NeuroSense Therapeutics Ltd nhasi yazivisa kuti yawana mvumo kubva kuUS Food and Drug Administration (FDA) kuti itange chidzidzo che pharmacokinetic chePrimeC muzvidzidzo zvevakuru vane hutano. PrimeC ibhuku rakawedzerwa-kuburitswa remuromo kuumbwa rinoumbwa rakasiyana-siyana-dose musanganiswa wemishonga miviri yakatenderwa neFDA: ciprofloxacin uye celecoxib. PrimeC yakagadzirirwa kubatanidza nzira dzakati wandei dzeamyotrophic lateral sclerosis (ALS) iyo inobatsira mukuderera kwemota neuron, kuzvimba, kuunganidzwa kwesimbi uye kukanganisa RNA mutemo kuti uvhare kufambira mberi kweALS.
PrimeC yakapihwa Orphan Drug Designation neFDA neEuropean Medicines Agency (EMA). NeuroSense yakapedza chidzidzo chekiriniki chePhase IIa icho chakabudirira kusangana nekuchengetedza kwayo uye magumo ekupedzisira anosanganisira kudzikisira kushanda uye kufema kuderera uye shanduko dzakakosha mune ALS-ane chekuita nebiological mamaki anoratidza chiitiko chePrimeC. Iyo Kambani inoronga kutanga Phase IIb yakapetwa kaviri-mapofu placebo-inodzorwa nyika dzakawanda kudzidza muQ2 2022 ine yakagadziridzwa dosi uye yakasarudzika yakakwidziridzwa maumbirwo.
Iyo pharmacokinetic yekudzidza (NCT05232461) iPhase I yakavhurika-label, randomized, single-dose, matatu kurapwa, matatu-nguva crossover kudzidza kuongorora mhedzisiro yechikafu pabioavailability yePrimeC kana ichienzaniswa neiyo bioavailability yeco-administered ciprofloxacin mapiritsi. uye celecoxib capsules mune gumi nemaviri evakuru vane hutano zvidzidzo muUS.
"Data kubva kuChidzidzo chedu chekiriniki chePhase IIa chakasimbisa kuti PrimeC inyanzvi yekurapa ine mukana wekubatsira vanhu vane ALS uye kugadzirisa misika yemadhora mabhiriyoni matatu inoda kurapwa kunoshanda," akadaro NeuroSense CEO Alon Ben-Noon. "Patinogadzirira kutanga chidzidzo chedu chePhase IIb mumwedzi mishoma iri kutevera, chinangwa chekudzidza kwedu kwemishonga pasi peFDA IND ndechekugadzira imwe data pamusoro pekuwanikwa kwePrimeC maererano nekudyiwa kwechikafu muvanhu vane hutano. Takazvipira zvikuru kuvandudza hupenyu hwevanhu vane ALS uye tinodada nekugadzira mushonga mutsva unogona kugadzirisa chirwere ichi chakaoma. "
NeuroSense nguva pfupi yadarika yakazivisa nhanho yechitatu yekubatana kwayo neMassachusetts General Hospital muBoston pane novel Neuron-Derived Exosomes (NDEs) kuti ienderere mberi nekuona shanduko yebiological muALS-ane hukama pathologies uye mhedzisiro yePrimeC pane yakakodzera zvinangwa. Mibairo kubva muchidzidzo ichi inotarisirwa Q2 2022.
NeuroSense zvakare iri kusimudzira zvirongwa muchirwere cheAlzheimer chemumiriri wezvinodhaka CogniC uye chirwere cheParkinson cheStabiliC. Dhata kubva kuzvidzidzo zvepreclinical zvinotarisirwa H2 2022, uye zvichitevera kutumirwa kweIND kuFDA, NeuroSense inotarisira kutanga zvidzidzo zvekiriniki mune izvi zviratidzo muH1 2023.
ZVOKUBVA MUNYAYA INO:
- Iyo pharmacokinetic yekudzidza (NCT05232461) iPhase I yakavhurika-label, randomized, single-dose, matatu kurapwa, matatu-nguva crossover kudzidza kuongorora mhedzisiro yechikafu pabioavailability yePrimeC kana ichienzaniswa neiyo bioavailability yeco-administered ciprofloxacin mapiritsi. uye celecoxib capsules mune gumi nemaviri evakuru vane hutano zvidzidzo muUS.
- “As we prepare to initiate our Phase IIb study in the next few months, the goal of our pharmacokinetic study under FDA IND is to generate additional data on the bioavailability of PrimeC as it relates to food intake in healthy individuals.
- “Data from our Phase IIa clinical study confirmed that PrimeC is a novel therapy with the potential to help people with ALS and address a $3 billion market in need of a more effective treatment,”.
