Synlogic (NASDAQ:SYBX) initiated Synpheny-3, a global, Phase 3 study evaluating the efficacy and safety of SYNB1934 as a potential treatment for phenylketonuria (PKU), a rare inherited disorder that causes an amino acid, phenylalanine, to build up in the body.
Synpheny-3 is a randomized, placebo-controlled clinical trial that will enroll about 150 patients and will include patients ages 18 years and older. An initial subset of data from patients in Part 1 will be used to assess the opportunity to lower the age of enrollment to 12 years of age. Study participants may follow their usual diet while participating in the trial.
Synpheny-3 is expected to be conducted at approximately 30 clinical sites across the U.S., Canada, Germany, Denmark, Israel, Turkey and Georgia. The study offers opportunities to participate in person, or in a virtual or hybrid format.
Citing the importance of Synpheny-3, Synlogic is directing resources towards its late-stage portfolio of product candidates for rare metabolic diseases. Changes include prioritizing activities to the pivotal and pediatric studies of SYNB1934 for PKU, and advancing to Phase 2 for SYNB1353 for homocystinuria, as well as research activities that support the current clinical pipeline and the ongoing collaboration with Roche.
As a result, Synlogic reduced its workforce by approximately 21%, which is expected to extend its cash runway further into the second half of 2024. The company estimates that it will incur approximately $900,00 of costs in connection with the reduction in the workforce.
