Ampio Pharmaceuticals, Inc., k'hamphani ea biopharmaceutical e shebaneng le nts'etsopele ea kalafo ea immunomodulatory bakeng sa maemo a tloaelehileng a ho ruruha, kajeno e phatlalalitse lintlha tse ntle ho tsoa ho palo e fetotsoeng ea Intent-to-Treat (mITT) thutong ea K'hamphani ea AP-013, teko ea bongaka ea Phase 3. ea mokhethoa ea ka sehloohong oa k'hamphani, Ampion™, ho bakuli ba nang le lefu la masapo le manonyeletso le matla la lengole (OAK).
Boithuto ba AP-013 bo ne bo etselitsoe ho netefatsa katleho e bonoang tekong ea pele ea bohlokoa, AP-003-A, mme e ile ea fuoa matla a ho bona phapang ea kalafo lipakeng tsa Ampion le taolo ea letsoai. Teko e ne e hloka palo e kholoanyane ea bakuli ho hlahloba ntlafatso ea mosebetsi, ho feta kamoo e neng e hloka ho hlahloba ntlafatso ea bohloko bo le bong. Boithuto ba AP-013 bo qalile ka Phuptjane 2019 mme bo ntse bo tsoela pele ha koluoa ea COVID-19 e etsahala, e bakileng palo e kholo ea data e sieo ka lebaka la seoa sena.
"Ka lebaka la lintlha tse ngata tse sieo, litlhahlobo tsa rona tsa data ea AP-013 li qalile ka ho sebelisa khothaletso ea FDA ea ho etsa tlhahlobo ea kutlo ho bona hore na ho bile le tšusumetso ea COVID-19 thutong, eo re e hlalositseng le ho e ngola. morerong oa ho ithuta pele o hlakola data, "ho boletse Holli Cherevka, Mopresidente oa Ampio le Ofisiri e ka Sehloohong ea Ts'ebetso. "Tlhahlobo ena ea kutloisiso e fumane tšusumetso e kholo ho tsoa ho COVID-19, 'me joalo ka ha ho boletsoe moralong oa rona oa thuto, re khothalelitse palo ea batho ba mITT ho lekola katleho. Sebakeng sena sa mITT (n = 618), se ileng sa boloka matla a fetang 85% ho hlahloba ntlafatso ea bohloko, Ampion o bontšitse ho fokotseha ho hoholo ha bohloko (p = 0.042) 'me ho na le mekhoa e metle ea ntlafatso ea ts'ebetso khahlanong le taolo ea letsoai. Ho feta moo, liphetho ho palo ea batho ba sebetsang hantle ka Protocol (n = 580), e kenyellelitsoeng moralong oa pele oa tlhahlobo ea lipalo-palo oa AP-013, e ts'ehetsa litebello tsena ka ho fokotseha ho hoholo ha bohloko (p = 0.020) le ntlafatso ea bohlokoa ea ts'ebetso. p = 0.027) khahlano le taolo ea letsoai."
Mike Martino, Mookameli ea ka Sehloohong le Molula-setulo oa Ampio o ile a phaella ka ho re, "Re lumela hore lintlha tsa AP-013 li tiisa liphello tse tsoang ho AP-003-A 'me li tšehetsa polokeho le katleho ea Ampion bakeng sa phekolo ea bohloko bo tsoang ho OAK e matla. Pejana selemong sena re ile ra kenya kopo ea kopano ea Mofuta oa C ho FDA. FDA e amohetse kopo ea rona mme e netefalitse hore e tla fana ka likarabo tse ngotsoeng lipotsong tsa rona joalo ka mohato o latelang. Ho ts'ehetsa boemo ba rona le ho tsebisa karabelo ea FDA, haufinyane re rometse sephutheloana sa lintlha tse qaqileng. Ke lumela hore re mocheng oa ho fana ka tlhaloso e hlakileng ho AP-013 bofelong ba halofo ea pele ea selemo sena, joalo ka ha re ne re tataisitsoe pele. "
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- “As a result of the large amounts of missing data, our analyses of the AP-013 data started with applying FDA’s recommendation to conduct a sensitivity analysis to determine if there was an impact of COVID-19 on the study, which we outlined and documented in a study plan prior to unblinding the data,”.
- , a biopharmaceutical company focused on the advancement of immunomodulatory therapies for common inflammatory conditions, today announced positive data from the modified Intent-to-Treat (mITT) population in the Company’s AP-013 study, a Phase 3 clinical trial of the company’s lead candidate, Ampion™, in patients suffering from severe osteoarthritis of the knee (OAK).
- Further, the results in the Per Protocol efficacy population (n = 580), included in the original AP-013 statistical analysis plan, support these observations with a statistically significant reduction in pain (p = 0.