Repurposed autoimmune therapies head for controlled COVID-19 studies in Europe
Plus USPTO to fast-track patent reviews, and a social distancing tool for the lab and office
Abivax and Immunic are launching COVID-19 trials of their autoimmune therapies in France and Germany, respectively, meeting regulators’ demands for large, controlled studies to demonstrate therapeutic efficacy. In the U.S., the patent office is fast-tracking coronavirus-related applications, and Obsidian is rolling out a free program for biopharmas to more easily social distance while continuing lab work.
There are at least 80 immunosuppressants in the clinic and at least 33 antivirals, according to BioCentury’s COVID-19 Resource Center.
Shares of Abivax S.A. (Euronext:ABVX) rose €3.88 (23%) to €21 on Thursday when it announced France has cleared the start of a randomized, double-blind, placebo-controlled Phase IIb/III trial of ABX464, an oral small molecule in Phase IIb testing for ulcerative colitis.
The trial will enroll 1,034 high-risk adult COVID-19 patients -- either over age 65 or with risk factors -- in 50 hospitals across France and elsewhere in Europe.
The study, which will complete patient enrollment within a few months, will evaluate patient use of high-flow oxygen or assisted ventilation, or mortality, after 28 days.
Abivax said it has enough ABX464 capsules to treat about 50,000 patients, and that within months, it can scale up its manufacturing capacity to provide for 1 million patients.
ABX464 has antiviral, anti-inflammatory and tissue-reparative properties, Abivax said. The compound, which was initially developed for HIV, blocks viral replication by binding CBC. ABX464 also upregulates miR-124, which in turn downregulates inflammatory cytokines.
In a reconstituted human respiratory epithelium model in vitro, ABX464 inhibited SARS-CoV-2, the company said.
Also exploring the use of a ulcerative colitis therapy for COVID-19 is Immunic Inc. (NASDAQ:IMUX). The company received clearance Wednesday by Germany to start an adaptive Phase II trial of IMU-838, a selective oral DHODH inhibitor.
Immunic expects to dose the first patient this month, with top-line data available by year-end.
The randomized, placebo-controlled CALVID-1 trial will enroll about 230 patients with moderate COVID-19 at 10-35 centers across Europe and the U.S.
If clinical activity is confirmed by an IDMC after the first interim analysis, the trial can be expanded into Phase III testing. The study’s primary endpoint is the proportion of patients free of invasive ventilation at day 28; the first analysis will occur after 200 patients have received a blinded treatment.
IMU-838, which is in Phase II testing in ulcerative colitis and multiple sclerosis, inhibited replication of SARS-CoV-2 in cellular assays, Immunic said.
Immunic added $0.60 to $10.78 Thursday.
A speedier USPTO
To speed up the assessment of COVID-19 related patents, the U.S. Patent and Trademark Office rolled out a COVID-19 Prioritized Examination Pilot Program last week.
The pilot will grant prioritized examinations to applications covering a product or process that is subject to FDA approval to prevent or treat COVID-19, with the goal of finishing evaluations within six months.
USPTO will also waive application fees for applicants that qualify for small- or micro- entity status.
Social distancing tool
Obsidian Therapeutics Inc. said this month it will making its web-based application, the Safe Workplace Function Tool (SWFT) Productivity Solution, freely available. The program is intended to ensure social distancing in the lab and office to allow companies to continue to generate data during the pandemic.
The tool allows scientists to view, schedule and adjust lab-based activities based on the program’s ability to predict scheduling and occupancy conflicts.
Bristol Myers Squibb Co. (NYSE:BMY), who is partnered with Obsidian on its engineered protein platform, has already implemented the tool at its Seattle site (see “Fine-Tuning Therapeutic Protein Expression”).
CBC - Cap binding complex
DHODH - Dihydroorotate dehydrogenase
miR-124 - MicroRNA-124