I-Respira Therapeutics, Inc. imemezele namuhla ukuthi isiguli sokuqala e-United States sifakwe umthamo esivivinyweni se-multicenter sekhandidethi lomkhiqizo walo oholayo, i-RT234-PAH (i-vardenafil elawulwa njenge-powder eyomile yokwelashwa). Isivivinyo se-VIPAH-PRN 2b (i-Vardenafil Inhaled for Pulmonary Arterial Hypertension - PRN) izoba nama-cohorts amabili alandelanayo athola i-RT234 njengezilinganiso ezilodwa ezilawulwa nge-Axial Oscillating Sphere dry powder inhaler. Ucwaningo luklanyelwe ukuhlola ukuphepha nokusebenza kokuqala kwe-RT234 ukuze kuthuthukiswe ngokujulile izimpawu ze-episodic namandla okuzivocavoca kubantu abalashelwa i-pulmonary arterial hypertension (PAH) ngezimpawu ze-New York Heart Association (NYHA) ezisebenzayo zeClass II-III.
"Ukuqaliswa kwalolu cwaningo lomtholampilo kumelela ingqophamlando ebalulekile ye-Respira futhi kuyisinyathelo esilandelayo esibalulekile ekunikezeni iziguli ezine-PAH ukwelashwa okunamandla ukuze zilawule ukuphefumula kwazo, okubavimbela ukuba benze imisebenzi evamile yansuku zonke," kusho uCarol Satler, PhD. , MD, uMongameli kanye noMphathi Omkhulu Wezokwelapha we-Respira. “Abantu abaphethwe yilesi simo esicindezelayo futhi esibucayi abalashwa ngamakhambi esondlo basahlangabezana neziqephu zokuphefumula, ukukhathala nokungakwazi ukuzivocavoca, okwamanje azikho izindlela zokwelapha ezisheshayo ezitholakalayo ‘njengoba kudingeka’ ukuze kwehliswe lezi ziqephu. ”
"Ukuvumela iziguli ze-PAH ukuba zisebenze kakhulu kuyisihluthulelo sempilo yabo engokomzimba nengqondo," kusho uRaymond L. Benza, MD, uMqondisi we-Division of Cardiovascular Medicine e-Ohio State University Wexner Medical Center. “Manje ngocwaningo lwe-RT234, sihlola amandla ethu okuthuthukisa ukuvivinya umzimba lapho isiguli sikudinga. Kungase kube yisinyathelo esihle phambili empini yethu nalesi sifo.”
Isivivinyo se-VIPAH-PRN 2b (RT234-PAH-CL202) siwucwaningo lokwenyuka komthamo ukuze kuhlolwe izinguquko ezibucayi ezimpawu ngemuva kokuthatha umthamo we-RT234 ezihlokweni ezine-PAH. Kucatshangwa ukuthi i-RT234 ephefumulayo (i-vardenafil inhalation powder) ingase inikeze inzuzo yokwelapha ukuze isetshenziswe kanzima ezigulini ezine-World Health Organization (WHO) Iqembu le-1 Pulmonary Hypertension (PH) (Pulmonary Arterial Hypertension [PAH]) ukuthuthukisa amandla okuzivocavoca nokusebenza imisebenzi yokuphila kwansuku zonke, kanye nokunciphisa izimpawu zokuzikhandla (isb, i-dyspnea) kanye nomthelela wazo oyingozi kukhwalithi yempilo.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- Kucatshangwa ukuthi inhaled RT234 (vardenafil inhalation powder) ingase inikeze inzuzo yokwelapha ukuze isetshenziswe kanzima ezigulini ezine-World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) (Pulmonary Arterial Hypertension [PAH]) ukuthuthukisa umthamo wokuzivocavoca nokusebenza imisebenzi yokuphila kwansuku zonke, kanye nokunciphisa izimpawu zokuzikhandla (isib.
- "Ukuqaliswa kwalolu cwaningo lomtholampilo kumelela ingqopha-mlando ebalulekile ye-Respira futhi kuyisinyathelo esilandelayo esibalulekile ekunikezeni iziguli ezine-PAH ukwelashwa okunamandla ukuze zilawule ukuphefumula kwazo, okubavimbela ukuba benze imisebenzi evamile yansuku zonke,".
- Ucwaningo luklanyelwe ukuhlola ukuphepha nokusebenza kokuqala kwe-RT234 ukuze kuthuthukiswe ngokujulile izimpawu ze-episodic namandla okuzivocavoca kubantu abalashelwa i-pulmonary arterial hypertension (PAH) ngezimpawu ze-New York Heart Association (NYHA) ezisebenzayo zeClass II-III.