Barcelona, June 21 - With the aim of continuing to generate a positive impact on society, we are extending our phase III clinical trial, ADORE (ALS trial with Daily ORal Edaravone), with FNP122 in amyotrophic lateral sclerosis (ALS). This temporary extension will allow participants who completed the original study period, as well as those who discontinued their participation for any reason unrelated to safety, to be included in a new open label extension. All of them will be able to continue in active treatment.
The extension will also allow for further evaluation of the long-term safety of the oral formulation of edaravone (FNP122) for patients with ALS, a condition whose treatment remains an unmet need. Since its inception, the ADORE study has been aimed at evaluating the efficacy of edaravone (FNP122), as well as the prolongation of survival in people living with this disease. The molecule under test acts as an antioxidant with the potential to slow disease progression by protecting nerve cells1.
As Tatjana Naranda, Chief R&D Officer of Ferrer, explained , "the ADOREXT study allows the company's research team to continue persevering in its purpose of providing significant and differential value to people suffering from serious ailments 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 supported by TRICALS
The extension of the Phase III clinical trial, ADORE, will continue to be supported by TRICALS, Europe's largest research initiative to find a cure for ALS. For the moment, several patients from Spain, France, Italy, Belgium, Germany, the Netherlands, Poland, Ireland and Sweden have been included, although it is expected that participants from more countries may enter in the coming months.
The ADOREXT protocol has been developed taking into account the needs and perspectives of ALS patients (pALS) collected in an ALS Patient Representative Advisory Council (PAB) involving 8 patient organizations from Europe and North America.
In line with our growing focus on neurological disorders, along with vascular and interstitial lung diseases, we initiated the ADORE clinical trial in November 2021. The transition from the ADORE study to the ADOREXT study began in March 2023.
About ALS2
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
