Ukusulwa Kocwaningo Olusha Lokwelashwa kwe-ALS

I-NeuroSense Therapeutics Ltd. namuhla imemezele ukuthi ithole imvume kwa-US Food and Drug Administration (FDA) ukuqala ucwaningo lwe-pharmacokinetic lwe-PrimeC ezifundweni zabantu abadala abanempilo. I-PrimeC iyinoveli yokwakhiwa komlomo yokukhululwa okwandisiwe enoveli eyakhiwe inhlanganisela eyingqayizivele yomthamo ongaguquki wezidakamizwa ezimbili ezigunyazwe yi-FDA: i-ciprofloxacin ne-celecoxib. I-PrimeC yakhelwe ukuthi iqondise ngokubambisana izindlela ezimbalwa ezibalulekile ze-amyotrophic lateral sclerosis (ALS) ezifaka isandla ekuwohlokeni kwe-motor neuron, ukuvuvukala, ukunqwabelana kwensimbi kanye nokulawulwa okungalungile kwe-RNA ukuvimbela ukuqhubeka kwe-ALS.     

I-PrimeC yanikezwa i-Orphan Drug Designation yi-FDA kanye ne-European Medicines Agency (EMA). I-NeuroSense iqedele isifundo somtholampilo seSigaba IIa esihlangabezane ngempumelelo neziphetho zayo zokuphepha nokusebenza okuhlanganisa nokunciphisa ukonakala kokusebenza nokuphefumula kanye nezinguquko ezibalulekile ngokwezibalo kumaka webhayoloji ahlobene ne-ALS abonisa umsebenzi webhayoloji we-PrimeC. Inkampani ihlela ukuqalisa ucwaningo lwamazwe ngamazwe olulawulwa yi-placebo olulawulwa yi-Phase IIb oluyimpumputhe kabili ku-Q2 2022 ngomthamo othuthukisiwe kanye nokwakheka okuthuthukisiwe okuyingqayizivele.

Ucwaningo lwe-pharmacokinetic (NCT05232461) ilebula evulekile yeSigaba I, okungahleliwe, umthamo owodwa, ukwelashwa okuthathu, ucwaningo lwezikhathi ezintathu ukuze kuhlolwe umphumela wokudla ekutholakaleni kwe-bioavailability ye-PrimeC uma kuqhathaniswa nokutholakala kwamaphilisi e-ciprofloxacin asetshenziswa ngokubambisana. kanye namaphilisi e-celecoxib ezifundweni zabantu abadala ezinempilo eziyi-12 e-US.

"Idatha evela ocwaningweni lwethu lomtholampilo lweSigaba IIa yaqinisekisa ukuthi i-PrimeC iwukwelapha okunoveli okunamandla okusiza abantu abane-ALS futhi ibhekane nemakethe ebiza amaRandi ayizigidi eziyizinkulungwane ezintathu edinga ukwelashwa okuphumelelayo," kusho isikhulu seNeuroSense u-Alon Ben-Noon. “Njengoba silungiselela ukuqalisa isifundo sethu seSigaba IIb ezinyangeni ezimbalwa ezizayo, inhloso yocwaningo lwethu lwe-pharmacokinetic ngaphansi kwe-FDA IND ukukhiqiza idatha eyengeziwe mayelana nokutholakala kwe-bioavailability kwe-PrimeC njengoba kuhlotshaniswa nokudla kwabantu abanempilo. Sizibophezele ngokujulile ekuthuthukiseni izimpilo zabantu abane-ALS futhi siyaziqhenya ngokusungula indlela entsha yokwelapha engase ibe khona ukubhekana nalesi sifo esiyinkimbinkimbi.” 

I-NeuroSense isanda kumemezela isigaba sesithathu sokusebenzisana kwayo ne-Massachusetts General Hospital e-Boston enovelini ye-Neuron-Derived Exosomes (NDEs) ukuze iqhubeke nokunquma izinguquko zebhayoloji kuma-pathologies ahlobene ne-ALS kanye nomthelela we-PrimeC kokuhlosiwe okufanelekile. Imiphumela evela kulolu cwaningo ilindeleke ngo-Q2 2022.

I-NeuroSense futhi ithuthukisa izinhlelo ze-Alzheimer's ikhandidethi yayo yezidakamizwa i-CogniC kanye nesifo sika-Parkinson se-StabiliC. Idatha evela ezifundweni zangaphambi komtholampilo ilindelwe i-H2 2022, futhi kulandela ukuthunyelwa kwe-IND ku-FDA, i-NeuroSense ilindele ukuqalisa izifundo zomtholampilo kulezi zinkomba ku-H1 2023.