Press release
Arcturus Therapeutics Presents New Clinical Data at 47th Annual European Cystic Fibrosis Conference
ARCT-032 is safe and well tolerated with no serious adverse events (SAEs) in 36 study participants, including 4 adults with cystic fibrosis (CF) Phase 1b
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nARCT-032 is safe and well tolerated with no serious adverse events (SAEs) in 36 study participants, including 4 adults with cystic fibrosis (CF)\n\n\nPhase 1b interim data includes a CF participant with Class 1 mutations and three participants with F508del mutations being treated with Trikafta®\n\n\nEarly trend of improved lung function with an average absolute response of +4.0% (ranging up to +9%) and relative change of +5.8% FEV1 on Day 8, after two doses of ARCT-032\n\n\nClinical data is consistent with pre-clinical CF ferret model data\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to treat unmet medical needs within liver and respiratory rare diseases, today presented Phase 1 results in healthy volunteers and Phase 1b interim data in people with CF for ARCT-032, an inhaled investigational mRNA therapeutic, at the 47th European Cystic Fibrosis Conference in Glasgow, Scotland.\n\n\nARCT-032 administration was generally safe and well tolerated with no serious or severe adverse events in healthy volunteers and the first four dosed participants with CF. The Phase 1b trial showed improvements in FEV1 (Forced Expiratory Volume in 1 second) in the four adults with CF after two inhaled administrations. The absolute change in percent predicted FEV1 averaged +4.0% on Day 8 (5 days after 2nd dose). The relative change in FEV1 averaged +5.8% on Day 8. The observed increases in FEV1 are encouraging and consistent with the previously reported data in the CF ferret model that demonstrated markedly improved mucociliary clearance (MCC) after a single dose of ARCT-032. Of the four participants in Phase 1b to date, one had 2 Class I mutations and the other three had F508del mutations and were being treated with Trikafta®.\n\n\nPhase 1b Interim ppFEV1* Data\n\n\n\n\nSubject #\n\n\n\n\n\n\nAge\n\n\n\n\n\n\nSex\n\n\n\n\n\n\nGenotype\n\n\n\n\n\n\nOn Trikafta®\n\n\n\n\n\n\nBaseline ppFEV1\n\n\n\n\n\n\nDay 8 ppFEV1\n\n\n\n\n\n\n\n\n1\n\n\n\n\n\n\n24\n\n\n\n\n\n\nF\n\n\n\n\n\n\nF508\n\n\n\n\n\n\nYes\n\n\n\n\n\n\n83%\n\n\n\n\n\n\n85%\n\n\n\n\n\n\n\n\n2\n\n\n\n\n\n\n43\n\n\n\n\n\n\nM\n\n\n\n\n\n\nF508/G85E\n\n\n\n\n\n\nYes\n\n\n\n\n\n\n72%\n\n\n\n\n\n\n81%\n\n\n\n\n\n\n\n\...