- Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the “dark genome” of all people.
- K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the neurodegenerative findings of ALS in experimental animals and human neuron cells.
- The patent (EP 3 570 878 B1) covers a novel monoclonal antibody (GNK-301) developed by GeNeuro and scientists at the US National Institute of Neurological Disorders and Stroke (NINDS) under a Cooperative Research and Development Agreement and co-owned under a subsequent patent agreement. Two US patents (10,723,787 and 10,981,977) have previously been granted for this invention.
- As described in the patents, GNK-301 has been shown to prevent the neurotoxic effects of K Env in nonclinical subjects and in human motor neuron cells – the cells that are damaged by ALS.
- GeNeuro has instituted GMP manufacture of GNK-301 and anticipates initiating human Phase I trials in patients with ALS in the second half of 2027 in the US and Europe.
- GeNeuro was selected in the first round of the Congressionally Directed Medical Research Program for two potential awards and is finalizing its submission.
- GeNeuro will participate in a conference this weekend on “HERVs and Humanity” bringing together leading clinicians and molecular biologists to focus on the understanding and treatment of HERV-induced diseases, including ALS, Multiple Sclerosis, Optic Neuritis, and Schizophrenia.
MIAMI, Sept. 14, 2026 (GLOBE NEWSWIRE) -- GeNeuro, Inc., (“GeNeuro” or the “Company”), a subsidiary of NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), today announced the award of a European Patent (EP 3 570 878 B1) entitled “Anti HERV K Envelope Antibody and Uses Thereof.” The patent, together with two previously-issued US patents (10,723,787 and 10,981,977) describes in detail the discovery that the envelope protein (K Env) of Human Endogenous Retrovirus K (HERV K) is found in the spinal fluid of more than 75% of people with Amyotrophic Lateral Sclerosis (ALS), is shown to be highly neurotoxic, and to produce the neurodegenerative findings of ALS in laboratory animals and in human motor neuron cell culture.
HERVs are the remnants of viruses that infected primates between 2 and 5 million years ago and are now thought to have played a role in human disease. A monoclonal antibody against K Env (GNK-301) has been shown to block those neurotoxic effects in the same models. The discovery was made by a team comprised of scientists from Geneuro SA (Lyon, France) and the US National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health (NIH) under a Cooperative Research and Development Agreement (CRADA) and subsequent patent agreement. The patents are jointly owned by GeNeuro and the US Dept. of Health and Human Services.
The assets of the former Geneuro SA were awarded to GeNeuro, Inc. (Miami, FL) by the Courts of Switzerland in June 2026 and GeNeuro initiated manufacture of GNK-301 under Good Manufacturing Practices (cGMP) with the plan to initiate human Phase 1 trials of GNK-301 in the US and Europe in the latter half of 2027.
Geneuro SA previously conducted five human trials of a related antibody (Temelimab®) which targets the envelope protein of HERV W in more than 400 human participants who had Multiple Sclerosis, Type 1 Diabetes, or symptoms of Long Covid, with no Serious Adverse Events. Temelimab was shown to cross the blood brain barrier and to achieve a statistically significant reduction in neurodegeneration, as measured by “Black Holes” on Magnetic Resonance Imaging (MRI) and a corresponding reduction in brain shrinkage. The Company believes these results support the potential for anti-HERV Envelope antibodies to achieve clinically meaningful effects in patients with HERV-mediated neurodegenerative diseases.
The recently-issued patent adds to a portfolio of more than 25 issued and pending patents owned by GeNeuro related to the effects of HERVs and to methods of diagnosing and mitigating those effects. A more comprehensive list can be found on www.geneuro.us.
In August 2026, GeNeuro, in partnership with NINDS was selected in the first round of the ALS grant competition of the Congressionally Directed Medical Research Program (CDMRP) for potential awards in Therapeutic Development and Biomarker Development and is currently preparing its final bid submission. This weekend, the first annual conference on “HERVs and Humanity” will be held at the Princeton Institute for Advanced Study to bring together an international group of clinicians and molecular biologists to prioritize research objectives and clinical priorities in this dramatic new area of science. Portions of the conference will be simulcast.
“ALS is possibly the most devastating diseases one can contract, with a life expectancy of two to five years. The opportunity to partner with the NIH and leading experts across the globe around a biomarker-targeted, potentially disease-modifying drug has the potential to forever change the course of this terrible disease,” said Dr. Jonathan Javitt, the Company’s CEO.
About GeNeuro, Inc.
GeNeuro, Inc. (www.geneuro.us) is a newly-formed US Company organized around the assets of the former Geneuro SA. Those assets include the products of more than $180 million in funded research on Human Endogenous Retrovirus-targeted drugs for ALS, Multiple Sclerosis, Type 1 Diabetes, and Schizophrenia. Temelimab, targeting the HERV W Envelope protein has reached Phase 2 in Europe with completed clinical trials demonstrating statistically-significant reductions in neurodegeneration in multiple sclerosis and decreased Islet cell destruction in Type 1 diabetes. GNK-301, targeting ALS was developed and patented worldwide under a Cooperative Research and Development Agreement with the US National Institutes of Health and is now in production and anticipated to enter Phase 1 human trials in the second half of 2026.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in NRx Pharmaceuticals, Inc.'s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
For further information:
Brian KorbMatthew DuffyManaging Partner, astr partnersChief Business Officer(917) 653-5122+1 (646) [email protected]@geneuro.us