Symbiomix

Symbiomix Therapeutics has presented the first pivotal trial results of it’s drug candidate SYM-1219 for the treatment of bacterial vaginosis (BV).

SYM-1219 is a single-dose and novel oral product that includes secnidazole, an antibiotic with favourable pharmacokinetics (PK) allowing for single-dose oral therapy to treat BV.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

According to the firm, the trial results demonstrated that a single oral dose of SYM-1219 met the primary endpoint of clinical outcome responder (COR) and was well tolerated to treat BV.

Symbiomix Therapeutics chief medical officer Dr Carol Braun said: “Importantly, SYM-1219 achieved these clinical results with a single oral dose. These data suggest that treatment with SYM-1219 may lead to improved treatment outcomes for women with this serious disease.”

The multi-centre, prospective, randomised, double-blind and placebo-controlled study enrolled 215 women at 24 clinical sites across the US.

“These data suggest that treatment with SYM-1219 may lead to improved treatment outcomes for women with this serious disease.”

In the trial, the firm compared two different doses of SYM-1219 to placebo for the treatment of BV.

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.

The results for the primary endpoint showed that a single oral dose of SYM-1219 containing 2g of secnidazole achieved a 67.7% COR rate at 21 to 30 days post treatment in the modified intent to treat (mITT) population against 17.7% for placebo, said the company.

Symbiomix president and CFO Robert Jacks said: “The excellent results from this pivotal Phase II study allow us to begin to think ahead to the commercialisation of SYM-1219, as we are targeting a 2017 launch.”

The company is currently enrolling patients for a second pivotal trial of SYM-1219, which is expected to complete by the end of this year.

Image: Bacterial vaginosis. Photo: courtesy of Per Grinsted / Medicinsk Webdesign.