First patient enrolled in Ferrer's FNP122 ADORE Phase III clinical trial for Amyotrophic Lateral Sclerosis (ALS) treatment
Barcelona, November 9th, 2021 – Ferrer, an international pharmaceutical company focused on neurological disorders and pulmonary vascular and interstitial lung diseases, has today announced the next major milestone in its mission to develop transformative therapies for Amyotrophic Lateral Sclerosis (ALS) – marked by the first patient enrolled in the ALS Deceleration with ORal Edaravone (ADORE), FNP122 Phase III clinical trial. The trial will enrol about 300 patients across European countries and it will evaluate the efficacy, survival and safety of FNP122 as an oral formulation of edaravone in ALS patients. Edaravone is an antioxidant and free radical scavenger that has been shown to reduce excess oxidative stress and cell death1, playing an important role in the pathology of ALS.
Effective treatment of ALS continues to be a significant unmet need and the start of the ADORE Phase III clinical trial is a meaningful moment for the Ferrer team, which is dedicated to making a positive impact on the lives of patients through the research, development, and commercialization of transformative therapies in neurological disorders.
According to Rodrigo Palma dos Reis, Chief Medical Officer at Ferrer, “ALS has a profound impact on the lives of people diagnosed with the disease, as well as their loved ones. We feel a great sense of purpose and responsibility to develop this potential therapy with the aim of improving the current standard of care.”
Tatjana Naranda, Ferrer’s Chief R&D Officer, added: “Ferrer cares deeply about patients affected by ALS and meeting their needs is the major driving force behind this study. FNP122 is aimed at transforming the lives of patients who suffer from ALS and we have made a strong commitment to deliver therapeutic solutions to patients and their families”.
The ADORE Phase III clinical trial is being conducted with the support of TRICALS, the largest European research initiative to find a cure for ALS. Prof. Leonard H. van den Berg, Chair of TRICALS, Professor of Neurology at the University Medical Centre Utrecht, The Netherlands, and Principal Investigator of the study explained: “The TRICALS consortium is proud to collaborate with Ferrer, since this is an important study, and we look forward to offering further support throughout the course of the trial. We hope oral edaravone will yield a positive outcome and be beneficial for people diagnosed with ALS, as more effective treatment is available”.
This major milestone comes swiftly after Ferrer announced its licence agreement with Treeway – a Dutch clinical-stage biotechnology company founded by ALS patients – for the development and commercialisation of FNP122 for ALS in certain territories, including Europe and some Asian countries.
Amyotrophic lateral sclerosis (ALS), the most frequent motor neuron disease, is a progressive neurodegenerative disease of motor neurons in the brain and spinal cord, resulting in progressive paralysis, with death typically within 2 to 5 years of diagnosis.
ALS is a rare disease with multifactorial etiology, and the precise pathogenic mechanism is still unknown. ALS typically occurs in people between 40-70 years old, slightly more men than women. It is caused by a multitude of factors: 10-15% familiar ALS, 85-90% sporadic ALS.
1 Brotman et al., 2020; Ito et al. 2008
2 Masrori and Van Damme; Amyotrophic lateral sclerosis: a clinical review. European Journal of Neurology 2020, 27: 1918– 1929