Breast cancer patients testing Enzychem’s cheaper Mosedipimod, hopes for FDA’s approval

Enzychem Lifesciences, the largest life sciences company by market capitalization in South Korea’s KONEX Stock Exchange, has kicked off the dose-escalation stage of a global phase 2 trial of EC-18 today, a synthetic palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (Mosedipimod), intended for patients with Chemotherapy-Induced Neutropenia (CIN). Enzychem also said it hopes to have EC-18 be approved by the FDA.

Announcing the phase 2 testing on Monday, the company said that the multicenter study of EC-18, the world’s first oral medicine candidate to prevent and treat Chemotherapy-Induced Neutropenia (CIN), will begin dosing its first patient in the Asan Medical Center of Seoul, Korea.

Alexander Fleming, M.D., Chief Technology Officer of Enzychem Lifesciences, said: “Having established the Phase 2 study in Korea and the U.S., we are now focused on augmenting proof of concept data for EC-18 in management of severe chemotherapy-induced neutropenia patients with advanced breast cancer.”

Unlike the current standard care for CIN, G-CSFs, EC-18 will be produced in the form of soft oral gelatin capsules, which is intended to considerably enhance the convenience of regularly taking the medicine, the company said.

Cheaper treatment

Enzychem expects chemically synthesized EC-18, on the other hand, to significantly reduce the cost of current treatment, as the currently approved formulations of G-CSFs for the treatment of CIN are administered intravenously as injectables, which is one of the main reason for the high cost of therapy.

Furthermore, owing to different mechanism of action (MoA) of EC-18, which is controlling inflammation through neutrophil modulation, Enzychem expects EC-18 to address medical needs unmet under current treatment. Presently, the most serious adverse reactions reported in patients taking G-CSF products are splenic rupture, bone pain, serious allergic reactions and potential for tumor growth stimulatory effects on malignant cells. Enzychem quoted FDA’s prescribing information, “The G-CSF receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type cannot be excluded.”

Enzychem’s hopes that EC-18 will help fight cancer growth and inflammation, as well as immune diseases including psoriasis, rheumatoid arthritis, asthma, atopic dermatitis, and sepsis. Enzychem Lifesciences said it is preparing to submit an investigational new drug application (IND) for the indication of chemotherapy and radiation induced oral mucositis (CRIOM) during June.

Enzychem Lifesciences’s intellectual property portfolio comprises use and process patents, and patent applications that the company believes are necessary for the development and commercialization of EC-18. In aggregate, Enzychem owns over 169 active patents and patent applications with over 85 of the granted patents coming worldwide, especially in the U.S., Europe, and Japan.

Enzychem Lifesciences Chief Executive Officer Ki-young Sohn said: “Enzychem is investing 30% of the company’s total annual sales into R&D. Enzychem Lifesciences won the award for best R&D Company at the Korean Venture Business Association in 2017, and it will become a leading global biopharmaceutical company through new drug development.”