Hyundai Bioscience to request a fast track processing for its monkeypox treatment drug with the FDA

• Under the 'Animal Rule', efficacy established from animal studies may lead to the approval of monkeypox treatment
• US research team, "Niclosamide is the most promising candidate to treat monkeypox"

SEOUL, South Korea, May 25, 2022 /PRNewswire/ -- Hyundai Bioscience will go straight to the US with its broad-spectrum antiviral drug candidate to treat monkeypox.

Hyundai Bioscience has decided to submit a request for a fast track processing to the U.S. Food and Drug Administration (FDA) for CP-COV03, an oral antiviral medicine for the treatment of monkeypox, which it developed as a treatment for COVID-19.

Hyundai Bioscience's decision came after it learned, through a US law firm that specializes in biotechnologies, that CP-COV03 may be granted a fast track processing under the Animal Rule. Animal Rule is sort of a fast-track adopted by the U.S. FDA for new drugs (e.g., smallpox or monkeypox), as an alternative to conventional clinical trials, allowing approval of new drugs and biological products based on efficacy data obtained solely from animal testing in situations infeasible or unethical to conduct clinical testing on humans. TPOXX is a treatment for smallpox developed with efficacy established from animal testing by Siga Technologies, a US pharmaceutical company, and the FDA approved it as a treatment for smallpox in 2018 under Animal Rule. There are 12 other new drugs the FDA applied the animal rule pathway for granting marketing authorization.

Hundai Bioscience plans to submit data related to results of animal studies of CP-COV03 to the FDA as swiftly as possible.

Niclosamide, the active ingredient of CP-COV03, has already been shown to have excellent efficacy against monkeypox type of virus, according to a recently published research.

Researchers at Kansas State University in the US published a study result in which niclosamide demonstratably lowered the proliferation of vaccinia virus (VACV), a virus within the same family as the monkeypox virus, to a whopping one-hundredth level even at a concentration as low as 1 micromole. This study was published in the international scientific journal Vaccines in July 2020. Among a total of 3,228 existing drugs, the research team examined them to find what is cell-directed and showed efficacy without causing resistance, ending up with four candidates, among which niclosamide was the only one that received FDA approval.

If the FDA decides to apply the Animal Rule to CP-COV03, whose drug safety has already been demonstrated in animal studies, it may be granted marketing authorization readily after efficacy on animals is confirmed, following pharmacokinetics (PK) and human safety results from the ongoing COVID-19 phase II clinical trial.

Accordingly, Hyundai Bioscience has decided to accelerate the speed of current phase 2 study of CP-COV03 for COVID-19 by expanding the number of hospitals where clinical trials take place as of next week.

Niclosamide-based CP-COV03, a cell-directed drug as opposed to other virus-directed drugs, is a broad-spectrum antiviral drug candidate that promotes cellular autophagy, which induces cells to recognize virus as foreign substance and then destroy it, which is why the scientific community considers the drug's pharmacological mechanism of action applicable to almost all types of viral infections.

"CP-COV03 is a universal antiviral drug with niclosamide as the main ingredient, which can fight many nearly all types of virus," said Oh Sang Ki, CEO of Hyundai Bioscience. He went on to highlight, "If CP-COV03 is approved as a treatment for monkeypox with the FDA's fast-track designation, we will witness the birth of another innovative antiviral drug comparable to penicillin - the epitome of the 20th century's 'wonder antibiotics'."

SOURCE Hyundai Bioscience