Sabon Mataki a Gwajin Osteoarthritis na Knee A Faɗin Amurka

Paradigm Biopharmaceuticals yana sanar a yau a hukumance ƙaddamar da shirin gwajin asibiti na Amurka tare da kiyasin wurare 56 da aka tsara na gwajin asibiti a duk faɗin ƙasar don gudanar da gwaji mai mahimmanci na 3 don tallafawa rajistar Pentosan Polysulfate Sodium (PPS) don ciwon osteoarthritis (OA) na gwiwa . 

An kafa shi a cikin 2014, Paradigm Biopharmaceuticals ya sami nasarar ganowa, sake sakewa, da kuma haƙƙin mallaka na PPS, don kula da ciwo da kumburi, hade da cututtukan musculoskeletal ciki har da osteoarthritis (a ƙarƙashin alamar kasuwanci ta Zilosul®) da mucopolysaccharidosis cuta mai wuya. 

Paradigm tana faɗaɗa ayyukanta na Amurka don tallafawa karatun rajista don shirin OA. A lokaci guda Paradigm yana sanar da kunna hanyar sadarwa na gwaji na asibiti na lokaci 3 don Zilosul® don magance osteoarthritis na gwiwa. Wannan yana da mahimmanci yayin da osteoarthritis shine mafi yawan sanadin nakasa a tsakanin manya kuma yana shafar fiye da mutane miliyan 72 a fadin Amurka, Kanada, EU-5, da Ostiraliya.1,2

Manufar wannan binciken shine don auna canjin ciwo da aiki tare da allurar subcutaneous na PPS idan aka kwatanta da allurar subcutaneous na placebo a cikin mahalarta tare da ciwon kOA. Wannan mataki ne na 2, mai daidaitawa, bazuwar, makafi biyu, mai sarrafa wuribo, nazarin multicenter (US / AUS / UK / EU) wanda zai kimanta kashi da maganin maganin PPS a cikin mahalarta tare da ciwon kOA.

Mataki na 1 ya ƙunshi zaɓi na kashi 2b na lokaci, tare da mahalarta bazuwar karɓar tsarin kashi na 1 na 3 PPS ko placebo na makonni 6. Babban makasudin mataki na 1 shine zaɓi kashi don amfani a mataki na 2, adadin da aka zaɓa zai dogara ne akan ma'auni mafi kyau na inganci da aminci.

Mahalarta mataki na 1 za a keɓe su ba da gangan ba don karɓar:

• 1.5 mg/kg da aka lissafta don madaidaicin nauyin jiki (IBW) PPS sau biyu a mako

• 2 mg/kg IBW PPS sau ɗaya kowane mako + placebo sau ɗaya kowane mako

• Kafaffen kashi (100/150mg/180mg PPS ≤65/≥65 zuwa ≤90/>90 kg IBW) sau ɗaya mako + placebo sau ɗaya kowane mako

• Placebo sau biyu a mako

A mataki na 2, mahalarta za su kasance bazuwar 1: 1 don karɓar zaɓaɓɓen tsarin kashi na PPS ko placebo na makonni 6.

Babban mahimmanci a cikin binciken mahimmanci shine canji daga asali a ranar 56 a cikin WOMAC® zafi tare da sakamako na biyu ciki har da canji daga tushe a lokuta masu yawa zuwa ranar 168 a WOMAC® Pain da Aiki, Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararru na Canji da Rayuwa .

Kunna mataki na 3 a gwiwa OA gwajin asibiti a Amurka yana wakiltar wani muhimmin mataki a ci gaban Paradigm a matsayin jagora na duniya wajen sake dawo da magungunan da ake da su." In ji Shugaba na riko, Dokta Donna Skerrett. "Akwai bayanai masu ƙarfafawa waɗanda ke nuna cewa PPS ba kawai magani ne mai mahimmanci ba a cikin tafiyar da kula da ciwo, amma har ma don cututtuka masu gyare-gyaren gyare-gyare, wani gagarumin nasara na likita wanda ba ya wanzu don maganin osteoarthritis."

Ɗauki hanya mai hankali da agile ga R&D na asibiti, ƙwararrun ƙungiyar Paradigm sun gina da ci gaba da haɗin gwiwa mai ƙarfi da nasara tare da manyan masu binciken asibiti a fagen. Ta hanyar sake amfani da magungunan FDA da aka amince da su, Paradigm yana nufin rage lokacin sake zagayowar ci gaban miyagun ƙwayoyi don aikace-aikacen da aka zaɓa da kuma rage farashin ci gaba. Paradigm yana aiki tare tare da, kuma yana da keɓancewar samar da yarjejeniyoyin tare, mai mallakar kuma kawai FDA ta amince da masana'anta na PPS, bene pharmaChem.3

Daraktan hulda da masu saka hannun jari, Simon White, ya yi nuni da cewa wannan “hanyar zuwa kasuwa tana taimaka wa sikelin farashi a cikin ci gaban magunguna da kuma amfani da ƙarin mayar da hankali da albarkatu kan daidaita aikace-aikacen miyagun ƙwayoyi a duniya, da shirin na asibiti wanda ke da niyyar haɓaka gabatarwar Zilosul ga Amurka da sauran su. kasuwannin duniya.”