Phase 2 Trial of SYNB1618 in PKU Likely to Be Delayed Due to COVID-19

Phase 2 Trial of SYNB1618 in PKU Likely to Be Delayed Due to COVID-19

A planned Phase 2 clinical trial of Synlogic’s SYNB1618, an investigational treatment for people with phenylketonuria (PKU), is expected to be delayed due to the COVID-19 pandemic, the company said.

Although preparations for the trial will continue, enrollment of participants should occur only when it is safe to go to clinical sites, Synlogic said in a press release.

PKU is a genetic disorder characterized by the toxic buildup of phenylalanine, an amino acid (the building blocks of proteins) acquired from the diet. It results in tissue damage, primarily in the brain.

SYNB1618 consists of a type of bacteria (E. coli Nissle) that has been genetically modified to quickly break down phenylalanine into non-toxic molecules. E. coli Nissle is a probiotic — live microorganisms that improve gut health — that produces two enzymes to degrade phenylalanine, called phenylalanine ammonia lyase and L-amino acid deaminase. Breaking down phenylalanine generates biomarkers in urine that enable monitoring SYNB1618’s activity.

Supported by positive findings in mice and monkeys, a Phase 1/2 clinical trial (NCT03516487) in 70 healthy volunteers suggested a good safety profile for a solid oral formulation of SYNB1618.

These results also yielded data on the optimum dosing strategy for SYNB1618, which was planned to be implemented in a Phase 2 study evaluating the therapy’s safety and effectiveness in people with PKU.

The Phase 2 trial was set to begin in the first half of this year. However, owing to the current pandemic, it is generally being recommended that people avoid going to hospitals — as would be necessary for the trial — unless there is an urgent medical need.

“The COVID-19 pandemic has generated global challenges and we have all had to assess and redefine our priorities,” said Aoife Brennan, Synlogic’s president and CEO. “Like others in our industry we have moved quickly to respond; prioritizing the safety of patients and our employees, alleviating the burden on our clinical trial sites, while continuing to execute on our business strategy and work within institutional and government guidelines.”

Another therapy candidate being developed by Synlogic is SYNB1891, a potential cancer treatment currently being evaluated in people with advanced solid tumors or lymphoma in a Phase 1 trial (NCT04167137). The study has already dosed patients. Synlogic said it will will proceed with current participants, but recruitment of new participants will be slowed due to the pandemic, which likely will delay results.

“There is still a great deal of uncertainty as to the duration and ultimate impact of this pandemic on the healthcare system and we continue to evaluate the situation as it evolves,” said Richard Riese, MD, PhD, Synlogic’s chief medical officer. “We will continue to execute on our overall development plans while adjusting to our new reality. We believe our updated plans will not only protect the health and safety of the patients that we serve in these trials but aid our clinical sites as they navigate tremendous operational and caregiving challenges in response to the pandemic,” he said.

Beyond these clinical trials, Synlogic is continuing development in other realms, including a program in enteric hyperoxaluria. The company said it has taken steps to promote the safety of its employees during the pandemic, such as requiring that non-essential personnel work from home.

Adding that it expects to have enough resources to continue operations through 2022, the company also said it will look into potential collaborations to explore its Synthetic Biotic platform to develop ways to prevent COVID-19.

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