I-Lutris Pharma namuhla imemezele ukuthi isiqedile ukubhaliswa kwengxenye yesibili yesigaba sayo se-1/2 sokuhlolwa komtholampilo kwe-lead compound, LUT014, inhibitor ye-B-Raf esetshenziswe phezulu, yokwelapha i-radiation-induced dermatitis (RD) ezigulini ezine-radiation-induced dermatitis (RD) umdlavuza webele. Idatha yomugqa ophezulu ilindeleke engxenyeni yesithathu ka-2022.
Ingxenye yesibili elawulwa ngokungahleliwe, eyimpumputhe ephindwe kabili, elawulwa yi-placebo yocwaningo lwesigaba se-1/2 ibhalise inani leziguli ze-20 futhi iklanyelwe ukuhlola ukusebenza kahle kwe-LUT014 elawulwa ngokwesihloko ezigulini zomdlavuza webele ezine-RD. Iziguli zihlelwe ngokungahleliwe ngesilinganiso esingu-1:1 ukuze zithole i-LUT014 elawulwa ngokwesihloko noma i-placebo izinsuku ezingu-28, kulandelwa isikhathi sokulandelela esiyizinyanga ezingu-2.
Isiphetho esiyinhloko sengxenye yesibili ukushintsha kobunzima be-radiation dermatitis esekelwe kuhlu lwemibuzo oluzibikayo lwe-Dermatology Life Quality Index (QoL) ezinsukwini eziyi-14. Iziphetho zesibili zihlanganisa ushintsho ebucayini be-radiation dermatitis esekelwe kuhlu lwemibuzo lwe-Dermatology QoL kanye nezehlakalo zezehlakalo ezimbi ezivela ekwelapheni njengoba zihlolwe isikali sebanga se-Common Terminology Criteria for Adverse Events (CTCAE) ukusuka kwesisekelo kuya kumaviki ayi-12.
"Imiphumela eqinile ebonwe ezigulini eziyisishiyagalombili eNgxenyeni 1 yokuhlolwa kwe-LUT014 yokwelapha i-RD, yasinika ukuzethemba okwengeziwe emandleni alokhu kwelashwa futhi yasikhuthaza ukuba siqale ingxenye 2, ngaphambi kwalokho okwakulindelwe," kusho uBenjamin W. Corn, MD, Isikhulu Esiphezulu Sezokwelapha se-Lutris Pharma. “Kusenesidingo esibalulekile esingafinyeleli ezigulini ezinomdlavuza webele eziphethwe i-RD, okwamanje azikho izindlela zokwelashwa ezigunyaziwe zazo. I-LUT014 inendlela eyingqayizivele yokwenza okuhloswe ngayo ukulinganisa ukubhujiswa kwamaseli kungqimba oluyisisekelo lwesikhumba ngokuthuthukisa ukwanda kwamangqamuzana, ngaleyo ndlela kube namandla okubuyisela emuva imiphumela ye-RD.
"Ukubhaliswa kwesiguli sokugcina engxenyeni yesibili ephuphuthekile ingxenye yesibili yocwaningo lwethu lwesigaba 1/2 kusiletha esinye isinyathelo ekuthuthukisweni komtholampilo kwe-LUT014 njengokwelashwa kwe-RD," kusho uNoa Shelach, Ph.D., Isikhulu Esiphezulu se-RD. Lutris Pharma. “Kulinganiselwa ukuthi cishe ingxenye yeziguli ezinomdlavuza yelashwa ngokwelashwa ngemisebe, minyaka yonke, futhi iningi leziguli ezinomdlavuza wamabele, ikakhulukazi, lihlangabezana nohlobo oluthile lwe-RD. Ngokusekelwe endleleni yokusebenza ye-LUT014, sikholelwa ukuthi i-LUT104 ingaba nomthelela omkhulu kulesi sibalo sesiguli. Sibheke ngabomvu ukubika idatha eqinile evela kulesi sivivinyo engxenyeni yesithathu yalo nyaka.”
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The randomized, double-blind, placebo-controlled part two of the phase 1/2 study has enrolled a total of 20 patients and is designed to evaluate the efficacy of topically administered LUT014 in breast cancer patients with RD.
- “The strong results observed from the eight patients in Part 1 of the trial of LUT014 to treat RD, gave us additional confidence in the potential of this therapy and spurred us to begin part 2, earlier than anticipated,”.
- “Enrollment of the last patient in the blinded part two portion of our phase 1/2 study brings us one step further in the clinical development of LUT014 as a treatment for RD,”.
