Isigaba esitsha kuVango lweKlinikhi ye-Knee Osteoarthritis kulo lonke elase-US

IParadigm Biopharmaceuticals ibhengeza namhlanje ukuphehlelelwa ngokusemthethweni kwenkqubo yabo yovavanyo lweklinikhi yase-US kunye neqikelelo ye-56 ecwangcisiweyo yovavanyo lwendawo kwilizwe lonke ukuze kuqhutywe uvavanyo olubalulekileyo lwesigaba sesi-3 ukuxhasa ukubhaliswa kwePentosan Polysulfate Sodium (PPS) ye-osteoarthritis (OA) yedolo. . 

Eyasungulwa kwi-2014, i-Paradigm Biopharmaceuticals ichongiwe ngempumelelo, ibuyiselwe, kunye ne-PPS enelungelo lobunikazi, ekulawuleni intlungu kunye nokuvuvukala, okuhambelana nokuphazamiseka kwe-musculoskeletal okubandakanya i-osteoarthritis (phantsi kwe-trademark Zilosul®) kunye nesifo esinqabileyo se-mucopolysaccharidosis. 

IParadigm yandisa imisebenzi yayo yase-US ukuxhasa izifundo zobhaliso lwenkqubo ye-OA. Ngaxeshanye iParadigm ibhengeza ukuqaliswa kwesigaba se-3 senethiwekhi yovavanyo lwekliniki lweZilosul® ukunyanga i-knee osteoarthritis. Oku kubalulekile njengoko i-osteoarthritis iyona nto ibangela ukukhubazeka phakathi kwabantu abadala kwaye ichaphazela abantu abangaphezu kwezigidi ezingama-72 kulo lonke elase-US, eCanada, e-EU-5 nase-Australia.1,2

Injongo yolu phononongo kukulinganisa utshintsho kwiintlungu kunye nokusebenza ngeenaliti ezingaphantsi kwe-PPS xa kuthelekiswa nenaliti engaphantsi kwe-placebo kubathathi-nxaxheba abaneentlungu ze-kOA. Le yinqanaba le-2, i-adaptive, i-randomized, i-double-blind, i-placebo-controlled, i-multicenter (i-US / AUS / UK / EU) isifundo esiya kuvavanya umthamo kunye nomphumo wonyango we-PPS kubathathi-nxaxheba abaneentlungu ze-kOA.

Inqanaba le-1 libandakanya ukukhethwa kwe-dose ye-2b, kunye nabathathi-nxaxheba abafumana i-1 ye-3 ye-PPS i-dose regimens okanye i-placebo kwiiveki ze-6. Injongo ephambili yenqanaba le-1 kukukhetha umthamo wokusetyenziswa kwinqanaba le-2, idosi ekhethiweyo iya kusekelwe kwibhalansi efanelekileyo yokusebenza kunye nokhuseleko.

Abathathi-nxaxheba kwisigaba 1 baya kwabelwa ngokungacwangciswanga ukufumana:

• I-1.5 mg / kg ibalwe ubunzima bomzimba obufanelekileyo (IBW) PPS kabini ngeveki

• 2 mg/kg IBW PPS kanye ngeveki + placebo kanye ngeveki

• Idosi emiselweyo (100/150mg/180mg PPS ≤65/≥65 ukuya ≤90/>90 kg IBW) kanye ngeveki + i-placebo kanye ngeveki

• Placebo kabini ngeveki

Kwinqanaba lesi-2, abathathi-nxaxheba baya ku-1: 1 ukuba bafumane irejimeni yedosi ekhethiweyo ye-PPS okanye i-placebo kwiiveki ze-6.

Isiphelo esiphambili kwisifundo esibalulekileyo lutshintsho olusuka kwisiseko kwi-Day 56 kwintlungu ye-WOMAC® kunye neziphumo zesibini ezibandakanya utshintsho olusuka kwisiseko kumanqaku amaninzi ukuya kwi-168 kwi-WOMAC® Pain and Function, i-Palent Global Impression of Change and Quality of Life. .

"Ukuqaliswa kwenqanaba lesi-3 kulingo lwezonyango lwe-OA edolweni e-US kumele inyathelo elibalulekileyo ekukhuleni kweParadigm njengenkokeli yehlabathi ekubuyiseleni amachiza akhoyo." Uthi i-CEO yeThutyana, uGqr. Donna Skerrett. "Kukho idatha ekhuthazayo ebonisa ukuba i-PPS ayilonyango olusebenzayo kuphela ekulawuleni iintlungu, kodwa nakwisifo sokuguqula amandla, impumelelo ebalulekileyo yonyango engekhoyo kunyango lwe-osteoarthritis."

Ukwamkela indlela ekrelekrele kunye ne-agile kwi-R&D yeklinikhi, iqela elinamava leParadigm liye lakha kwaye lagcina intsebenziswano eyomeleleyo nenempumelelo kunye nabaphandi abaphambili beklinikhi kwintsimi. Ngokuphinda kusetyenziswe amachiza avunyiweyo e-FDA, iParadigm ijolise ekunciphiseni ixesha lomjikelo wophuhliso lwamachiza kwizicelo ezikhethiweyo kunye nokunciphisa iindleko zophuhliso. IParadigm isebenza ngekonsathi kunye, kwaye inezivumelwano zokubonelela ezikhethekileyo kunye, umnini kunye nomvelisi ovunyiweyo we-FDA we-PPS kuphela, bene-pharmaChem.3

UMlawuli woBudlelwane boMtyali-mali, uSimon White, ugxininise ukuba le "ndlela yokuthengisa inceda iindleko zeParadigm ekuphuhliseni iziyobisi kunye nokusebenzisa ugxininiso olongezelelweyo kunye nezibonelelo ekungqinelaniseni isicelo sechiza kwihlabathi jikelele, kunye nenkqubo yekliniki ejonge ukukhawulezisa ukuqaliswa kweZilosul e-US kunye nezinye. iimarike zehlabathi.”