Barcelona, November 9, 2021 – Ferrer, an international pharmaceutical laboratory focused on neurological disorders and vascular and interstitial lung diseases, today announces the inclusion of the first patient in the phase III clinical trial, ADORE (ALS Deceleration with ORal Edaravone), of FNP122 in amyotrophic lateral sclerosis (ALS). The achievement of this milestone is part of Ferrer's mission to develop transformative therapies for this pathology.
The clinical trial is expected to include 300 ALS patients from various European countries. The aim is to evaluate the efficacy and safety of the oral formulation of edaravone (FNP122), as well as the increased survival of patients with this disease. The molecule acts as a free radical-reducing antioxidant, which protects nerve cells from oxidative stress and decreases cell death1, playing a significant role in the treatment of ALS.
Effective treatment for this disease remains an unmet clinical need. The start of ADORE is a very important achievement for Ferrer's team, whose objective is to generate a positive impact on the lives of patients through research into transformative therapies in the field of neurological disorders.
According to Rodrigo Palma dos Reis, Chief Medical Officer of Ferrer, "ALS has very serious effects on the lives of patients diagnosed with the disease and on the lives of their loved ones. At Ferrer, we feel a great responsibility to develop this new treatment with the aim of improving the options currently available".
Tatjana Naranda, Chief R&D Officer at Ferrer, adds: "Ferrer cares about patients affected by ALS and their families. By conducting this clinical trial, we show our firm commitment to providing therapeutic solutions for this disease. FNP122 aims to respond to the unmet clinical needs of people suffering from ALS and thus help improve their day-to-day lives."
The Phase III clinical trial, ADORE, is being conducted with the support of TRICALS, Europe's largest research initiative to find a cure for ALS. Professor Leonard H. van den Berg, President of TRICALS, Professor of Neurology at University Medical Center Utrecht, The Netherlands, and Principal Investigator of the clinical trial, states: "The TRICALS consortium is proud to collaborate with Ferrer on this important clinical trial and we look forward to continuing to offer our support throughout the course of the study. We hope that Ferrer's oral formulation of edaravone will obtain positive results and be an effective and beneficial treatment for those diagnosed with ALS."
This important milestone follows the licensing agreement between Ferrer and Treeway – a Dutch biotechnology company founded by ALS patients.
About ELA2
Amyotrophic Lateral Sclerosis (ALS), the most common neuromotor disease, is a neurodegenerative disorder of the motor neurons of the brain and spinal cord, progressively causing paralysis, until death, usually 2 to 5 years after diagnosis.
ALS is a rare disease with a multifactorial etiology whose pathogenic mechanism is not yet precisely understood. ALS typically appears in people between 40 and 70 years of age, being more frequent in men than in women, and a distinction is made between two types: familial ALS, which affects 10-15% of patients, and sporadic ALS, which affects 85-90% of them.
References:
- Brotman et al., 2020; Ito et al. 2008
- Masrori and Van Damme; Amyotrophic lateral sclerosis: a clinical review. European Journal of Neurology 2020, 27: 1918–1929
