New dosage regimen for inhaled vasoactive intestinal polypeptide

#The present invention relates to new dosage regimen of aviptadil for use in the treatment of lung diseases.

#Since VIP agonists have potent bronchodilator and immunomodulatory effects in the respiratory system, their use has been suggested for asthma, pulmonary hypertension, chronic obstructive pulmonary disease, sarcoidosis, and COVID-19, as well as inflammatory upper respiratory tract diseases.

#Inhaled VIP agonists show localized effects. Therefore, systemic side effects are expected to be less. (Mathioudakis, Chatzimavridou-Grigoriadou et al. 2013). Different inhalation dosages were evaluated. A single 375 μg inhaled VIP was briefly evaluated for protection against histamine-induced bronchoconstriction. Although the effectiveness of inhaled VIP was known, the activity could not be shown in this study. This lack of effectiveness of aerosolized VIP were explained by rapid metabolic inactivation or from avid binding to mucus layer proteins. Therefore no side effects were reported (Altiere, Kung et al. 1984). In another study, subjects received 100 μg VIP agonists as a single dose for determining the effect of inhaled VIP agonists on bronchial reactivity to histamine in humans (Barnes and Dixon 1984). For determination of the effect of VIP agonists on propranolol-induced bronchoconstriction, VIP was used as a single 70 μg dose inhalation in clinical tests (Crimi, Palermo et al. 1988).

#The present invention provides a method of treating a lung disease in a subject in need thereof by administering of an effective dose of aviptadil to the subject.

#In one embodiment, the present invention provides aviptadil for use in the treatment of a lung disease in a subject in need thereof wherein said composition is administered at least 2 times in a day, preferably 2 times in a day compared to the prior art administration regimes. Thus, the virus transmission is decreased by reducing the dosing frequency instead of giving aviptadil by nebulization 3 times a day. The inventors aim to protect both patient relatives and healthcare workers especially in pandemic conditions such as Covid-19.

#According to the present invention, aviptadil for use in the treatment of a lung disease in a subject in need thereof is administered at least 2 times in a day, preferably 2 times in a day, wherein the period between the administrations does not exceed 200 minutes or preferably the period between the administrations is from 5 to 120 minutes; more preferably from 15 to 110 minutes, from 20 to 100 minutes, from 25 to 90 minutes or from 15 to 90 minutes and most preferably 30 minutes. It has been surprisingly found that by significantly reducing the period between the administrations of aviptadil it is possible to provide a treatment while reducing the spread of virus and to increase the patient compliance without any side effects.