I-Lyra Therapeutics, Inc. namhlanje ibhengeze ukuba isigulane sokuqala saphathwa kwiSigaba 1 / inxalenye engeyiyo-randomized yeSigaba se-2 BEACON yolingo lwekliniki ye-LYR-220 kwizigulane zabantu abadala abane-rhinosinusitis engapheliyo (CRS) abaye benza utyando lwangaphambili lwe-sinus. I-LYR-220 yenzelwe ngokukodwa ukuhambisa iinyanga ezintandathu zeyeza eziqhubekayo zokulwa nokuvuvukala ngendlela elawulwayo kunye neyokuguquguqukayo kwiipaseji ze-sinonasal kwizigidi zezigulane ze-CRS eziqhubeka zifuna unyango ngaphandle kokuhlinzwa kwangaphambili. Iziphumo eziphambili kwiCandelo loku-1 leSigaba sesi-2 solingo lwe-BEACON zilindeleke ekupheleni konyaka.
"Sinokhetho olulinganiselweyo noluhlala lungasebenzi ukuze sinciphise iimpawu eziqhubekayo, ezinomthwalo kwizigulane ze-CRS eziye zatyandwa ngaphambili," watsho uAnders Cervin, MD, PhD, uSihlalo weNjingalwazi kwi-Otolaryngology kwiZiko loPhando lweKliniki, iRoyal Brisbane kunye neSibhedlele sabasetyhini. Ikhampasi, iHerston, eQueensland, eOstreliya, kunye noMphandi oyiNtloko kwisifundo seBEACON. "I-LYR-220 inokumela ukuqhubela phambili okunentsingiselo kukhathalelo lwaba baguli bangekagcinwa, uninzi lwabo lungenalo unyango oluvunyiweyo lwamayeza."
Ulingo lweSigaba sesi-2 se-BEACON luphononongo olulawulwayo lweqela elihambelanayo lokuvavanya ukhuseleko, ukunyamezela, i-pharmacokinetics, kunye nokusebenza ngokuthelekisa iiyilo ezimbini ze-LYR-220 (7500µg MF) matrix ukulawula, kwixesha leeveki ezingama-24, malunga ne-70 yabantu abadala abaneempawu. Izifundo ze-CRS eziye zatyandwa ngaphambili kwi-sinus. Ingxenye ye-1 yinto engabonakaliyo, i-open-label study ehlola ukuba nokwenzeka kokubekwa kokuphucula inkqubo, ngelixa iCandelo le-2 liya kuba yimfama-imfama, i-1: i-1: i-1 yokuhlola i-randomized designs ezimbini ngokubhekiselele kulawulo lwe-sham. Inkampani ilindele ukugqibezela ubhaliso lweSigaba sesi-2 esipheleleyo solingo lwe-BEACON ekupheleni konyaka.
"Oku kubonisa isiganeko esibalulekileyo eLyra njengoko siqhubela phambili umgqatswa wethu wesibini wemveliso yeCRS kuphuhliso lwasemva kwexesha, esibeka kwindawo yokuba sibe ngabokuqala ukubonelela ngezisombululo zezigulane ze-CRS ezinyangwa ngoogqirha be-ENT," utshilo uMaria Palasis, PhD. , uMongameli kunye neGosa eliLawulayo eliyiNtloko leLyra Therapeutics. "Sijonge phambili ekuqhubeleni phambili i-LYR-220 ngokusebenzisa iklinikhi kunye nokusebenzisa indlela ye-LYR-210, unyango lwethu lophando lwezigulane ze-CRS ezine-anatomy yotyando, okwangoku kulingo olubalulekileyo lweSigaba sesi-3 (KHANISA I), kwiifayile zokulawula kwixesha elizayo. ”
INTO ONOKUYITHATHA KWELI NQAKU:
- The Phase 2 BEACON trial is a controlled parallel-group study to evaluate safety, tolerability, pharmacokinetics, and efficacy comparing two designs of the LYR-220 (7500µg MF) matrix to control, over a 24-week period, in approximately 70 symptomatic adult CRS subjects who have had a prior bilateral sinus surgery.
- today announced that the first patient was treated in the Part 1/non-randomized portion of the Phase 2 BEACON clinical trial of LYR-220 in adult patients with chronic rhinosinusitis (CRS) who have had a prior sinus surgery.
- LYR-220 is specifically designed to deliver six months of continuous anti-inflammatory medication in a controlled and consistent fashion to the sinonasal passages for the millions of CRS patients that continue to require treatment despite a prior surgery.
