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