Ferrer Initiates its ADOREXT Extension Study in Amyotrophic Lateral Sclerosis (ALS)

(BUSINESS WIRE)--The international pharmaceutical company Ferrer has announced the extension of its 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. All participants will remain in active treatment.

The extension will allow further evaluation of the long-term safety 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 and safety 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 its 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.

References:

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

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