I-Aravax, inkampani ye-biotechnology esesiteji somtholampilo egxile ekuthuthukiseni ukwelashwa kokuqala kokungezwani komzimba namantongomane okuklanyelwe ukuthi kuphephe, kusebenze futhi kube lula, namuhla imemezela ukuthi ithole ukukhanya okuluhlaza ngohlelo lwayo lwe-Investigational New Drug (IND) oluvela e-US Food and Ukuphathwa Kwezidakamizwa (FDA).

I-PVX108 isizukulwane esilandelayo, i-allergen-specific immunotherapy isebenzisa ama-peptide amele izingcezu ezibalulekile zamaprotheni amakinati ukuze iqondise ngokunembile ama-T cell ashayela ukungezwani komzimba wamakinati. Kusetshenziswa kanye ngenyanga, ukwelapha kuklanyelwe ukugqugquzela ngokunembile ukubekezelela amaprotheni amakinati ngaphandle kokukhathazeka ngokuphepha okuvimbela ukusetshenziswa kokwelapha okubhalisiwe kuphela okusebenzisa okukhishwe kwemvelo kumantongomane. Ubukhona bezinto ezingezwani namantongomane kulezo zingcaphuno zibeka iziguli ezingozini ezinkulu ze-anaphylaxis (Chu et al. The Lancet 2019).

I-IND izovumela i-Aravax ukuthi iqhubekisele phambili uhlelo lwesilingo somtholampilo seSigaba 2 e-US futhi yandise ukusebenza kwayo emhlabeni jikelele.

"Sijabule ukwabelana ngokuthi i-FDA ivumele i-Aravax ukuthi iqale isifundo sokusebenza ngempumelelo kweSigaba 2 ukuze ibone umthamo ophelele we-PVX108 ezinganeni ezinokungezwani namantongomane e-United States. Lena indawo yokwelapha enganakwa kakhulu, futhi sikholelwa ukuthi indlela yethu inezinzuzo ezinkulu kunokwelashwa okutholakalayo ngendlela enembile yokusebenza kanye nephrofayili yokuphepha kakade efakazelwe ezinhlolweni zomtholampilo zeSigaba 1.” kusho isikhulu se-Aravax, uDkt Pascal Hickey.

Ngaphambilini, isilingo seSigaba 1 esilawulwa ngokungahleliwe, esiyimpumputhe esiphindwe kabili, esilawulwa yi-placebo kubantu abadala abangama-66 be-peanut-allergic (AVX-001) asibonisanga ubufakazi bezenzakalo ezimbi zokukhathazeka komtholampilo. Ukwengeza, izifundo ze-ex vivo ezihlinzeka ngesilinganiso sokuphepha (ukuqaliswa kwe-basophil) kwabanikela ngegazi le-peanut-allergic angu-185 ziqinisekise ukuntuleka kwe-basophil reactivity ku-PVX108 ngokungafani nokukhipha amantongomane. Le datha ikhombisa ukuthi i-PVX108 inephrofayili yokuphepha evumayo kakhulu yokwelashwa kweziguli ezingezwani nephenathi, okuhlanganisa nalabo abangezwani kakhulu.

Ilungelo lobunikazi lokuqala le-Aravax elimboza ukwakheka okuholayo i-PVX108 linikezwe e-US, EU nakwezinye izindawo. Imindeni eyengeziwe enamalungelo obunikazi nayo iqhubeka kahle kulezi zindawo.

LOKHO ONGAKUTHATHE KULESI SIHLOKO:

“We are excited to share that FDA has allowed Aravax to commence a Phase 2 efficacy study to identify the optimal dose of PVX108 in children with peanut allergy in the United States.
Aravax, a clinical stage biotechnology company focused on developing the first therapy for peanut allergy which is designed to be safe, effective and convenient, today announces that it has received a green light for its Investigational New Drug (IND) application from the U.
Additionally, ex vivo studies providing a surrogate measure of safety (basophil activation) in 185 peanut-allergic blood donors confirmed a lack of basophil reactivity to PVX108 in contrast to peanut extract.