Sorrento Announces FDA IND Filing Today for COVI-AMG Neutralizing and High Potency Antibody Against SARS-CoV-2

Rhea-AI Summary

SRNE has submitted an IND filing for STI-2020 (COVI-AMG™) aimed at treating mild COVID-19 symptoms. This includes a safety and pharmacokinetic study in healthy volunteers. Following these initial trials, pivotal trials may lead to a potential Emergency Use Authorization (EUA). Preclinical data from gold Syrian hamsters infected with SARS-CoV-2 shows a strong neutralizing effect. This engineered antibody boasts ultra-high potency, requiring a lower effective dose for humans, facilitating a simple IV-push administration for outpatient treatment.

Positive

• IND filing for STI-2020 (COVI-AMG™) indicates progress in COVID-19 treatment.
• Pivotal trials expected to follow initial studies, potentially leading to Emergency Use Authorization (EUA).
• Animal model data shows strong neutralizing effects against SARS-CoV-2.
• Antibody designed for ultra-high potency, requiring lower doses for effective treatment.

Negative

• None.

• IND filing today for STI-2020 (COVI-AMG™) for the treatment of COVID-19 in patients with mild symptoms and a separate safety and pharmacokinetic study in healthy volunteers.
• These initial trials are expected to be followed by pivotal trials with a goal of potentially receiving an EUA (Emergency Use Authorization).
• Animal model data (golden Syrian hamsters infected with SARS-CoV-2) demonstrated a highly effective neutralizing profile.
• This antibody has been engineered for ultra-high potency, with an expected effective dose in humans to be much lower than current known antibodies being assessed by others in active trials, which would allow for a simple IV-push administration that is suitable in the outpatient set

FAQ

What is the purpose of the IND filing for STI-2020 by SRNE?

The IND filing is for the treatment of mild COVID-19 symptoms in patients and includes a safety and pharmacokinetic study.

What are the expected outcomes following the IND filing for STI-2020?

The initial trials are expected to be followed by pivotal trials that may lead to Emergency Use Authorization (EUA).

What does animal model data indicate about STI-2020's effectiveness?

Animal model data shows a highly effective neutralizing profile against SARS-CoV-2.

What is unique about the STI-2020 antibody compared to others?

STI-2020 has been engineered for ultra-high potency, requiring a much lower effective dose for humans.

How will STI-2020 be administered in outpatient settings?

The antibody allows for a simple IV-push administration, making it suitable for outpatient treatment.