China guidelines point to HIV protease inhibitors as potential coronavirus treatment

Ascletis is seeking the approval of China’s NMPA for emergency use of its protease inhibitors to treat 2019-nCoV coronavirus after the government released guidelines suggesting AbbVie’s Kaletra as a treatment for the virus.

In a Wednesday regulatory filing, Ascletis Pharma Inc. (HKEX:1672) said it believes protease inhibitors have potential to treat the novel coronavirus, which was first identified in Wuhan. The company cited structural similarities between the HIV and 2019-nCoV proteases. It also said that clinical testing has demonstrated the efficacy of Kaletra, a combination of ritonavir with lopinavir -- two HIV protease inhibitors -- to treat another coronavirus: SARS.

According to Ascletis, one patient infected with 2019-nCoV has improved rapidly on Kaletra. The company said additional testing will be required to establish the efficacy of Kaletra. The Wuhan Jinyintan Hospital, which specializes in infectious diseases, has registered a clinical trial of Kaletra to treat 2019-nCoV infection.

The company submitted its application on Jan. 25. to the National Medical Products Administration for emergency use of ritonavir alone or in combination with ASC09 to treat 2019-nCoV infection. The company’s stock gained HK$0.99 (33%) to HK$3.97 Wednesday.

The guidelines, released by the National Health Commission and the National Administration of Traditional Chinese Medicine, also list inhaled IFNα as a treatment option, while cautioning that there are no known effective antiviral therapies for the disease.

AbbVie Inc. (NYSE:ABBV) said last week that it will donate RMB10 million ($1.4 million) of antiviral medications to China.

Although multiple companies are mobilizing to address the emerging coronavirus, new therapies may be at least a year away (see “The Race is on to Develop Therapies and Vaccines for The Coronavirus Outbreak” & “J&J Developing Coronavirus Vaccine, at Least Nine Other Vaccines Under Development”).

An NDA for Ascletis’ generic version of AbbVie’s Norvir ritonavir to treat HIV-1 infection is under NMPA review. On Dec. 30, 2019, the company submitted an application for clinical testing of ritonavir in combination with ASC09, another of its HIV protease inhibitors which has completed Phase IIa testing for HIV-1 infection. Ascletis has exclusive rights to develop and commercialize ASC09 in mainland China and Macau from Johnson & Johnson (NYSE:JNJ).

Targets: IFNα - Interferon α

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