Sorrento Therapeutics received clearance from the US Food and Drug Administration for the Investigational New Drug application (IND) to commence a Phase I clinical trial of its intranasal (IN) STI-2099 (COVIDROPS) for Covid-19.
The trial will analyse the safety and pharmacokinetics of IN STI-2099 in healthy subjects as well as individuals with mild Covid-19.
Sorrento noted the latest IND clearance from FDA is the first for a trial of intranasal dosage of a neutralising antibody against Covid-19.
Presently, the company is assessing an intravenous formulation of this potent antibody, STI-2020 (IV), in a Phase I trial in similar subject groups.
The reduced volume IV-push formulation of the therapy is being analysed against the SARS-CoV-2 virus’ dominant strain in the US and the UK variant.
Furthermore, the company intends to assess STI-2099 (IN) as a monotherapy or along with STI-2020 (IV) for treating recently diagnosed patients.
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The STI-2099 treatment is claimed to possibly stop the Covid-19 infection in the nasal passages in the initial stage before it spreads to the lungs.
It could also avert the development of severe disease if the infection has spread to the lungs.
If STI-2099 demonstrates to be safe and effective in trials, it could potentially avoid hospital admission or discharge Covid-19 patients admitted to the hospital quickly.
Following the initial stage trials, Sorrento plans to carry out a Phase II trial in patients with mild as well as moderate Covid-19, either as a monotherapy nasal application or along with the intravenous dosage.
Sorrento Therapeutics chairman and CEO Dr Henry Ji said: “We plan to use our intranasal formulation technology, which allows administering a drug via simple drops in the nose, for other antibodies we are currently developing with a goal of providing coverage against all variants of the SARS-CoV-2 virus that might evade inhibition from treatment with existing therapies.”
In January this year, the company obtained Brazilian health regulatory agency ANVISA authorisation to start a Phase IIa trial of COVI-MSC for the treatment of long Covid.