Phase I clinical trial successful in healthy volunteers
Over EUR 6 million raised for the Phase II clinical trial – expected to begin in 1H 2024
Vienna, Austria, 25 January 2024 – G.ST Antivirals, a clinical-stage biotechnology company applying innovative, host cell-based strategies to develop broad-spectrum antivirals against respiratory tract infections, today reported positive results from its Phase I clinical trial evaluating its lead programme, a nasal spray containing 2-Deoxy-D-glucose (2-DG). The compound tackles rhinoviruses (RVs), the causative agent of the common cold and more severe respiratory diseases in vulnerable individuals, and other important agents such as coronaviruses. In addition, the company announced that it has secured financing for the follow-up Phase II clinical trial, which is set to start in the first half of 2024. Results of the Phase I trial demonstrated that an intranasal administration of 2-DG is safe, well tolerated and does not lead to any serious adverse events (SAEs).
Alongside these clinical results, the company has raised funds totalling over EUR 6 million to complete the Phase II clinical trial. The funds comprise a EUR 4 million Series A round led by xista science ventures (xsv) with participation from the Lansdowne Investment Company, an investment vehicle managed by Lansdowne Partners Austria GmbH, as well as a funding commitment of EUR 2.2 million from the Life Sciences Programme of the Austrian Research Promotion Agency (FFG).
“The results of the Phase I trial confirm the safety of our innovative approach of using 2-DG to treat respiratory infections. This could be a doorway to improve the lives for millions of patients, especially vulnerable individuals, school children, parents and teachers,” said Dr. Anna-Dorothea Gorki, CSO of G.ST Antivirals. “By targeting the host cell, we remove the likelihood of drug resistance development, and also ensure broad applicability, based on a safe, tolerable treatment, potentially delivering savings to healthcare industries and national economies,” she added.
G.ST Antivirals has developed a highly innovative, patented medication against RVs and other respiratory pathogens. This approach is based on manipulating the metabolism of the host cell. Viruses do not possess a metabolism of their own and are dependent on the host cell to multiply. Infections with RVs in particular lead to an anabolic state of the infected cells. This upregulation of host cell metabolic pathways, such as glycolysis, allows the virus to rapidly multiply. Inhibition of glycolysis by the glucose analogue 2-DG reverses the virus-induced metabolic reprogramming of host cells and prevents the utilization of sugar by the virus, thereby significantly limiting its reproduction and consequently starving the virus.
“While viral infections of the upper respiratory tract are ubiquitous, they are currently insufficiently treated, and RVs are responsible for most of these infections. The results from our Phase I study give us great confidence in the future of 2-DG and our company,” said Dr. Guido Gualdoni, Co-Founder and CEO of G.ST Antivirals. “The years of in-house development have convinced us of the great potential of our approach, which is also backed by investor vision through our Series A financing and the funding commitment from the FFG,” he noted.
In the randomized, double-blind, placebo-controlled study conducted at the Vienna General Hospital, 45 healthy volunteers received either a single ascending dose (SAD) or multiple ascending doses (MAD), of 3.5% 2-DG as nasal spray solution or placebo. A total of 36 study participants were treated with 2-DG and 9 participants were treated with placebo. Safety, tolerability and olfactory function as well as the pharmacokinetics of 2-DG were assessed. A total of 11 adverse events (AEs) were reported by study participants, and there were no differences found in the rate of AEs between 2-DG-treated and placebo-treated groups. Intranasal administration of 2-DG did not lead to any safety observations or SAEs, changes in olfactory function or changes in blood glucose levels.
About G.ST Antivirals
G.ST Antivirals is an Austrian company founded in 2019 as a spin-off from the Medical University of Vienna. Following extensive research on the inhibition of rhinovirus infections, G.ST Antivirals has developed a patented, innovative drug against colds and other viral infections. For this discovery, the two founders Guido Gualdoni, CEO, and Johannes Stöckl, who is part of the company’s advisory board, received the award “Inventor of the Year” by the Medical University of Vienna in 2020. After a successful funding round in 2020, the start of a Phase 1 clinical trial at the Department of Clinical Pharmacology followed in 2022.
Guido Gualdoni, MD, PhD
Chief Executive Officer
G.ST Antivirals GmbH
Dr. Bohr-Gasse 7
MC Services AG
Dr. Cora Kaiser, Dr. Johanna Kobler
+49 89 210 228 0