Spinal cord injuries (SCI), usually a result from trauma, disease or degeneration, lead to a wide range of health complications depending on the severity of the injury and its location on the spinal cord.
One such complication is neuropathic pain, a type of chronic pain that is initiated or caused by a primary lesion or dysfunction of the nervous system. In patients with SCI, NP arises within the first few months after injury, is progressive for about 3-5 years before reaching a plateau and may persist for many years after the acute injury. Neuropathic pain has a substantial negative impact on patient function and quality of life and 17% of patients have health-related quality of life scores equivalent to “worse than death”.
Current treatments options are inadequate, commonly resulting in a reduction of only 20-30% in pain intensity and have significant side effects.
Our product NFX88 (2‐hydroxyoleic acid) is a derivative of oleic acid that is incorporated into, and modulates de composition of, cell membranes, leading to changes in downstream signalling pathways and in gene expression.
In a rat model of spinal cord injury, treatment with NFX88 led to a significant increase in the expression of 20 genes; and a significant decrease in the expression of 21 genes. Amongst the upregulated transcripts were genes involved in neuronal survival, morphogenesis and growth, whereas downregulated transcripts included genes that encode for lipid mediators of inflammation (Ávila- Martin, 2017 PLoS ONE).
Furthermore, in a rat model of Spared Nerve Injury, NFX88 had an antinociceptive effect on the duration of the withdrawal reflex evoked by pin-prick stimulation or cold stimuli applied as an acetone drop (Ávila-Martin, 2014 Eur Journal Pain).
NFX88 has already been shown to be well-tolerated in patients (NCT01792310) and Neurofix has now initiated a randomized, double blind, placebo-controlled Phase 2a study in complete or incomplete spinal cord injury patients with neuropathic pain.
The aim of the study is to evaluate safety and tolerability of NFX88 treatment, as well as its therapeutic efficacy through the analysis of validated pain measurement scales.
The study will be carried out in six hospitals in Spain, and the leading investigators are:
Dr. Antonio Oliviero
National Paraplegic Hospital (Toledo)
Dr. Sebastián Salvador
A Coruña University Hospital
Dra. Judith Sánchez
Vall d’Hebron University Hospital (Barcelona)
Dr. Miguel D. Membrilla
Virgen de las Nieves University Hospital (Granada)
Dr. Joan Vidal
Institut Guttmann (Barcelona)
Dra. Natacha León
Los Madroños Hospital (Brunete – Madrid)