GeNeuro announced the joint publications in the leading scientific journal "Annals of Neurology" of the results of the collaboration between GeNeuro and the National Institute of Neurological Disorders and Stroke (NINDS). NINDS is part of the National Institutes of Health (NIH) of the United States. The two publications describe the novel pathogenic mechanism of HERV-K in sporadic ALS and confirm the rationale for the therapeutic relevance of GeNeuro's antibody to neutralize this neurotoxic protein.

Annals of Neurology is an official journal of the American Neurological Association. The online publications and their hard copy version in the last issue of the journal (HERV-K envelope in spinal fluid of Amyotrophic Lateral Sclerosis is toxic - Steiner et al, & Antibody response to HML-2 may be protective in Amyotrophic Lateral Sclerosis - Garcia-Montojo et al. - Annals of Neurology) present preclinical data showing that HERV-K/HML-2 Envelope protein (HERV-K ENV) is present in the cerebrospinal fluid (CSF) of sporadic ALS patients, leads to neuronal cell injury and death, and targets a now identified cellular receptor.

The studies also show that the neurotoxic properties of the HERV-K ENV protein from ALS patients' CSF are neutralized by GeNeuro's anti-HERV-K ENV antibody and that, in patients with sporadic ALS, higher levels of autoantibodies targeting the HERV-K ENV protein are associated with a longer survival. As previously mentioned, GeNeuro's preclinical development program has confirmed the ability to detect HERV-K ENV in sporadic ALS patients and has enabled its anti-HERV-K ENV antibody to be humanized and ready to enter GMP production. The published findings now open the way for precision medicine with a biomarker-based clinical approach, administering GeNeuro's neutralizing antibody only to sporadic ALS patients who are positive to the HERV-K ENV protein.

Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, is a rapidly progressing neurodegenerative disorder characterized by the destruction of motor neurons leading to progressive muscle paralysis. About 90% of ALS cases occur in patients with no family history of the disease: these cases are known as sporadic ALS, and occur randomly. In the remaining 10% of patients, the disease affects multiple people in the same family with an inherited genetic cause and is called familial ALS.

ALS affects approximately 50,000 patients worldwide, with about 10,000 new patients per year in the United States and Europe.