Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

Research into VIP’s mechanisms of action is a relic of an older era in biology, when researchers focused on cellular pathways and genomics was not yet a word. Although VIP was once viewed as a promising drug and substantial resources were invested in elucidating its pharmacokinetics, toxicology, and safety pharmacology, pharmaceutical companies found it challenging to administer, given the need for inhaled or IV administration and challenging to formulate. Pulmonary drugs are notoriously difficult to develop, given regulatory requirements for long-term inhaled toxicology studies in multiple species, including primates (Tepper 2016). FDA has asserted that these preclinical toxicology requirements must be observed in the case of candidate drugs to treat COVID-19. VIP, on the other hand, completed four-species toxicology and safety pharmacology studies in both intravenous and inhaled dosage forms but did not proceed to the market for lack of a compelling clinical target. Phase 2 trials in sarcoidosis (Prasse 2010), pulmonary hypertension (Leuchte 2008), pulmonary fibrosis, and allergy/asthma suggest that VIP has no major toxicities when inhaled at doses of 300µg/day and that the toxic dose is at least 25x higher.

https://www.authorea.com/users/321659/articles/450881-perspective-the-potential-role-of-vasoactive-intestinal-peptide-in-treating-covid-19