Ia Aperila 2019, na ulufale ai HopeMed i se maliega laisene faʻapitoa i le lalolagi atoa ma Bayer AG i luga o le atinaʻeina ma le faʻatauina o se tagata monoclonal antibody e faʻatatau i le PRL receptor mo le togafitia o le gau o le lauulu tane ma le fafine, endometriosis, ma isi faʻamaʻi faʻamaʻi faʻatasi ma le dysregulated prolactin. (PRL) faailoilo. O lenei antibody ua faʻaalia uiga sili ona lelei i faʻataʻitaʻiga manu e aofia ai faʻataʻitaʻiga NHP ma suʻesuʻega saogalemu o tagata. O ana togafitiga mo faʻailoga autu e lua, endometriosis ma androgenetic alopecia, ua uma ona faʻamaonia e le US FDA mo faʻataʻitaʻiga ile Vaega II. Ole vaega II ole su'esu'ega ile falema'i ole HMI-115 ile endometriosis ua mae'a amataina le lesitalaina o tagata ma'i ile US ile fa'ai'uga o le 2021. O lona Vaega II fa'ata'ita'iga fa'ata'ita'iga mo le togafitiga o le androgenetic alopecia o se nofoaga tutotonu fa'avaomalo, fa'afuase'i, fa'alua tauaso, placebo- suʻesuʻega faʻatonutonu, lea ua fuafua e faia i le Iunaite Setete, Ausetalia ma isi atunuu.
Dr. Henri Doods, le Pule Sili o HopeMed, fai mai “Ou te matua mitamita lava ona ua faamaonia foi e le FDA la tatou IND lona lua lea o se tulaga taua tele mo la tatou kamupani talavou. O se laasaga taua i la tatou misiona e aumai muamua-i-Class ma tulaga ese'ese oloa i gasegase. O le endometriosis ma le alopecia o fa'ailoga ia o lo'o fa'atalitali ai ma'i mo ni togafitiga fou e fa'aleleia atili ai le lelei ma le saogalemu. O le manuia o le mauaina o faʻatagaga IND e lua i se taimi puʻupuʻu o se faʻamalosiaga mo le 'au atoa. Matou te matua tuuto atu e faʻamalosia atili ma faʻalauteleina a matou galuega suʻesuʻe ma faʻataʻitaʻiga e aumai ai ni togafitiga fou fou i gasegase i le lalolagi atoa.
OA MEA E AVEA MAI LENEI TUSI:
- Its Phase II clinical trial for the treatment of androgenetic alopecia is an international multi-center, randomized, double-blind, placebo-controlled study, which is planned to be carried out in the United States, Australia and other countries.
- In April 2019, HopeMed entered a world-wide exclusive license agreement with Bayer AG on the development and commercialization of a human monoclonal antibody targeting the PRL receptor for the treatment of male and female pattern hair loss, endometriosis, and other chronic diseases with dysregulated prolactin (PRL) signaling.
- The success of having two IND approvals in such a short period of time is an encouragement for the whole team.