I-FDA isula ukwelashwa kwamanxeba okuhlinzwa ezigulini ezine-prediabetes, isifo sikashukela kanye nokukhuluphala

I-Ilya Pharma AB (iNkampani), okuyinkampani ye-immunotherapy esiteji somtholampilo namuhla imemezele ukuthi i-FDA isisule i-IND kumuntu wayo oholayo we-ILP100-Topical nokuthi Inkampani isheshisa ngokushesha amalungiselelo ocwaningo olukhulu lweSigaba 2, oluklanywe njengesilingo esibalulekile. I-ILP100-Topical iyi-immunotherapy yesigaba sokuqala eyenzelwe ukwelapha amanxeba okuhlinzwa ezigulini ezine-prediabetes, isifo sikashukela kanye nokukhuluphala. Lezi ziguli zinezinyanga ezibambezelekile ukuphulukiswa ngemva kokuhlinzwa kanye nengozi eyanda kakhulu yezinkinga ezimbi zesilonda.

U-Robert D. Galiano, MD, UProfesa Ohlangene we-FACS; UMqondisi Wocwaningo; I-Division of Plastic Surgery Northwestern University Feinberg School of Medicine, izoba nguMphenyi Kazwelonke Wokuxhumanisa kanye noSihlalo Wocwaningo kulolu cwaningo oluzobandakanya iziguli ezingama-260. Kulandela umsebenzi oqhubekayo we-Wound Experts/FDA Clinical Endpoints Project (WEF-CEP) kanye nezimo kwezinye izindawo ezifana ne-oncology kanye nesifo samathambo, isiphetho esiyinhloko esikhethiwe siyisiphetho esiyinhlanganisela sokuphulukiswa kwamahhala okuyinkimbinkimbi. Ucwaningo lunomklamo oguquguqukayo futhi luhlanganisa izingxenye ezimbili - eyokuqala ingxenye yokuthola umthamo bese eyesibili ingxenye yokuqinisekisa. Ngenxa yomklamo wokulawula wangaphakathi, lapho isiguli ngasinye sinamandla aso okulawula ngesilonda esisodwa selashwa nge-placebo kanye nenxeba elilodwa elaphathwa nge-ILP100-Topical, ucwaningo luncishiswa kakhulu, inani leziguli ezibhalisiwe liyancipha kanye nokuchema phakathi kwamaqembu okwelapha. incishisiwe.

UDkt Galiano uphawule wathi: “Akudingeki ukuthi umuntu abe nesifo sikashukela ukuze ahlaselwe yizithiyo ekupholeni kwesilonda, futhi akugcini nje ngokubukelwa phansi lokhu, kodwa futhi asinazo izindlela zokwelapha eziqondise lokhu kukhubazeka ekwelapheni. Umthelela wokukhuluphala uwubhubhane oluthule futhi uthinta zonke iziyalo zokuhlinzwa. Ukwelapha okuthuthukisa ukuphulukiswa kwesilonda sokuhlinzwa kungaholela emiphumeleni ethuthukisiwe kukho konke okukhethekile okuhlinzayo nezinqubo, hhayi nje ekwehliseni amabele. Ngakho-ke ngiyajabula ukuhola lolu cwaningo njengoba ngibone imiphumela encomekayo kakade etholwe u-Ilya esifundweni sabo seSigaba I.”

I-CEO ye-Ilya Pharma kanye NoMsunguli U-Evelina Vågesjö uyanezela: “Ukugunyazwa kufike ngokushesha kunalokho obekulindelwe, manje sesihlose ukwelapha isiguli sokuqala ku-Q3 kulo nyaka. Lesi futhi isikhathi esibalulekile ku-Ilya Pharma ngemva kwemizamo emangalisayo yeqembu lethu elikhulu. Ukusebenzisana eduze noDkt Galiano kanye neqembu lochwepheshe kanye nama-KOL sikholelwa ukuthi siklame idizayini yokuhlola ephelele ezobonisa izinzuzo ezishintsha ngempela ze-ILP100-Topical ezigulini, siqale ngalesi sibalo sabantu abasengozini. Ngaphezu kwalokho, lesi sigameko esiyingqopha-mlando siqinisekisa inkundla yethu ye-ILP-technology kanye nabanye abazongenela izidakamizwa ekuthuthukisweni esibone ukuthi bazuza isithakazelo esikhulayo.”