Shares of Equillium, Inc. (NASDAQ: EQ) soared 28.50% in the pre-trading hours after the company announced that it has got the ‘Study May Proceed Letter’ from the US Food and Drug Administration (FDA). After receiving a green signal from the FDA biotechnology company is planning to commence the COVID-19 Phase III trial, titled EQUINOX.
In the EQUINOX Phase III trial, the company will officially enroll a total of 800 patients in the fourth quarter of 2020. FDA has also specified that the promising result of the study will also support the regulatory filing of a Biologic License Application (BLA).
Equilium, Inc. (NASDAQ: EQ) shares were trading up 33.00% at $7.93 at the time of writing on Friday. It has a trading volume of 2.02 million in the pre-market trading session on Friday. Equilium, Inc. (EQ) share price went from a low point of around $2.20 to briefly over $27.05 in the past 52 weeks. It has moved up 172.73% from its 52-weeks low and moved down -77.82% from its 52-weeks high. EQ market cap has remained high, hitting $144.84 million at the time of writing.
Itolizumab is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. It is used to treat COVID-19 patients suffering from Acute Respiratory Distress Syndrome (ADS). Itolizumab has the ability to control cytokine cascade that is the basis of multiple complications in COVID-19 Patients. Patients have experienced various complications such as organ failure, blood clots, and tissue damage.
COVID-19 is continuously spreading all over the world and has infected many patients all around the globe. Equillium is striving to provide treatment to COVID-19 patients. In the Phase III trial, patients will get either placebo or Itolizumab and they will get up to two doses of either placebo or Itolizumab on Day 1 and Day 8 if necessary.
All the patients will be closely monitored through Day 28 while hospitalized or through post-discharge follow-up. The main purpose of this study is to evaluate the benefits of itolizumab. The trial will also analyze the safety, tolerability, and pharmacokinetics (PK) of itolizumab.