New York-based biopharma Immunic Inc IMUX, which specializes in developing oral therapies for chronic inflammatory and autoimmune disease, said Wednesday that its lead asset IMU-838 has shown pre-clinical activity against SARS-CoV-2 – the virus that causes COVID-19.
IMU-838 inhibited replication of clinical isolates of the new coronavirus in pre-clinical studies, and in cellular assays the asset showed antiviral activity at concentrations well below the dosing regimens studied in ongoing and previous clinical trials, according to Immunic.
Encouraged by the positive results, Immunic said it is preparing a clinical development program of IMU-838 as a potential treatment option for COVID-19 patients, as well as for future viral pandemics.
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"While most such efforts are focused on drugs and vaccines aimed at viral targets, it is particularly important to explore treatment options targeting host cell factors that are able to act with less dependence on the genetic drift of viruses and synergistically to standard-of-care antiviral therapies," Maria Vehreschild, head of infectious diseases at University Hospital Frankfurt, said in a statement.
The company said it plans to initiate a Phase 2 study in patients with moderate COVID-19 disease and clinical symptoms. An adequate drug supply exists to begin clinical testing in COVID-19 very soon, Immunic said.
BioNTech To Start Human Testing of COVID-19 Vaccine In Germany
BioNTech SE – ADR BNTX and Pfizer Inc. PFE said they have secured the approval of the German regulatory agency to commence a Phase 1/2 study of BioNTech's COVID-19 vaccine BNT162.
The companies also said they plan to conduct clinical trials of BNT162 in the U.S., upon regulatory approval, which is expected shortly.
The German trial will study 200 healthy subjects ages 18-55 and will evaluate a dose range of of 1 µg to 100 µg to determine the optimal dose for further studies as well as evaluate the safety and immunogenicity of the vaccine, the companies said.
The companies said they expect to include subjects with a higher risk for a severe COVID-19 infection in the second part of the study.
BioNTech is also collaborating with Fosun Pharma to develop BNT162 in China.
In premarket trading Wednesday:
Immunic shares were trading 28.97% higher at $11.04 at the time of publication Wednesday, while BioNTech shares were up 12.91% at $47.72. Pfizer shares were trading 2.08% higher at $36.35.
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