Synlogic has dosed the first subject in its Phase I/IIa clinical trial of SYNB1618, a Synthetic Biotic medicine being developed to treat phenylketonuria (PKU).

PKU is a genetic disorder that leads to decreased metabolism and accumulation of the amino acid phenylalanine (Phe), which can cause seizures and cognitive impairment if not properly managed.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Under the single and multiple dose-escalation trial, SYNB1618 will be orally administered to healthy adult subjects.

The trial is also designed to investigate safety, tolerability, kinetics, and pharmacodynamics, as well as exploratory end-points associated with the ability of SYNB1618 to metabolise Phe.

“SYNB1618 is the second Synthetic Biotic medicine to enter clinical studies during the last year, this is a significant milestone for our therapeutic platform.”

In the first part of the trial, Synlogic will carry out a single-ascending dose (SAD) study in an inpatient setting over four days in healthy subjects who will be evaluated in up to six dose cohorts to identify the maximum tolerated dose (MTD) within the single dose range studied.

It aims to enrol up to 24 healthy subjects.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

After achieving MTD, the trial will enrol and treat a SAD cohort of up to four subjects, previously diagnosed with PKU.

The second part of the trial will involve a multiple-ascending dose (MAD) study that will be conducted in an inpatient setting over ten days. The subjects evaluated will be in up to four cohorts, treated at doses that will not exceed the MTD from the SAD part of the study.

Up to 32 healthy subjects are expected to be enrolled in this part of the trial, which aims to determine the MTD of SYNB1618 within the multiple-dose range.

Following the completion of the highest MAD cohort and the SAD PKU cohort, the trial will analyse a multiple-dose cohort of subjects previously diagnosed with PKU.

The MAD PKU cohort of the study plans to enrol up to 20 patients with PKU.

“SYNB1618 is the second Synthetic Biotic medicine to enter clinical studies during the last year,” Synlogic president Dr JC Gutiérrez-Ramos said.

“This is a significant milestone for our therapeutic platform and supports our vision of developing a robust pipeline of novel therapeutics,

“Applying genetic control and metabolic engineering elements of our proprietary synthetic biology platform to a well-characterised single probiotic strain has enabled us to develop Synthetic Biotic medicines with pharmacological potency and predictable biomarkers that allow us to establish dose responses, as well as reproducible manufacturing processes.”