Kuchotsedwa kwa Phunziro Latsopano la Chithandizo cha ALS

NeuroSense Therapeutics Ltd. lero yalengeza kuti yalandira chilolezo kuchokera ku US Food and Drug Administration (FDA) kuti ayambitse kafukufuku wa pharmacokinetic wa PrimeC mwa anthu akuluakulu athanzi. PrimeC ndi buku lapakamwa lotambasulidwa lomwe limapangidwa ndi kuphatikiza kwapadera kwamankhwala awiri ovomerezeka ndi FDA: ciprofloxacin ndi celecoxib. PrimeC idapangidwa kuti igwirizane ndi njira zingapo zofunika za amyotrophic lateral sclerosis (ALS) zomwe zimathandizira kuti motor neuron iwonongeke, kutupa, kuchulukira kwachitsulo komanso kuphwanya malamulo a RNA kuti alepheretse kupita patsogolo kwa ALS.     

PrimeC idapatsidwa dzina la Orphan Drug Designation ndi FDA ndi European Medicines Agency (EMA). NeuroSense idamaliza maphunziro achipatala a Phase IIa omwe adakwaniritsa bwino chitetezo chake komanso magwiridwe antchito ake kuphatikiza kuchepetsa kufooka kwa magwiridwe antchito ndi kupuma komanso kusintha kwakukulu kwa zolembera zokhudzana ndi ALS zokhudzana ndi chilengedwe zomwe zikuwonetsa zochitika zamoyo za PrimeC. Kampani ikukonzekera kuyambitsa kafukufuku wapadziko lonse wa Phase IIb wakhungu wopangidwa ndi placebo mu Q2 2022 ndi mlingo wokometsedwa komanso mawonekedwe ake apadera.

Phunziro la pharmacokinetic (NCT05232461) ndi Phase I lotseguka, losasinthika, mlingo umodzi, chithandizo chanthawi zitatu, kafukufuku wanthawi zitatu kuti awone momwe chakudya chimakhudzira kukhalapo kwa PrimeC poyerekeza ndi kupezeka kwa mapiritsi a ciprofloxacin omwe amathandizidwa nawo. ndi makapisozi a celecoxib mu maphunziro achikulire athanzi a 12 ku US.

"Zomwe zachokera ku maphunziro athu azachipatala a Phase IIa zatsimikizira kuti PrimeC ndi mankhwala atsopano omwe angathe kuthandiza anthu omwe ali ndi ALS ndikuthana ndi msika wa $ 3 biliyoni womwe ukufunika chithandizo chamankhwala," adatero Alon Ben-Noon, CEO wa NeuroSense. "Pamene tikukonzekera kuyambitsa phunziro lathu la Phase IIb m'miyezi ingapo ikubwerayi, cholinga cha kafukufuku wathu wamankhwala pansi pa FDA IND ndikuti tipeze zambiri pazachilengedwe za PrimeC zomwe zimakhudzana ndi kudya kwa anthu athanzi. Ndife odzipereka kwambiri pakuwongolera miyoyo ya anthu omwe ali ndi ALS ndipo ndife onyadira kupanga chithandizo chatsopano chothana ndi matendawa. ” 

NeuroSense posachedwapa yalengeza gawo lachitatu la mgwirizano wake ndi Massachusetts General Hospital ku Boston pa buku la Neuron-Derived Exosomes (NDEs) kuti adziwe zambiri za kusintha kwachilengedwe kwa matenda okhudzana ndi ALS ndi zotsatira za PrimeC pazolinga zoyenera. Zotsatira za kafukufukuyu zikuyembekezeka Q2 2022.

NeuroSense ikupititsanso patsogolo mapulogalamu a matenda a Alzheimer's kwa odwala omwe ali ndi mankhwala a CogniC ndi matenda a Parkinson a StabiliC. Zambiri zochokera kumaphunziro azachipatala zikuyembekezeka H2 2022, ndipo kutsatira kutumizidwa kwa IND ku FDA, NeuroSense ikuyembekeza kuyambitsa maphunziro azachipatala pazowonetsa izi mu H1 2023.