RE: French Extavia trial result expected this month5 Jun 2021 08:14
Fact :-
The only complete, currently available Treatment Emergent Adverse Events (TEAE) study with IFN-ß inhalation comes from Synairgen, a drug discovery and development company founded by the University of Southampton, United Kingdom who developed SNG001, an aerosolizable form of IFN-ß-1a. SNG001 has been used in phase 1 and 2 clinical trials with the aim to reduce rhinovirus-related symptoms in asthma patients. The drug allowed limited use of corticosteroids and presented few side effects (limited to 6.9% heart palpitations) (Djukanovic et al., 2014). Moreover, no fever was observed although it was found in almost half of the patients when the product was administered subcutaneously (Limmroth et al., 2011). Psychiatric side effects were limited to rare sleep disturbances, and there was no significant hematological or hepatic toxicity, consistent with poor systemic passage of IFN aerosols (Djukanovic et al., 2014). In view of this favorable risk/benefit balance, we decided to develop a nebulization protocol for IFN-ß-1b administration. We present here the methods of IFN-ß-1b administration, and the results obtained in four patients after administration on a compassionate basis.