Ukususwa koPhononongo olutsha loNyango lwe-ALS

I-NeuroSense Therapeutics Ltd. namhlanje ibhengeze ukuba ifumene imvume kwi-US Food and Drug Administration (FDA) ukuqalisa uphando lwe-pharmacokinetic lwe-PrimeC kwizifundo zabantu abadala abanempilo. I-PrimeC yinoveli yokwenziwa komlomo okwandisiweyo okudityanisiweyo okudityanisiweyo okukodwa kwedosi emiselweyo yamachiza amabini avunywe yi-FDA: i-ciprofloxacin kunye ne-celecoxib. I-PrimeC yenzelwe ukujolisa ngokubambisana kwiindlela ezininzi eziphambili ze-amyotrophic lateral sclerosis (ALS) ezinegalelo ekuwohlokeni kwe-motor neuron, ukudumba, ukuqokelelwa kwentsimbi kunye nokulawulwa kokuphazamiseka kwe-RNA ukuze kuthintelwe ukuqhubeka kwe-ALS.     

I-PrimeC inikwe i-Orphan Drug Designation yi-FDA kunye ne-Arhente ye-European Medicines Agency (EMA). I-NeuroSense igqibe iSigaba se-IIa sophononongo lweklinikhi oluye lwadibana ngempumelelo neziphelo zalo zokhuseleko kunye nokusebenza ngempumelelo okubandakanya ukunciphisa ukusebenza kunye nokuwohloka kokuphefumla kunye notshintsho olubalulekileyo lwezibalo kwiimpawu zebhayoloji ezinxulumene ne-ALS ezibonisa umsebenzi webhayoloji wePrimeC. Inkampani iceba ukuqalisa iSigaba se-IIb sophando lwe-placebo olulawulwa ngamazwe ngamazwe oluyimfama oluphindwe kabini kwi-Q2 2022 kunye nedosi ephuculweyo kunye nolwakhiwo olulodwa oluphuculweyo.

Uphononongo lwe-pharmacokinetic (NCT05232461) siSigaba I esivulekileyo-ileyibhile, i-randomized, idosi enye, unyango oluthathu, uphononongo lwe-crossover lwexesha ezintathu ukuvavanya umphumo wokutya kwi-bioavailability ye-PrimeC xa kuthelekiswa ne-bioavailability ye-co-administered ciprofloxacin tablets. kunye ne-celecoxib capsules kwizifundo zabantu abadala ezinempilo ezili-12 e-US.

"Idatha evela kwiSigaba se-IIa sophononongo lweklinikhi yaqinisekisa ukuba i-PrimeC lunyango lwenoveli olunamandla okunceda abantu abane-ALS kunye nokujongana ne-3 yeebhiliyoni zeedola ezifuna unyango olusebenzayo," utshilo u-CEO we-NeuroSense u-Alon Ben-Noon. “Njengoko silungiselela ukuqalisa isifundo sethu seSigaba sesi-IIb kwiinyanga ezimbalwa ezizayo, injongo yophononongo lwethu lwe-pharmacokinetic phantsi kwe-FDA IND kukuvelisa idatha eyongezelelweyo malunga nokufumaneka kwe-bioavailability ye-PrimeC njengoko ihambelana nokutya kubantu abasempilweni. Sizimisele ngokunzulu ekuphuculeni ubomi babantu abane-ALS kwaye siyaziqhenya ngokuphuhlisa unyango olutsha olunokubakho ukulungisa esi sifo sinzima.” 

I-NeuroSense isanda kwazisa inqanaba lesithathu lentsebenziswano kunye ne-Massachusetts General Hospital eBoston kwinoveli ye-Neuron-Derived Exosomes (NDEs) ukuqhubela phambili ukugqiba utshintsho lwebhayoloji kwii-pathologies ezinxulumene ne-ALS kunye nefuthe le-PrimeC kwiithagethi ezifanelekileyo. Iziphumo kolu phononongo zilindeleke Q2 2022.

I-NeuroSense ikwaqhubela phambili neenkqubo kwisifo sika-Alzheimer kumgqatswa wayo weziyobisi iCogniC kunye nesifo sikaParkinson seStabiliC. Idatha evela kwizifundo zangaphambi kweklinikhi kulindeleke i-H2 2022, kwaye ilandela ukungeniswa kwe-IND kwi-FDA, i-NeuroSense ilindele ukuqalisa izifundo zeklinikhi kwezi zibonakaliso kwi-H1 2023.