SRNE is a biotechnology company that claims to apply cutting-edge science to create the best effective therapies in order to improve the lives of people suffering from cancer, intractable pain, and COVID-19. The stock of the company has gained in after-hour since the company has got clearance from the FDA to Proceed with Phase 1 Study for STI-2099 (Intranasal COVIDROPS).
What is happening?
The company has got FDA clearance to start their phase-1 safety and pharmacokinetic study for STI-2099 (Coviddrops) in both healthy volunteers and outpatients with mild COVID-19 disease. The test can be done with or without a simultaneous intravenous injection of STI-2020. This is going to be the first step followed by a phase 2 trial in both mild and moderate COVID-19 patients. This is a huge achievement for the company since it is the first FDA clearance of a clinical trial of intranasal administration of a neutralizing antibody against SARS-CoV-2 virus.
The company claims that the treatment they have discovered for COVID-19 has the potential to fight the infection before it spreads in the lungs, or if in any case the infection has already been spread in the lungs, it prevents the development of severe infections.
If the trial of this treatment becomes a success, it means that the treatment is safe and effective. STI-2099 has the potential to prevent hospitalization or discharge COVID-19 patients faster. The CEO of the company says that they are planning to use intranasal formulation technology through which the drug that is in the form of drops could be used in the patients via nose. While for other antibodies they are currently developing a goal of providing coverage against all variants of the SARS-CoV-2 virus that might evade inhibition from treatment with existing therapies.