2‐hydroxyoleic acid (NFX88) / Neurofix - LARVOL DELTA

Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efficacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury. (PubMed, Spinal Cord) - "NFX88 treatment was found to be highly safe and well tolerated, with the dose of 2.10 g/day being the most effective at causing pain relief. Thus, the promising efficacy of this first-in-class lipid mediator deserves further consideration in future clinical trials."

Journal • P2a data • CNS Disorders • Neuralgia • Orthopedics • Pain

Neurofix Pharma has raised 750,000 euros to develop its clinical milestones (List23) - "Neurofix Pharma continues to expand, including through the conclusion of a 750,000 euro round. The aim is to develop the last two clinical milestones before making the biotech's pioneering medicine to treat neuropathic pain from spinal cord injury, the NFX88, commercialable....Neurofix Pharma will be able to undertake phase IIB/III of its research, which will last for 23 months, and it is anticipated that it will begin during the last four months of 2023."

Financing • New P2/3 trial • Central Neuropathic Pain • CNS Disorders • Neuralgia • Pain

Neurofix seeks investors to launch phase III of its pioneering drug against neuropathic pain [Google translation] (El Español) - "Neurofix from Salamanca has presented this morning in the capital Charro the results of the IIB clinical phase of its pioneering drug NFX88, against neuropathic pain....The company from Salamanca is now in the middle of an investment round to make the leap to phase III, which would mean the approval by the Spanish Medicines Agency of a drug that has already been successfully tested so far in 48 patients with injury core of seven different hospitals....The tests carried out up to now have been satisfactory since all the patients experienced, three months after their treatment with NFX88, a significant improvement in the appeasement of chronic pain that severely impairs the quality of life of these patients."

Financing • P2 data • CNS Disorders • Neuralgia • Pain

Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI (clinicaltrials.gov) - P2a | N=44 | Completed | Sponsor: Neurofix S.L. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain

Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI (clinicaltrials.gov) - P2a; N=44; Active, not recruiting; Sponsor: Neurofix S.L.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain

Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI (clinicaltrials.gov) - P2a; N=48; Recruiting; Sponsor: Neurofix S.L.; Trial completion date: Mar 2021 ➔ Mar 2022; Trial primary completion date: Mar 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Complement-mediated Rare Disorders • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain • Peripheral Neuropathic Pain

Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI (clinicaltrials.gov) - P2a; N=60; Recruiting; Sponsor: Neurofix S.L.; Trial completion date: Apr 2020 ➔ Mar 2021; Trial primary completion date: Apr 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Complement-mediated Rare Disorders • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain • Peripheral Neuropathic Pain

The drug created by a company in Salamanca that treats neuropathic pain in patients with spinal cord injury resumes its trials [Google translation] - "The trials of the NFX88 that are being carried out with the drug that is being developed by the biotechnology company Salamanca of the BME Neurofix Premarket to treat neuropathic pain in patients with spinal cord injury, will be progressively resumed in four Spanish hospitals....The progress of the tests will be carried out following the safety regulations set by the Ministry of Health in the face of the current health crisis."

Trial status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain