The UK’s regulatory agency – MHRA (Medicines and Healthcare products Regulatory Agency), authorized Sorrento Therapeutics Inc (NASDAQ: SRNE) to commence phase 2 efficacy trial of Covi-drops.
Sorrento applied with supporting safety data gathered from a clinical trial conducted in the US to MHRA.
No severe side effects
It conducted the trial in the US with a dose of 60 mg of COVI-DROPs and achieved a verifiable safety profile. Sorrento did not notice any severe side effects in the subject of the clinical trial. The company is pleased to receive the approval of MHRA within one month of applying.
Enrolls 350 patients
Sorrento would enroll 350 asymptomatic patients for COVID in a phase 2 double-blind clinical study. It may also include patients with mild symptoms in the clinical trial.
It complements the phase 2 clinical trial undergoing currently in the US. Sorrento will also conduct a phase 2 clinical study in Mexico soon.
Sorrento administers intranasal COVI-DROPS to the recently infected subjects. It uses the same neutralizing antibody – COVI-AMG in this formulation.
This antibody acts against the SARS-CoV-2 virus and other variants such as the India Delta and UK Alpha variants found in the US and UK.
Sorrento will combine the Phase 2 clinical trial outcome from the UK with Mexico and the US results. It will seek EUA (Emergency Use Authorization) in Mexico, India, UK, the EU, and the US on assessing that COVI-DROPS are effective and safe against the SARS-CoV-2 virus.
Inks a pact with Mayo Clinic
Sorrento signed a pact with Mayo Clinic in June 2021 to carry out clinical proof of concept on humans using S-LDDS (Sofusa Lymphatic Drug Delivery System) technology.
The drug delivery platform – Sofusa administers biologic therapies into the lymphatic system and through the skin and improves the safety and efficacy of immuno-oncology therapies.
Sofusa also allows delivery of reduced dose to the lymphatics than subcutaneous injections or traditional systemic infusions.
As part of this agreement, the company will commence a phase 1b clinical trial of Ipilimumab Intra-Lymphatically with its Sofusa DoseConnect in Metastatic Melanoma subjects.
Sorrento already received FDA approval to commence Phase 2a clinical trial of STI-3031 to treat advanced urothelial carcinoma.
Sorrento stock trades at $8.60 (down 0.81%) on June 18, 2021. It is a best buy around $7 for smart gains in the future.