We extend our clinical study in amyotrophic lateral sclerosis (ALS)
Barcelona, June 21st - With the aim of making a positive impact in society, we have started the extension of our phase III clinical trial ADORE (ALS trial with Daily ORal Edaravone), with FNP122 in amyotrophic lateral sclerosis (ALS). The ADOREXT study offers the possibility of receiving FNP-122 to all ADORE participants that complete the full study period. Patients who stopped treatment (for other than safety reasons) but completed the study period will be also invited to participate in ADOREXT.
The extension will allow further evaluation of the long-term efficacy of the daily oral formulation of edaravone (FNP122) for patients with ALS, a disease for which treatment is still an unmet need. Since its inception, the ADORE study has aimed to evaluate the efficacy of edaravone (FNP122), in addition to establishing its ability to prolong the survival of people living with this disease. The molecule acts as an antioxidant with the potential to delay disease progression by protecting nerve cells1.
As Tatjana Naranda, Ferrer's Chief R&D Officer, explains "the ADOREXT study allows the company's research team to continue in its aim to bring significant and differential value to people suffering from serious diseases such as ALS. At Ferrer, we have the commitment and vocation to transform the lives of people living with serious and debilitating diseases.”
International European study with the support of TRICALS
The extension of the Phase III clinical trial, ADORE, will continue to be supported by TRICALS, Europe's largest initiative researching a cure for ALS. Currently, a number of patients from Spain, France, Italy, Belgium, Germany, the Netherlands, Poland, Ireland and Sweden have been included. It is expected that participants from additional countries will be enrolled in the coming months.
The ADOREXT protocol has been developed considering ALS patients’ (pALS) needs and perspectives collected in an ALS Patient Representatives Advisory Board (PAB) in which 8 patient organizations from Europe and North America participated.
In line with our growing focus in neurological disorders, together with pulmonary vascular and interstitial diseases, Ferrer initiated the ADORE clinical trial in November 2021. The roll over from the ADORE study to the ADOREXT study started in March 2023.
Amyotrophic lateral sclerosis (ALS), the most frequent motor neuron disease, is a progressive neurodegenerative disease of 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 aged between 40-70 years old, with slightly more men than women affected. There are two types: familial ALS, accounting for 10-15% of patients, and sporadic ALS, which affects 85-90%.
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