Ascletis announces that the clinical trial application for the viral polymerase inhibitor ASC10 monkeypox indication has been approved by the US Food and Drug Administration

Ascletis Pharmaceuticals Limited (HKEx: 1672, "Ascletis") today announced that the U.
S
.
Food and Drug Administration (FDA) has approved a clinical trial (IND) application for ASC10 monkeypox indications.
Based on available data, the US FDA has approved a randomized, double-blind, placebo-controlled Phase Ib study of ASC10 at a dose of 800 mg twice daily to evaluate the safety, tolerability, efficacy, and pharmacokinetics
of ASC10 tablets in monkeypox virus patients.

ASC10 is an oral double prodrug
.
After oral administration, both ASC10 and the single prodrug monodrug monopyravir (molnupiravir) are rapidly and completely converted in vivo to the same active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931
.

Preclinical studies have shown that ASC10-A has broad-spectrum antiviral activity, including monkeypox virus and novel coronavirus
.
Ascletis has filed several patent applications worldwide for ASC10 and its use in the treatment of viral diseases, including monkeypox virus infection
.

Monkeypox virus belongs to the genus Orthopoxvirus and causes diseases similar to smallpox symptoms ^[1].

According to the World Health Organization (WHO), as of 15 November 2022, there have been more than 79,000 confirmed cases worldwide[2^] and monkeypox virus has been circulating in 110 countries^[2].

Of these, a total of 28,947 ^[3] confirmed cases
of monkeypox virus have been reported from the US.
The Region of the Americas is assessed by WHO as a high-risk area for monkeypox virus ^[2].

Experimental data in vitro monkeypox virus infection cell models show that ASC10-A has potent antiviral activity against monkeypox virus, indicating that ASC10 has the potential to be an effective therapy for monkeypox virus infection, which was commissioned by Ascletis to be conducted
by the IIT Institute (IITRI) of the Illinois Institute of Technology in Chicago, USA.
Researchers at the National Institute of Infectious Diseases in Tokyo, Japan, tested 132 drugs and showed that monoravir (active metabolite ASC10-A) and two other drugs had potent cellular antiviral activity in monkeypox virus infection models ^[4].

The remaining 129 drugs, such as remdesivir, favipiravir, sofosbuvir, and ribavirin, have no anti-monkeypox virus ^{activity [4].}

"There are no approved treatments for monkeypox virus infection worldwide, so it is imperative to develop a safe, effective and affordable monkeypox drug
.
The approval of ASC10 monkeypox indication IND by the US FDA further demonstrates Ascletis' independent research and development capabilities in the field of viral diseases and will accelerate our efforts to better address the global challenges
posed by the widespread spread of monkeypox.
" Dr.
Jinzi Wu, Founder, Chairman of the Board and Chief Executive Officer of Ascletis, said
.

       [1] #tab=tab_1

       [2] https://worldhealthorg.
shinyapps.
io/mpx_global/

       [3]

       [4] Daisuke Akazawa, Hirofumi Ohashi, Takayuki Hishiki, et al.
Potential anti-monkeypox virus activity of atovaquone, mefloquine, and molnupiravir, and their potential use as treatments.
bioRxiv preprint.
https://doi.
org/10.
1101/2022.
08.
02.
502485