AP-003

Interferon Alpha-2b for Inhalation

Indication: Early stage COVID-19

AP-003 is Altum’s patented interferon alpha 2b inhalation formulation. Its first target indication is early stage COVID-19 disease.

All interferons (IFNs) share several common effects: they are antiviral agents and they modulate functions of the immune system. First identified in 1957 by Aleck Isaacs and Jean Lindenmann, IFNs were so named for their ability to “interfere” with viral replication by protecting cells from virus infections. IFNs are generally classified into 3 groups (IFN-1, IFN2 or IFN-3). Different IFNs are produced by different cell types and under different conditions. While IFNs belonging to all three classes are important for fighting viral infections and for the regulation of the immune system, IFN-1s are among the first cytokines produced during a viral infection. IFN-1s therefore play a primary role in the anti-viral response in the infected host, in blocking virus replication and spread. IFN-1s are produced by fibroblasts and monocytes, and are subdivided into sub-classes, the most ubiquitous ones being IFN-α and IFN-β.

IFN-1 treatment has been studied against coronaviruses including MERS-CoV, SARS-Cov-1 and now SARS-CoV-2 (the causative agent of COVID-19). It is of particular interest that coronaviruses are able to disrupt the IFN signaling pathway. Of the three coronaviruses which cause severe human disease, SARS-CoV-2 displays substantial sensitivity to IFN-α. Studies in COVID-19 patients show that IFN-α2b inhalation reduces the infection rate of SARS-CoV-2.

Practice guidelines from China recommend using inhaled IFN with or without other anti-virals to treat COVID-19. Retrospective analyses show inhaled IFN-α2b compared to anti-viral therapy leads to more rapid viral clearance in COVID-19.

AP-003 is Altum’s proprietary IFN-α2b inhalation formulation. A randomized, double-blind, placebo controlled trial of AP-003 in COVID-19 is projected to start shortly.

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