Aravax, wani kamfani na kimiyyar halittu na mataki na asibiti wanda ya mayar da hankali kan haɓaka maganin farko na rashin lafiyar gyada wanda aka ƙera don zama lafiya, inganci da dacewa, a yau ya sanar da cewa ya sami koren haske don aikace-aikacen sa na New Drug (IND) daga Abinci na Amurka Gudanar da Magunguna (FDA).

PVX108 wani zamani ne na gaba, takamaiman maganin rigakafi ta hanyar amfani da peptides waɗanda ke wakiltar mahimman gutsuttsuran sunadaran gyada don yin daidai da ƙwayoyin T da ke haifar da rashin lafiyar gyada. Ana gudanar da shi sau ɗaya a kowane wata, an ƙera maganin ne don haifar da juriya ga furotin gyada daidai ba tare da damuwar aminci da ke hana amfani da magani kawai da aka yi rajista ba wanda ke amfani da tsantsa na halitta daga gyada. Kasancewar gabaɗayan allergens na gyada a cikin waɗancan tsantsa yana fallasa marasa lafiya ga manyan haɗarin anaphylaxis (Chu et al. The Lancet 2019).

IND za ta ƙyale Aravax ya ci gaba da shirin gwaji na asibiti na Phase 2 zuwa Amurka kuma ya fadada ayyukansa na duniya.

"Muna farin cikin raba cewa FDA ta yarda Aravax ya fara nazarin tasiri na Phase 2 don gano mafi kyawun kashi na PVX108 a cikin yara masu ciwon gyada a Amurka. Wannan yanki ne na warkewa da ba a kula da shi sosai, kuma mun yi imanin tsarinmu yana da fa'idodi masu yawa akan hanyoyin da ake da su tare da madaidaicin tsarin aiki da bayanin martabar amincin da aka riga aka tabbatar a cikin gwajin asibiti na Mataki na 1. " In ji Aravax Shugaba, Dr Pascal Hickey.

A baya can, wani bazuwar, makafi biyu, gwajin gwaji na Mataki na 1 a cikin 66 masu rashin lafiyar gyada (AVX-001) bai nuna alamun abubuwan da suka faru na damuwa na asibiti ba. Bugu da ƙari, nazarin ex vivo da ke ba da ma'aunin aminci (basophil kunnawa) a cikin masu ba da gudummawar jini na rashin lafiyar gyada 185 sun tabbatar da rashin amsawar basophil zuwa PVX108 da bambanci da cire gyada. Waɗannan bayanan sun nuna cewa PVX108 yana da ingantaccen bayanin martabar aminci don kula da marasa lafiyar gyada, gami da masu fama da rashin lafiya.

An ba da izinin farko na Aravax da ke rufe abun da ke cikin gubar PVX108 a cikin Amurka, EU da sauran hukunce-hukuncen. Ƙarin iyalai na haƙƙin mallaka kuma suna ci gaba da kyau a waɗannan hukunce-hukuncen.

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

"Muna farin cikin raba cewa FDA ta yarda Aravax ya fara nazarin tasiri na Phase 2 don gano mafi kyawun kashi na PVX108 a cikin yara masu ciwon gyada a Amurka.
Aravax, wani kamfani na kimiyyar halittu na mataki na asibiti wanda ya mayar da hankali kan haɓaka maganin farko don rashin lafiyar gyada wanda aka tsara don zama lafiya, inganci da dacewa, a yau yana sanar da cewa ya sami haske mai kore don aikace-aikacen sa na New Drug (IND) daga U.
Bugu da ƙari, nazarin ex vivo da ke ba da ma'aunin aminci (basophil activation) a cikin masu ba da gudummawar jini na rashin lafiyar gyada 185 sun tabbatar da rashin amsawar basophil zuwa PVX108 da bambanci da cire gyada.