Orpheris launches phase II trial for COVID-19 immunotherapy

By The Science Advisory Board staff writers

September 1, 2020 -- Orpheris said that the first patients have been enrolled in a phase II trial to assess its OP-101 compound for treating hospitalized adults with severe COVID-19.

The study will be led by investigators at academic medical centers such as Johns Hopkins Hospital, Emory University, Loma Linda University Health, and the University of Texas Health Science Center at Houston. Invented at Johns Hopkins University, OP-101, a compound created by the conjugation of N-acetyl cysteine to a hydroxyl dendrimer, selectively targets immune cells responsible for hyperinflammation in patients with severe COVID-19, Orpheris said.

The study, called OP-101 to Arrest Hyperinflammation in COVID-19 Patients (PRANA), is a randomized, double-blind, placebo-controlled phase II clinical study that will enroll approximately 24 patients. The primary endpoint will be safety and tolerability; secondary endpoints including efficacy as measured by: resolution of fever, improvement in oxygenation, discharge from clinic or hospital, number of days free from a ventilator, number of days in the intensive care unit, hospitalizations and deaths, among other measures. It will also evaluate the effect of OP-101 in reducing blood levels of c-reactive protein, ferritin, and interleukin-6 after a single dose of OP-101.

Orpheris said it expects to receive initial data from the phase II proof-of-concept study in the fourth quarter of 2020. The company has also discussed an expansion of the study into a double-blind, placebo-controlled COVID-19 trial with the U.S. Food and Drug Administration. That study is expected to include up to 20 sites after the results from the ongoing stage are evaluated, according to the firm.

Study investigates pharmacogenomics of COVID-19 therapies
Human genetic variation may alter the interactions of drugs being used to treat patients with COVID-19 symptoms, resulting in a range of clinical responses...
Gateway receptor for SARS-CoV-2 helps explain variability of COVID-19
A wide variety of symptoms and organs are involved in SARS-CoV-2 infection. This phenomenon could be explained by the distribution of the virus's gateway...
Irisys to manufacture Qualigen COVID-19 drug
Qualigen Therapeutics has signed a contract with Irisys for the production of AS1411, Qualigen's lead candidate for the treatment of viral diseases including...
New mouse-adapted model helps accelerate COVID-19 vaccines, therapies
A new mouse-adapted SARS-CoV-2 model developed with engineered virus can help accelerate vaccine and therapeutic candidates to clinical trials. The results...
Thermo Fisher opens manufacturing site for COVID-19 viral transport media
Thermo Fisher Scientific has opened its new $40 million facility in Lenexa, KS, dedicated to viral transport media production. The groundbreaking...

Copyright © 2020 scienceboard.net


Conferences
Building Biology in 3D Hybrid Symposium
October 26-27
La Jolla, California United States
Northeast Regional Laboratory Staff and Core Directors (NERLSCD) 2021
November 3-5
Portsmouth, New Hampshire United States
CPhI Worldwide 2021
November 9-11
Milan, Lombardia Italy
Society for Immunotherapy of Cancer (SITC) Annual Meeting
November 10-14
Washington, DC, District of Columbia United States
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter