{"id":8232,"date":"2026-03-26T11:00:37","date_gmt":"2026-03-26T10:00:37","guid":{"rendered":"https:\/\/www.seedcapitalbizkaia.eus\/mikrobiomik-lanzara-la-primera-terapia-de-microbioma-humano-este-ano-en-espana\/"},"modified":"2026-04-13T11:53:34","modified_gmt":"2026-04-13T09:53:34","slug":"mikrobiomik-lanzara-la-primera-terapia-de-microbioma-humano-este-ano-en-espana","status":"publish","type":"post","link":"https:\/\/www.seedcapitalbizkaia.eus\/eu\/mikrobiomik-lanzara-la-primera-terapia-de-microbioma-humano-este-ano-en-espana\/","title":{"rendered":"Mikrobiomikek Europak mikrobiota garatuan oinarritutako lehen terapia biologikoari emandako onarpena ospatu du"},"content":{"rendered":"

Mikrobiomik euskal biofarmazia enpresa 2018an sortu zen, Seed Capital Bizkaiaren partaidetzarekin, eta Europako SoHO Erregelamendu berriaren pean baimen bat lortu duen lehen konpainia europarra da.<\/h3>\n

Mikrobiomikek beste mugarri bat nabarmendu du bere garapenean Europak EUTEGRA (MBK 01) onartu ondoren. Clostridioides difficile (ICD) bidezko infekzioa tratatzeko hesteetako mikrobiotan oinarritutako lehen terapia biologikoa da. Onarpen horrekin, Mikrobiomik Espainiako estatuan jarraibide terapeutiko hori duen mikrobiota fekala prestatzeko eta prozesatzeko baimendutako lehen laborategia da.<\/p>\n

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Aurrerapen aitzindaria mikrobiotan oinarritutako terapietan<\/strong><\/h3>\n

EUTEGRA (MBK 01), FSPIM\u00ae (Full Spectrum Purified Intestinal Mikrobiota) teknologiaren bidez garatutako kapsula bidezko ahozko terapia da, eta balioztatutako emaile osasuntsu baten ekosistema bakteriano osoa du. Helburua infekzio horren ondoriozko infekzio errepikariak dituzten pazienteei mikrobiota funtzionala berrezartzea da.<\/p>\n

Estandar antibiotikoaren aldean, tratamendu horrek %\u00a050 baino gehiago murrizten ditu ICDaren errepikapenak, eta horrek eragin kliniko eta ekonomiko esanguratsua du osasun sisteman.<\/p>\n

\n

Erreferentziazko lorpen arautzailea Europan<\/strong><\/h3>\n

Baimena Euskal Autonomia Erkidegoko Transplanteen Koordinazio Autonomikoaren bidez izapidetu da, Transplanteen Erakunde Nazionalaren (ONT) eta Berrikuntzaren Ebaluaziorako SoHO Batzordearen ebaluazio teknikoarekin. Prozesu horri esker, Mikrobiomik da giza jatorriko substantzietarako esparru arautzaile berria arrakastaz gainditu duen Europako lehen erakundea.<\/p>\n

\n

Osasun-inpaktua eta etorkizunerako proiekzioa<\/strong><\/h3>\n

ICD da herrialde garatuetan antibiotikoekin lotutako beherakoaren kausa nagusia, 100.000 biztanleko 171 kasuko intzidentziarekin Espainian, eta 32,1 milioi euroko urteko kostu zenbatetsia du Osasun Sistema Nazionalarentzat.<\/p>\n

EUTEGRAk (MBK 01), errepikapenak gutxitu, antibiotikoekiko mendekotasuna murriztu eta paziente zaurgarrien emaitza klinikoak hobetu ditzakeen kategoria terapeutiko berria inauguratu du.<\/p>\n

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Seed Capital Bizkaiaren konpromisoa berrikuntza bioteknologikoarekin<\/strong><\/h3>\n

Seed Capital Bizkaia, beraz, pozik agertu da Bizkaiko ekosistema ekintzaileak inpaktu globaleko soluzio terapeutikoak sortzeko duen ahalmena erakusten duen mugarri hori dela eta.<\/p>\n

Mikrobiomikek lortutako onarpen horrek, modu berean, indartu egiten du Bizkaiko Foru Aldundiak sektore estrategikoak eraldatzeko eta pertsonen bizi kalitatea hobetzeko gaitasuna duten proiektu berritzaileak babesteko duen xedea.<\/p>\n","protected":false},"excerpt":{"rendered":"

Mikrobiomik euskal biofarmazia enpresa 2018an sortu zen, Seed Capital Bizkaiaren partaidetzarekin, eta Europako SoHO Erregelamendu berriaren pean baimen bat lortu duen lehen konpainia europarra da….<\/p>\n","protected":false},"author":2,"featured_media":8065,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["post-8232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias-eu"],"yoast_head":"\nMikrobiomikek Europak mikrobiota garatuan oinarritutako lehen terapia biologikoari emandako onarpena ospatu du - Seed Capital Bizkaia<\/title>\n<meta name=\"description\" content=\"La empresa vasca Mikrobiomik lanzar\u00e1 la primera terapia basada en este tipo de microorganismos\u00a0en Espa\u00f1a en el segundo semestre de este a\u00f1o. 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