Enzychem Lifesciences has reported that its lead candidate, EC-18, decreased the duration and occurrence of severe oral mucositis in a Phase II clinical trial in head and neck cancer patients.

A new small molecule oral immunomodulator, EC-18 is being analysed for chemoradiation-induced oral mucositis (CRIOM). It potentially aids in resolving inflammation and quick return to homeostasis.

Carried out in the US, the Phase II trial assessed EC-18 to treat oral mucositis in individuals with concomitant chemo-irradiation for mouth, hypopharynx, oropharynx, and nasopharynx cancers.

The first stage trial enrolled 24 participants, who were randomised to receive either 500mg or 1000mg or 2000mg dose of EC-18 or placebo.

Around 81 subjects were part of stage two, where they were given either a twice-daily dose of 2,000mg EC-18 or a placebo for nearly seven weeks.

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.

Data showed that EC-18 met the primary and secondary goals of efficacy and safety in the trial.

Subjects in the EC-18 arms had a decline in the duration of severe oral mucositis (SOM) through a short-term follow-up period versus the placebo group.

In addition, the oral immunomodulator reduced the occurrence of SOM through the conclusion of radiation treatment by 37.1% as against subjects on placebo.

The SOM occurrence through a short-term follow-up period dropped by 35.1% versus placebo.

In the trial, no serious adverse events (SAE) were observed between placebo and EC-18 arms.

Safety was similar across all groups, with the adverse events (AEs) linked to chemoradiation-associated toxicity.

Enzychem Lifesciences CEO and chairman Ki-Young Sohn said: “We are delighted to announce these positive results from our Phase II US study, which confirm that EC-18 is safe and well-tolerated.

“In addition, EC-18 may have a number of key advantages, including oral route of administration and convenience of use. We are excited to advance this novel candidate into a pivotal study and will also evaluate EC-18 for other radiation-induced inflammatory diseases.”

Based on the latest positive data from the Phase II trial, the company intends to seek breakthrough therapy designation for EC-18 from the US Food and Drug Administration (FDA) this year.

Furthermore, the oral treatment will be advanced to international Phase III trials.