Inkampani iPaxMedica, Inc., iBiopharmaceutical company egxile ekuphuhliseni amayeza anceda ukoyisa imicelimngeni yokuphila neemeko ezinzima zemithambo-luvo, namhlanje ibhengeze ukuba ifumene imvume kwi-Arhente yoLawulo lweeMveliso zezeMpilo yaseMzantsi Afrika (i-SAHPRA) ngesicelo sayo solingo lwezonyango iziphumo ze-PAX-101 (suramin intravenous (IV) infusions) kwizigulana ezine-Long COVID-19 Syndrome (LCS), ekwaziwa njenge-post-acute sequelae yosulelo lwe-SARS-CoV-2.
Uphononongo, i-PAX-LCS-101, iya kuba siSigaba 1B, kulindeleke, i-randomized, i-placebo-controlled, i-double-blind, i-multiple-dose study. Uphononongo kulindeleke ukuba luqalise ukubhalisa izigulane kwikota yokuqala yalo nyaka emva kokufumana imvume yeKomiti yeSizwe yeeNqobo zokuziphatha yoMzantsi Afrika.
I-LCS sisifo esimandundu, esineenkqubo ezininzi esikhokelela kumonakalo omkhulu wokusebenza kwabantu abaninzi emva kosulelo oluqatha lwe-COVID-19. Ukuxilongwa kwe-LCS kulucelomngeni njengoko kungekho vavanyo lukhethekileyo lokumisela ukuxilongwa. Nangona kukho iinkcazo ezininzi ezicetywayo kwiincwadi zonyango, abaninzi abaphandi bachaza i-LCS njenge-syndrome equka ixesha elide leempawu ezahlukeneyo zomzimba kunye ne-neuropsychiatric eziqhubekayo kwiiveki ze-12 okanye ngaphezulu ngaphandle kwengcaciso engenye. Uphononongo kulindeleke ukuba lubhalise abaguli abaneempawu eziqhubekayo kunye neempawu ze-LCS, emva kosulelo olubhalwe ngaphambili lwentsholongwane ye-COVID-19. Iimpawu ze-LCS kwisigulane ngasinye zinokuhluka kodwa zihlala ziquka ukukhathala, "inkungu yengqondo", intlungu, intloko ebuhlungu, ukuphefumula okufutshane, ubunzima bokugxila kunye nokunyamekela, ukuphazamiseka kokulala, i-orthostasis kunye nesiyezi, kunye nokunciphisa ukusebenza kunye neempawu ezininzi ezinxulumene nazo. njengentlungu edibeneyo kunye nemisipha, ukudakumba kunye nokuxhalaba.
I-LCS iye yaqatshelwa ukuba ifane ngokusondeleyo nenye ingxaki yosulelo lwasemva kwe-acute eyaziwa ngokuba yi-myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). Kuzo zombini iziphazamiso, ukudinwa luphawu olubalaseleyo kwaye uninzi lwezinye iimpawu eziphawulweyo ziyadibana. Zombini iimeko zinokubangela ukungakwazi ukusebenza okanye ukwenza imisebenzi eqhelekileyo kwaye kwiimeko ezinzima ze-ME/CFS, zibhalwe ukuba zihlala iminyaka, okukhokelela ekubeni abo bachaphazelekayo babe ngamakhaya, ukuba abakho ebhedini. I-PaxMedica iceba ukufunda i-PAX-101 njengonyango lwe-LCS kunye ne-ME/CFS.
Olu vavanyo lweklinikhi lucetywe ukuba lufunde ukhuseleko kunye nokunyamezela, ukusebenza kakuhle, kunye ne-PK yeedosi ezimbini ze-suramin (5 mg / kg kunye ne-10 mg / kg) kubantu abadala, iminyaka eyi-18 nangaphezulu, kunye ne-LCS.
Ngaphandle kwesidingo esibalulekileyo sonyango esingafezekiswanga sonyango lwe-LCS, akukho mayeza avunyiweyo ngoku kwesi sifo. Kukho ukuvumelana okukhulayo kwinzululwazi kunye noluntu lwezonyango malunga nesidingo sophando olungakumbi kwizinto ezibangela i-LCS, kunye nokuphazamiseka okunokuthi kwenzeke kwi-ME / CFS.
I-PAX-101 ikwangoku ikwiSigaba sesi-2 se-Autism Spectrum Disorder (“ASD”). Inkampani iphinda iphuhlise i-PAX-102, i-proprietary intranasal formulation ye-suramin, ye-ASD kunye nezinye izifo ze-neurologic.
