Special Report I
Enzychem Lifesciences recently announced positive results for its lead compound EC-18 in chemoradiation-induced oral mucositis (CRIOM) for head and neck cancer patients, an area of significant unmet medical need for patients undergoing cancer therapy. There are currently no FDA-approved therapies for CRIOM for head and neck cancer patients. All the currently available therapies are palliative care that only reduce symptoms and pain.
Chemoradiation-induced oral mucositis (CRIOM) is an acute inflammation of the oral mucosa following systemic chemotherapy and radiation therapy. It can cause several problems including pain, malnutrition as a result of an inability to eat and increased risk of infection due to open sores in the mucosa. The symptoms have a significant effect on the patient’s quality of life-including pain, nutritional problems as a result of inability to eat, and an increased risk of infection due to open sores in the mouth. More importantly, it can also lead to sub-optimal cancer treatment by limiting the doses and duration of the chemotherapy and radiation.
In 2020, the annual global incidence of Head and Neck Cancer (HNC) was estimated to be around 930,000 and the number is expected to increase. In the United States, the annual incidence of HNC is approximately 66,000 and about 75% or 50,000 would receive CRT as the cancer treatment. Among those who receive CRT, over 90% or 45,000 of the patients would develop some degree of oral mucositis (OM).
Enzychem’s EC-18 successfully met both its primary and secondary endpoints in terms of efficacy and safety in the Phase 2 U.S. study. Patients on EC-18 reported a reduction in the duration of severe oral mucositis (SOM) through a short-term follow-up period from 13.5 days to 0 day (100% reduction) in comparison to the placebo arm. EC-18 also reduced the incidence of SOM through completion of radiation by 37.1% in comparison to the placebo arm (65% vs. 40.9%). The incidence of SOM through a short-term follow-up period was reduced by 35.1% in comparison to the placebo arm (70% vs. 45.5%).
No serious adverse events (SAE) were reported between placebo and EC-18 groups and none of the SAEs were related to EC-18. Safety was also comparable across arms with all adverse events (AEs) attributable to expected chemoradiation-related toxicity. One-year long-term follow-up for tumor outcomes is ongoing.
What the Experts Say About EC-18
According to Dr. Christina Henson, Residency Program Director for Radiation Oncology at Oklahoma University, and principal investigator for Enzychem’s Phase 2 CRIOM study, “Oral mucositis is a common and debilitating side effect experienced by so many of our patients, with no promising therapies up to this point. That we’ve proven clinical efficacy of EC-18, especially one derived from nature, is incredibly exciting and holds the potential to decrease opioid pain medication use and also to avoid treatment breaks and delays that can adversely impact cancer prognosis.”
“The results of the Phase II trial of EC-18 suggest this medication is safe and effective at reducing severe oral mucositis in patients undergoing chemoradiation for head and neck cancer. This is an incredibly difficult treatment for patients, and EC-18 is a promising new therapy that may provide significant benefits to patients. I look forward to seeing the results of the upcoming Phase 3 trial of EC-18,” added Dr. Daniel Clayburgh, Associate Professor of Otolaryngology at Oregon Health & Science University.
“Severe CRIOM affects almost 75% of patients being treated with concomitant chemoradiation for head and neck cancers with symptoms that are so severe that they challenge a patients’ ability to tolerate optimal treatment,” said Dr. Stephen Sonis, Professor, Harvard School of Dental Medicine and Key Advisor for the U.S. Phase 2 CRIOM Study. “Despite its frequency and burden it places on patients and their caregivers, there is no approved pharmaceutical intervention. The results observed with EC-18 support its continued development and offer encouragement as an effective CRIOM therapy.”
There is no doubt that new therapies for oral mucositis are urgently needed. Enzychem Lifesciences’ positive Phase 2 study data for its lead candidate EC-18, a small molecule oral immunomodulator could be a positive addition for patients with severe oral mucositis (SOM) in head and neck cancer patients undergoing concurrent chemoradiation. Experts also agree, and we look forward to hearing updates from the company as the clinical program progresses.
Headquartered in Seoul, South Korea, Enzychem Lifesciences (KOSDAQ:183490) is developing novel small molecule therapeutics to target fundamental pathways in inflammation, patients with significant unmet needs in oncology, inflammatory, and severe respiratory diseases. Enzychem lead candidate, EC-18, has successfully completed US FDA phase 2 clinical testing in cancer patients. In response to the Korean government pledge for a Vaccine Hub, Enzychem has formed a consortium with several domestic companies in Korea to manufacture vaccines against COVID-19. The company plans to leverage its expertise in lipid chemistry and manufacturing to establish itself as a regional producer of lipid-based formulations for improved delivery of nucleic acids and other biologicals and drugs. For more information, please visit www.enzychem.com.