Hoʻomaʻemaʻe i ka haʻawina hou no ka mālama ʻana i ka ALS

Ua hoʻolaha ʻo NeuroSense Therapeutics Ltd. i kēia lā ua loaʻa iā ia ka ʻae mai ka US Food and Drug Administration (FDA) e hoʻomaka i kahi noiʻi pharmacokinetic o PrimeC i nā kumuhana olakino olakino. ʻO PrimeC kahi moʻolelo hoʻopuka waha hoʻokuʻu lōʻihi i haku ʻia me kahi hui paʻa paʻa kūʻokoʻa o ʻelua mau lāʻau i ʻae ʻia e FDA: ciprofloxacin a me celecoxib. Hoʻolālā ʻia ʻo PrimeC e hoʻopaʻa i nā hana koʻikoʻi o ka amyotrophic lateral sclerosis (ALS) e hāʻawi i ka degeneration neuron motor, ʻāʻī, hōʻiliʻili hao a me ka hoʻoponopono RNA impaired e hiki ke pale i ka holomua o ALS.     

Ua hāʻawi ʻia ʻo PrimeC i ka Orphan Drug Designation e ka FDA a me ka European Medicines Agency (EMA). Ua hoʻopau ʻo NeuroSense i kahi noiʻi lapaʻau Phase IIa i hoʻokō kūleʻa i kona palekana a me ka hopena hopena me ka hōʻemi ʻana i ka hana a me ka hoʻohaʻahaʻa hanu a me nā loli koʻikoʻi i ka helu ʻana i nā hōʻailona olaola pili i ka ALS e hōʻike ana i ka hana olaola o PrimeC. Hoʻolālā ka Hui e hoʻomaka i kahi haʻawina multinational i hoʻopaʻa ʻia e ka Phase IIb double-blind placebo-controlled ma Q2 2022 me kahi maʻi i hoʻopaʻa ʻia a me kahi hoʻolālā hoʻonui kūʻokoʻa.

ʻO ka pharmacokinetic study (NCT05232461) he Phase I open-label, randomized, single-dose, ʻekolu lapaʻau, ʻekolu-manawa crossover study e loiloi i ka hopena o ka meaʻai i ka bioavailability o PrimeC i hoʻohālikelike ʻia i ka bioavailability o nā papa ciprofloxacin i lawelawe pū ʻia. a me ka celecoxib capsules i 12 kanaka makua ola kino ma ka US.

"Ua hōʻoia ka ʻikepili mai kā mākou Phase IIa clinical study ʻo PrimeC kahi lāʻau lapaʻau hou me ka hiki ke kōkua i ka poʻe me ka ALS a hoʻoponopono i kahi mākeke $3 biliona e pono ai ka mālama ʻoi aku ka maikaʻi," wahi a NeuroSense CEO Alon Ben-Noon. "Ke hoʻomākaukau nei mākou e hoʻomaka i kā mākou Phase IIb aʻo i nā mahina e hiki mai ana, ʻo ka pahuhopu o kā mākou noiʻi pharmacokinetic ma lalo o FDA IND ʻo ia ka hana ʻana i nā ʻikepili hou aʻe e pili ana i ka bioavailability o PrimeC e pili ana i ka ʻai ʻana i ka meaʻai i nā kānaka olakino. Hoʻoikaika nui mākou i ka hoʻomaikaʻi ʻana i ke ola o ka poʻe me ALS a haʻaheo mākou e hoʻomohala i kahi lāʻau lapaʻau hou e hoʻoponopono ai i kēia maʻi paʻakikī. 

Ua hoʻolaha aku nei ʻo NeuroSense i ke kolu o kāna hui pū ʻana me Massachusetts General Hospital ma Boston ma ka moʻolelo Neuron-Derived Exosomes (NDEs) e hoʻoholo hou i nā loli olaola i nā pathologies pili i ka ALS a me ka hopena o PrimeC i nā pahuhopu kūpono. Manaʻo ʻia nā hopena mai kēia noiʻi Q2 2022.

Ke holomua nei ʻo NeuroSense i nā papahana i ka maʻi o Alzheimer no kāna moho lāʻau lapaʻau ʻo CogniC a me ka maʻi o Parkinson no StabiliC. Manaʻo ʻia nā ʻikepili mai nā haʻawina preclinical H2 2022, a ma hope o ka hoʻouna ʻana o IND i ka FDA, manaʻo ʻo NeuroSense e hoʻomaka i nā haʻawina lapaʻau i kēia mau hōʻailona ma H1 2023.