convenient ways of administering BIO89-100. 89bio has also previously disclosed development of a freeze-dried formulation and work on a prefilled syringe. The biotech also plans to develop a pen-type auto-injector formulation.
That range of formulation and administration options could prove useful if 89bio needs to compete for the NASH market with developers of similar drugs. Akero Therapeutics and Bristol Myers Squibb are developing rival FGF21 analogs that will, respectively, be provided in lyophilized and liquid forms if they come to market.
89bio is taking its challenger into phase 2b on the strength of clinical data it frames as giving it an edge over the competition. The phase 1b/2a study linked BIO89-100 to significant declines in liver fat that were comparable to the results reported by Akero but free from some of the adverse events associated with that rival candidate.