Aravax, kambani yekiriniki yebiotechnology kambani yakatarisana nekugadzira yekutanga kurapwa kwenzungu allergy iyo yakagadzirirwa kuve yakachengeteka, inoshanda uye nyore, nhasi inozivisa kuti yawana mwenje wegirinhi kune yayo Investigational New Drug (IND) application kubva kuUS Chikafu uye. Drug Administration (FDA).

PVX108 chizvarwa chinotevera, allergen-specific immunotherapy vachishandisa mapeptides anomiririra zvidimbu zvakakosha zvemapuroteni enzungu kuti anyatso kunanga masero eT anotyaira peanut allergies. Kunodzorwa kamwe chete pamwedzi, kurapa kwakagadzirirwa kunyatso kurudzira kushivirira kune peanut protein pasina kunetsekana kwekuchengetedza kumanikidza kushandiswa kweiyo chete yakanyoreswa kurapa iyo inoshandisa yakasikwa yakatorwa kubva munzungu. Kuvepo kweazere peanut allergens mune izvo zvinyorwa zvinoisa varwere njodzi dzakakura dzeanaphylaxis (Chu et al. The Lancet 2019).

Iyo IND ichabvumira Aravax kufambisira mberi Phase 2 chirongwa chekiriniki chekuyedza muUS uye kuwedzera mashandiro ayo epasirese.

"Isu tinofara kugovera kuti FDA yakabvumira Aravax kuti itange ongororo yeChikamu 2 yekuona muyero wakakwana wePVX108 muvana vane peanut allergies muUnited States. Iyi inzvimbo yekurapa haina kuchengetedzwa zvakanyanya, uye isu tinotenda kuti maitiro edu ane mabhenefiti akakosha pamusoro pekurapa kuripo nemaitiro ayo chaiwo ekuita uye nhoroondo yekuchengetedza yakatoratidzwa muChikamu chekutanga chekiriniki." akadaro Aravax CEO, Dr Pascal Hickey.

Kare, imwe nzira, yakapetwa kaviri-mapofu, placebo-inodzorwa Phase 1 muedzo mu66 peanut-allergic vanhu vakuru (AVX-001) yakaratidza hapana humbowo hwezviitiko zvakashata zvekunetseka kwekliniki. Pamusoro pezvo, zvidzidzo zve ex vivo zvinopa chiyero chekuchengetedza (basophil activation) mu185 peanut-allergic blood donors yakasimbisa kushaikwa kwebasophil reactivity kuPVX108 mukupesana nekutorwa kwenzungu. Idzi data dzinoratidza kuti PVX108 ine yakanakira kuchengetedza nhoroondo yekurapwa kwenzungu varwere vanorwara, kusanganisira avo vane allergy yakanyanya.

Aravax yekutanga patent inovhara inotungamira kuumbwa PVX108 yakapihwa zvakare muUS, EU nedzimwe nzvimbo. Mhuri dzepatent dzekuwedzera dziri kufambawo zvakanaka munzvimbo idzi.

ZVOKUBVA MUNYAYA INO:

“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.