Earlier this week, the biotechnology company Sorrento Therapeutics Inc. ($SRNE) went down 8.04% after a difficult trading day. The company foresees an upward move following the release of positive preclinical data from an IND-supporting study on the intravenous COVI-AMG™ nAb (STI-2099 or COVI-DROPS™). It reduced the symptoms of COVID-19 at a very early stage during tests with infected hamsters.
Update on COVI-DROPS™ and COVI-AMG™
As a result, Sorrento announced today that it is preparing its IND applications for both the intravenous COVI-DROPS™ nAb (STI-2099) and intravenous COVI-AMG™ nAb (STI-2020), where the applications are expected to be submitted in November 2020 .
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Why the infected hamster are so important to the preclinical study can be inferred from the following observations. Intravenously dosed hamsters recovered from the infection with marked differences in weight loss between the IgG-control and COVI-AMG™ candidates reaching a maximum on the fifth day after infection. Intranasally COVI-DROPS™ treated hamsters already showed symptoms of prevention during the disease progression on the second day of the experiment. This was noted by limited weight loss at a very early stage of infection and reduced duration of disease symptoms compared to hamsters given previous medication.
With that, COVI-DROPS™ is now presented as an intranasal administration of a highly effective neutralizing antibody against COVID-19. Its main feature is that it allows access to the essential antiviral treatments. Sorrento admits it is optimistic about the lastest developments and expects to see the same results in planned clinical trials with patients. Sorrento thereby indicates that it intends to investigate the intranasal formulation of COVI-DROPS™ STI-2099, in the form of simple intranasal drops, in a very short term with patients who have recently tested positive for COVID-19.
Based on scaling methods, the 500 µg single dose of STI-2020 (IV) or STI-2099 COVI-DROPS™ (IN) administered to the hamsters in the preclinical studies would be equivalent to a human dose of approximately 45 mg antibody.
The process is explained above with an clear illustration.
In Figure 1A the current neutralization antibodies are administered in large doses, requiring infusions for several hours in the hospital. These neutralization antibodies are already under development or are being evaluated under FDA / EUA approval.
In Figure 1B it is made clear that the intravenous COVI-AMG™ nAb (STI-2020) may only require an intravenous slow push, due to the high potency indicated in the hamster models so far.
In Figure 1C it is illustrated that the intranasal COVI-DROPS™ (STI-2099) should preferably be administered as simple intranasal drops. This would avoid not only the need for an intravenous infusion or injection, but also avoid an inevitable hospital visit.
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