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Osteoarthritis na Knee: Sabuwar Farfadowa don Rage Rage Ciwo

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Ampio Pharmaceuticals, Inc., wani kamfani na biopharmaceutical da ke mayar da hankali kan ci gaban hanyoyin kwantar da hankali na immunomodulatory don yanayin kumburi na yau da kullun, a yau ya sanar da tabbataccen bayanai daga gyare-gyaren Intent-to-Treat (mITT) yawan jama'a a cikin binciken AP-013 na Kamfanin, gwajin gwajin gwaji na Phase 3. na dan takarar jagoran kamfanin, Ampion ™, a cikin marasa lafiya da ke fama da matsanancin ciwon gwiwa na osteoarthritis (OAK).  

An tsara binciken AP-013 don tabbatar da ingancin da aka lura a cikin gwaji mai mahimmanci na farko, AP-003-A, kuma an ƙarfafa shi don gano bambance-bambancen jiyya tsakanin Ampion da sarrafa saline. Gwajin ya buƙaci adadin marasa lafiya da yawa don kimanta haɓakawa a cikin aiki, fiye da yadda ake buƙata don kimanta ingantawa a cikin ciwo kadai. An fara binciken AP-013 ne a watan Yuni 2019 kuma yana ci gaba lokacin da barkewar COVID-19 ta faru, wanda ya haifar da asarar bayanai da yawa saboda cutar.

"Sakamakon ɗimbin bayanan da suka ɓace, bincikenmu na bayanan AP-013 ya fara ne tare da amfani da shawarar FDA don gudanar da nazarin hankali don sanin ko akwai tasirin COVID-19 akan binciken, wanda muka zayyana kuma muka rubuta. a cikin wani shiri na nazari kafin a kwance bayanan, "in ji Holli Cherevka, Shugaban Ampio da Babban Jami'in Gudanarwa. "Wannan bincike na hankali ya sami tasiri mai mahimmanci daga COVID-19, kuma kamar yadda aka ƙayyade a cikin shirin bincikenmu, mun ba da shawarar yawan mITT don tantance ingancin. A cikin wannan mITT yawan (n = 618), wanda ya riƙe fiye da 85% iko don kimanta ingantawa a cikin ciwo, Ampion ya nuna raguwa mai mahimmanci a cikin ciwo (p = 0.042) kuma yana da kyau don inganta aiki tare da kulawar saline. Bugu da ari, sakamakon da aka samu a cikin Per Protocol inganci yawan (n = 580), wanda aka haɗa a cikin ainihin tsarin ƙididdigar ƙididdiga na AP-013, yana goyan bayan waɗannan abubuwan lura tare da raguwa mai mahimmanci a cikin ciwo (p = 0.020) da kuma ingantaccen ingantaccen aiki (p = 0.027). p = XNUMX) tare da sarrafa saline.

Mike Martino, Babban Jami'in Gudanarwa da Shugaban Ampio ya kara da cewa, "Mun yi imanin cewa bayanan AP-013 sun tabbatar da sakamakon daga AP-003-A kuma yana goyan bayan aminci da ingancin Ampion don maganin ciwo daga OAK mai tsanani. A farkon wannan shekarar mun ƙaddamar da buƙatun taron Nau'in C ga FDA. FDA ta amince da buƙatarmu kuma ta tabbatar za su ba da amsa a rubuce ga tambayoyinmu a matsayin mataki na gaba. Don tallafawa matsayinmu da sanar da martanin FDA, kwanan nan mun ƙaddamar da fakitin taƙaitaccen bayani. Na yi imani muna kan hanyar samar da haske kan AP-013 a ƙarshen rabin farkon wannan shekara, kamar yadda aka jagoranta a baya. "

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Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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