ʻO PaxMedica, Inc., kahi hui biopharmaceutical e kālele ana i ka hoʻomohala ʻana i nā lāʻau e kōkua i ka lanakila ʻana i nā pilikia o ka noho ʻana me nā kūlana neurological paʻakikī, i kēia lā ua hoʻolaha ua loaʻa iā ia ka ʻae mai ka South Africa Health Products Regulatory Agency (SAHPRA) no kāna noi hoʻokolohua lapaʻau e aʻo i ka nā hopena o PAX-101 (suramin intravenous (IV) infusions) i nā poʻe maʻi me Long COVID-19 Syndrome (LCS), i ʻike ʻia hoʻi ʻo post-acute sequelae o ka maʻi SARS-CoV-2.
ʻO ke aʻo ʻana, PAX-LCS-101, he Phase 1B, prospective, randomized, placebo-controlled, double-blind, multiple-dose study. Manaʻo ka haʻawina e hoʻomaka i ka hoʻopaʻa inoa ʻana i nā maʻi i ka hapaha mua o kēia makahiki ma hope o ka loaʻa ʻana o ka ʻae ʻana o ke Kōmike Ethics National South Africa.
He maʻi koʻikoʻi ʻo LCS, multi-system e hopena i ka hōʻino nui o ka hana ʻana i nā poʻe he nui ma hope o ka maʻi maʻi me COVID-19. He mea paʻakikī ka hōʻailona o ka LCS no ka mea ʻaʻohe hoʻokolohua kikoʻī e hoʻokumu i ka maʻi. ʻOiai he nui nā wehewehe i manaʻo ʻia i loko o ka palapala lapaʻau, wehewehe ka hapa nui o nā mea noiʻi i ka LCS ma ke ʻano he maʻi maʻi e loaʻa ana kahi papa lōʻihi o nā hōʻailona kino a me nā neuropsychiatric e hoʻomau nei no nā pule he 12 a ʻoi aku me ka ʻole o ka wehewehe ʻana. Manaʻo ka haʻawina e kākau inoa i nā mea maʻi me nā hōʻailona mau a me nā hōʻailona o LCS, ma hope o kahi maʻi i kākau mua ʻia me ka maʻi COVID-19. ʻO nā hōʻailona o ka LCS i kēlā me kēia maʻi hiki ke ʻokoʻa akā pinepine ka luhi, "ka noe lolo", ʻeha, ʻeha poʻo, pōkole o ka hanu, paʻakikī me ka noʻonoʻo a me ka nānā ʻana, ka haunaele o ka hiamoe, orthostasis a me ka dizziness, a me ka emi ʻana o ka hana a me nā hōʻailona like ʻole. e like me ka ʻeha a me ka ʻiʻo, ke kaumaha a me ka hopohopo.
Ua ʻike ʻia ka LCS e like me kekahi maʻi maʻi post-acute i kapa ʻia ʻo myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). Ma nā maʻi ʻelua, he hōʻailona koʻikoʻi ka luhi a ʻoi aku ka nui o nā hōʻailona ʻē aʻe i ʻike ʻia. Hiki i nā kūlana ʻelua ke hopena i ka hiki ʻole ke hana a hana i nā hana maʻamau a i nā hihia koʻikoʻi o ME/CFS, ua kākau ʻia e mau makahiki, e hopena ai i ka poʻe i hoʻopilikia ʻia i ka home-, inā ʻaʻole pili i kahi moe. Hoʻolālā ʻo PaxMedica e aʻo i ka PAX-101 ma ke ʻano he lapaʻau no ka LCS a me ME/CFS.
Hoʻolālā ʻia kēia hoʻokolohua lapaʻau e aʻo i ka palekana a me ka tolerability, efficacy, a me PK o ʻelua mau kau o suramin (5 mg / kg a me 10 mg / kg) i nā pākeke, 18 mau makahiki a ʻoi aku, me LCS.
ʻOiai ka nui o ka pono lapaʻau kūpono ʻole no ka mālama ʻana iā LCS, ʻaʻohe lāʻau lapaʻau i ʻae ʻia i kēia manawa no kēia maʻi. Ke ulu nei ka manaʻo i loko o ka ʻepekema a me nā kaiāulu olakino e pono ai ka noiʻi hou aku i nā kumu o ka LCS, a me ka maʻi pili pili ME/CFS.
Aia ʻo PAX-101 i ka Phase 2 no ka Autism Spectrum Disorder (“ASD”). Ke hoʻomohala nei ka Hui i ka PAX-102, kahi hana intranasal proprietary o suramin, no ka ASD a me nā maʻi neurologic ʻē aʻe.
