Ho Hlakola Thuto e Ncha ea Phekolo ea ALS

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Kajeno NeuroSense Therapeutics Ltd e phatlalalitse hore e fumane tumello ho tsoa ho US Food and Drug Administration (FDA) ho qala thuto ea pharmacokinetic ea PrimeC ho batho ba baholo ba phetseng hantle. PrimeC ke buka e qapiloeng ka molomo e entsoeng ka motsoako o ikhethileng oa litekanyetso tse peli tse amohetsoeng ke FDA: ciprofloxacin le celecoxib. PrimeC e etselitsoe ho shebana le mekhoa e mengata ea bohlokoa ea amyotrophic lateral sclerosis (ALS) e tlatsetsang ho senyeha ha motor neuron, ho ruruha, ho bokella tšepe le ho senyeha ha taolo ea RNA ho thibela tsoelo-pele ea ALS.     

PrimeC e ile ea fuoa lebitso la Orphan Drug Designation ke FDA le European Medicines Agency (EMA). NeuroSense e phethetse thuto ea bongaka ea Phase IIa e atlehileng ho fihlela lintlha tsa eona tsa polokeho le ts'ebetso e kenyeletsang ho fokotsa ts'ebetso le ho hema le liphetoho tse kholo ho matšoao a amanang le ALS a bophelo a bonts'ang ts'ebetso ea tlhaho ea PrimeC. Khampani e rera ho qala boithuto ba machaba bo laoloang ke sebaka sa IIb bo sa boneng habeli ho Q2 2022 ka tekanyetso e ntlafalitsoeng le moetso o ntlafalitsoeng o ikhethang.

Boithuto ba pharmacokinetic (NCT05232461) ke lengolo le bulehileng la Mokhahlelo oa Pele, o sa reroang, oa tekanyetso e le 'ngoe, kalafo e meraro, thuto ea nako e meraro ea crossover ho lekola phello ea lijo ho bioavailability ea PrimeC ha e bapisoa le bioavailability ea matlapa a ciprofloxacin a sebelisoang hammoho. le li-capsules tsa celecoxib ho batho ba baholo ba phetseng hantle ba 12 ba US.

"Boitsebiso bo tsoang thutong ea rona ea bongaka ea Phase IIa bo netefalitse hore PrimeC ke kalafo e ncha e nang le monyetla oa ho thusa batho ba nang le ALS le ho sebetsana le 'maraka oa $ 3 billion o hlokang kalafo e sebetsang haholoanyane," ho boletse CEO oa NeuroSense Alon Ben-Noon. "Ha re ntse re itokisetsa ho qala thuto ea rona ea Phase IIb likhoeling tse 'maloa tse tlang, sepheo sa thuto ea rona ea pharmacokinetic tlas'a FDA IND ke ho hlahisa lintlha tse eketsehileng mabapi le bioavailability ea PrimeC kaha e amana le ho ja lijo ho batho ba phelang hantle. Re ikemiselitse ka botebo ho ntlafatsa bophelo ba batho ba nang le ALS ’me re motlotlo ho hlahisa phekolo e ncha e ka bang teng ho sebetsana le lefu lena le rarahaneng.” 

NeuroSense e sa tsoa phatlalatsa mohato oa boraro oa tšebelisano ea eona le Sepetlele se Seholo sa Massachusetts se Boston bukeng ea Neuron-Derived Exosomes (NDEs) ho tsoela pele ho fumana liphetoho tsa tlhaho ho mafu a amanang le ALS le phello ea PrimeC ho lipheo tse amehang. Liphetho ho tsoa thutong ena li lebelletsoe Q2 2022.

NeuroSense e boetse e ntšetsa pele mananeo a lefu la Alzheimer bakeng sa mokhethoa oa eona oa lithethefatsi CogniC le lefu la Parkinson bakeng sa StabiliC. Lintlha tse tsoang lithutong tsa pele ho nako li lebelletsoe H2 2022, 'me ho latela tlhahiso ea IND ho FDA, NeuroSense e lebelletse ho qala lithuto tsa bongaka ka matšoao ana ho H1 2023.

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Avatar ea Linda Hohnholz

Linda Hohnholz

Mohlophisi e ka sehloohong bakeng sa eTurboNews e thehiloe ho eTN HQ.

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