Sabuwar Gwajin Asibiti na Sabon Magungunan Bincike don Maganin Alopecia

A KYAUTA Kyauta 3 | eTurboNews | eTN
Written by Linda Hohnholz

Hope Medicine Inc., wani sabon kamfani na likitancin likitanci, kwanan nan ya ba da sanarwar cewa Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da aikace-aikacenta na Sabon Drug (IND) don nazarin lokaci na II don kimanta HMI-115, aji na farko. monoclonal antibody magani a cikin lura da androgen alopecia. A cikin 2021, HMI-115 ta rigaya ta karɓi Taimakon IND na FDA ta Amurka don gwajin asibiti na Phase II don maganin endometriosis.

A cikin Afrilu 2019, HopeMed ya shiga yarjejeniyar lasisi ta duniya baki ɗaya tare da Bayer AG kan haɓakawa da tallan rigakafin ƙwayar cuta ta ɗan adam wanda ke yin niyya ga mai karɓar PRL don kula da asarar gashi na maza da mata, endometriosis, da sauran cututtuka na yau da kullun tare da dysregulated prolactin. (PRL) alama. Wannan rigakafin ya nuna kyawawan halaye a cikin ƙirar dabba ciki har da ƙirar NHP da nazarin amincin ɗan adam. Magungunan sa don manyan alamomi guda biyu, endometriosis da androgenetic alopecia, duka FDA ta Amurka ta amince da su don gwajin asibiti na Phase II. The Phase II gwajin gwaji na asibiti na HMI-115 a cikin endometriosis ya riga ya fara yin rajistar haƙuri a Amurka a ƙarshen 2021. Gwajin sa na II na asibiti don kula da alopecia na androgenetic cibiyar ce ta duniya da yawa, bazuwar, makafi biyu, placebo- binciken da aka sarrafa, wanda aka tsara za a yi a Amurka, Australia da sauran ƙasashe.

Dokta Henri Doods, Shugaba na HopeMed, ya ce "Ina alfahari da cewa FDA ta kuma amince da IND na biyu wanda shine muhimmin ci gaba ga matasan kamfaninmu. Yana da muhimmin mataki zuwa manufar mu don kawo Na farko-in-Class da samfuran bambanta sosai ga marasa lafiya. Dukansu endometriosis da alopecia alamu ne inda marasa lafiya ke ɗokin jiran sabbin zaɓuɓɓukan magani tare da ingantaccen inganci da aminci. Nasarar samun amincewar IND guda biyu a cikin ɗan gajeren lokaci abin ƙarfafawa ne ga dukan ƙungiyar. Mun himmatu sosai don ƙara ƙarfafawa da faɗaɗa ayyukan R&D don kawo sabbin sabbin zaɓuɓɓukan warkewa ga marasa lafiya a duniya. "

 

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

  • Gwajin gwaji na asibiti na Phase II don maganin alopecia na androgenetic shine cibiyar sadarwa ta duniya da yawa, bazuwar, makafi biyu, binciken sarrafa wuribo, wanda aka shirya za'ayi a Amurka, Ostiraliya da sauran ƙasashe.
  • A cikin Afrilu 2019, HopeMed ya shiga yarjejeniya ta keɓantaccen lasisi na duniya tare da Bayer AG akan haɓakawa da tallan rigakafin ƙwayar cuta ta ɗan adam wanda ke yin niyya ga mai karɓar PRL don kula da asarar gashi na maza da mata, endometriosis, da sauran cututtuka na yau da kullun tare da dysregulated prolactin. (PRL) alama.
  • Nasarar samun amincewar IND guda biyu a cikin ɗan gajeren lokaci abin ƙarfafawa ne ga dukan ƙungiyar.

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Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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