I-Direct Biologics imemezele namuhla ukuthi i-FDA igunyaze inkampani ukuthi iqhubeke nesivivinyo sayo somtholampilo seSigaba 3 isebenzisa umuthi wayo ophenywayo we-EV, i-ExoFlo, ukwelapha i-Acute Respiratory Distress Syndrome (ARDS) ngenxa ye-Covid-19. I-Direct Biologics iyinkampani yokuqala futhi ukuphela kwe-EV ukuthola imvume yeSigaba sesi-3 se-FDA yenkomba Yomuthi Omusha Wophenyo (IND) kuze kube manje.
Ukuhlolwa kweSigaba sesi-3 kuzokwenziwa ngaphansi kwegama lokuqala le-Regenerative Medicine Advanced Therapy (RMAT) eligunyazwe yi-FDA ngokwelashwa kwe-EV, okwenza i-Direct Biologics ibe ngenye yezinkampani ezingama-70 kuphela emlandweni we-FDA ezinikezwe ngokusemthethweni i-RMAT. . Njengendlela esheshayo nokuqokwa kwempumelelo, i-RMAT yasungulwa yi-FDA ukuze isheshise ukugunyazwa kwemithi ethembisayo yokuvuselela ebonisa amandla okwelapha izifo ezisongela ukuphila.
"Ukuthola imvume ye-FDA yeSigaba sesi-3 kuyingqopha-mlando ye-Direct Biologics," kusho u-Mark Adams, Umsunguli kanye Nomphathi Omkhulu. “Ngokuhambisana negama le-RMAT, manje sisendleleni esheshayo ebheke ekudayiseni umuthi ongasindisa impilo—i-ExoFlo. Lesi sivivinyo seSigaba sesi-3 esinesihloko esithi “Cisha i-Covid-19″ siwukuhlola kwamazwe ngamazwe, okuxubile, okungaboni kabili, okungahleliwe, esilawulwa yi-placebo esilawulwa yi-placebo. Inhloso yethu ukubhalisa iziguli ezine-ARDS ezindaweni zezibhedlela kulo lonke elase-US, Spain, India, Jordan, Egypt, Lebanon, naseNingizimu Afrika, kanye nokubonisa ukwehla okukhulu kokufa ngemva kokwelashwa nge-ExoFlo uma kuqhathaniswa nezinga lokunakekelwa kuphela. Njengamaphayona emkhakheni wezokwelapha ezivuselelayo, thina kwa-Direct Biologics sishintsha ikusasa lezokwelapha. ”
“Kungakhathaliseki ukuthi i-Covid-19 ihlala ingubhubhane noma iba ubhubhane, indawo eyodwa yesidingo esingahlangatshezwana nayo ihlala ifana: indlela yokwelapha esebenzayo ye-ARDS. Abantu abangaphezu kweminyaka engama-65 kanye nalabo abanezifo ezihambisanayo, uma sebengenwe yi-SARS-CoV-2, bazohlala besengozini yokuqhubekela phambili ekuthelelekeni okunzima kanye ne-ARDS, ”kusho uJoe Schmidt, Umsunguli kanye noMongameli. “Okwembula ukuphepha okuqinile kanye nokwehliswa okuthembisayo kokufa kwezinsuku ezingu-60, uhlolo lwethu lweSigaba 2 lubonise ukuthi i-ExoFlo ingenza umehluko omkhulu osindisa ukuphila ezigulini ezilaliswe esibhedlela nge-ARDS. Ukuthola imvume ye-FDA ukuze uqhubekele esigabeni sesi-3 kuyimpumelelo enkulu ngoba akukho ukwelashwa okwaziwayo kwe-ARDS. Odokotela neziguli emhlabeni wonke kudala belindele isixazululo.”
"Ukusebenzela ukuthuthukisa i-ExoFlo kuyilungelo," kusho uDkt. Vik Sengupta, Isikhulu Esiyinhloko Sezokwelapha. “Ukwanda kwemininingwane yomtholampilo kukhomba ukuthi i-ExoFlo iyisidakamizwa esiletha ithemba ekwelapheni kwesifo izinga lokunakekelwa kwaso lingazange libe ngcono emashumini eminyaka. Leli themba liqoshwe kabuhlungu yizindaba zeziguli ezithole ukwelashwa kwe-ExoFlo. Ngesonto eledlule, owesifazane waseVirginia waphinde wahlanganiswa nezingane zakhe ngemuva kokudonsa umoya ngemishini izinyanga ezi-2 ngenxa yokuthuthukisa i-ARDS ebangelwa yi-Covid-19. Kodwa emzamweni wokugcina wokusindisa impilo yesiguli, odokotela base-ICU bacela ukuselapha nge-ExoFlo ngaphansi kokusetshenziswa kozwela, futhi welulama ngendlela eyisimangaliso. Kunezigidi zabantu abafana naye abangakaze baphumelele esibhedlela. Sifuna ukushintsha leyo ndaba ngokusungula i-ExoFlo njengendlela yokwelapha evamile ye-ARDS futhi siyenze ifinyeleleke ezigulini ezibhedlela emhlabeni jikelele.”
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the FDA for an EV therapeutic, making Direct Biologics one of only 70 companies in the history of the FDA to have been officially awarded RMAT.
- “The growing body of clinical data indicates that ExoFlo is a drug that brings hope to the treatment of a disease for which the standard of care has not improved in decades.
- Our objective is to enroll patients with ARDS in hospital sites across US, Spain, India, Jordan, Egypt, Lebanon, and South Africa, and to demonstrate a significant mortality reduction following treatment with ExoFlo compared to standard of care alone.
