GEN, Alzheimer ve di\u011fer n\u00f6rodejeneratif hastal\u0131klar i\u00e7in geli\u015ftirilen SUL-238\u2019in Faz 1 klinik \u00e7al\u0131\u015fmas\u0131ndan elde edilen yeni olumlu sonu\u00e7lar\u0131 a\u00e7\u0131klad\u0131.<\/p>\n
Faz 1 sonu\u00e7lar\u0131, SUL-238\u2019in g\u00fcvenli, iyi tolere edilen, elveri\u015fli farmakokinetik profile sahip oldu\u011funu ve ya\u015fl\u0131 sa\u011fl\u0131kl\u0131 g\u00f6n\u00fcll\u00fclerde y\u00fcksek BOS penetrasyonu g\u00f6sterdi\u011fini ortaya koyuyor; bu bulgular Alzheimer ve di\u011fer n\u00f6rodejeneratif hastal\u0131klarda klinik geli\u015fimin bir sonraki a\u015famas\u0131n\u0131 destekliyor.<\/p>\n
GEN \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri A.\u015e. (GENIL.IS), T\u00fcrkiye\u2019nin \u00f6nde gelen uzmanla\u015fm\u0131\u015f ila\u00e7 \u015firketi, ilk-in-s\u0131n\u0131f, a\u011f\u0131zdan uygulanan, mitokondri hedefli yeni ila\u00e7 aday\u0131 SUL-238\u2019in ya\u015fl\u0131 sa\u011fl\u0131kl\u0131 g\u00f6n\u00fcll\u00fclerde g\u00fcvenlik, tolere edilebilirlik ve farmakokinetik (PK) \u00f6zelliklerini de\u011ferlendiren Faz 1 klinik \u00e7al\u0131\u015fmas\u0131na ili\u015fkin yeni olumlu sonu\u00e7lar\u0131 a\u00e7\u0131klad\u0131. Bulgular bug\u00fcn San Diego, Kaliforniya\u2019da d\u00fczenlenen 18. Alzheimer Hastal\u0131\u011f\u0131 Klinik \u00c7al\u0131\u015fmalar\u0131 Kongresi (CTAD) kapsam\u0131nda sunuldu.<\/p>\n
SUL-238 ba\u015flang\u0131\u00e7ta Sulfateq taraf\u0131ndan ke\u015ffedildi ve daha sonra Sulfateq ve GEN\u2019in ortak geli\u015ftirme \u00e7al\u0131\u015fmalar\u0131yla n\u00f6rodejeneratif hastal\u0131klara y\u00f6nelik yeni bir tedavi olarak daha da ileri ta\u015f\u0131nd\u0131.<\/p>\n
Bu Faz 1 randomize, \u00e7ift k\u00f6r, plasebo kontroll\u00fc \u00e7al\u0131\u015fma, \u00e7oklu artan dozlarda (MAD) a\u011f\u0131zdan uygulanan SUL-238\u2019in g\u00fcvenlili\u011fini, tolere edilebilirli\u011fini ve farmakokineti\u011fini \u226540 ya\u015f sa\u011fl\u0131kl\u0131 kad\u0131n ve erkek g\u00f6n\u00fcll\u00fclerde de\u011ferlendirdi. \u00c7al\u0131\u015fmada 14 g\u00fcnl\u00fck tedavi d\u00f6nemi ve dozlaman\u0131n ard\u0131ndan 14 g\u00fcnl\u00fck g\u00fcvenlilik takip s\u00fcresi olan iki kohort yer ald\u0131. Her bir kohorta 15 sa\u011fl\u0131kl\u0131 yeti\u015fkin 2:1 oran\u0131nda SUL-238 veya plasebo almak \u00fczere randomize edildi.<\/p>\n
Toplam g\u00fcnl\u00fck SUL-238 dozu: birinci kohortta 4000 mg (2000 mg g\u00fcnde iki kez), ikinci kohortta 4500 mg (1500 mg g\u00fcnde \u00fc\u00e7 kez) olarak uyguland\u0131. Her iki kohortta da SUL-238 \u00e7oklu dozlamada m\u00fckemmel bir g\u00fcvenlilik ve tolere edilebilirlik profili g\u00f6sterdi; ayr\u0131ca elveri\u015fli PK \u00f6zellikleri ve y\u00fcksek beyin omurilik s\u0131v\u0131s\u0131 (BOS) penetrasyonu sergileyerek Alzheimer ve Parkinson dahil n\u00f6rodejeneratif hastal\u0131klarda ileri klinik geli\u015fim i\u00e7in g\u00fc\u00e7l\u00fc bir aday oldu\u011funu ortaya koydu.<\/p>\n
Temel bulgular<\/p>\n
Her iki grupta g\u00fcvenlik:<\/p>\n
\tFiziksel ve n\u00f6rolojik muayenelerde, hayati bulgularda, EKG\u2019de ve klinik laboratuvar sonu\u00e7lar\u0131nda klinik a\u00e7\u0131dan anlaml\u0131 de\u011fi\u015fiklik g\u00f6zlenmedi.
\n\tYan etki (AE) oranlar\u0131 SUL-238 ve plasebo alan kat\u0131l\u0131mc\u0131lar aras\u0131nda benzerdi.
\n\tT\u00fcm yan etkiler hafif \u015fiddetteydi veya SUL-238 ile ili\u015fkili olmad\u0131\u011f\u0131 de\u011ferlendirildi.<\/p>\n
Birinci Gruptaki PK verileri (2000 mg b.i.d.):<\/p>\n
\tSUL-238 h\u0131zla emildi; maksimum plazma konsantrasyonuna (Tmax) ula\u015fma s\u00fcresi:
\n\t1.25\u00b10.54 saat (1. g\u00fcn), 1.50\u00b10.53 saat (14. g\u00fcn)
\n\tOrtalama terminal eliminasyon yar\u0131 \u00f6mr\u00fc (t1\/2):
\n\t3.50\u00b11.06 saat (14. g\u00fcn)
\n\tOrtalama \u00e7ukur plazma konsantrasyonu (Cmin):
\n\t39.23\u00b124.31 ng\/mL (8. g\u00fcn)
\n\t41.49\u00b118.20 ng\/mL (14. g\u00fcn)<\/p>\n
\u0130kinci Gruptaki PK verileri (1500 mg t.i.d.):<\/p>\n
\tTmax de\u011ferleri:
\n\t0.95\u00b10.16 saat (1. g\u00fcn), 1.00\u00b10.00 saat (14. g\u00fcn)
\n\tt1\/2:
\n\t3.74\u00b11.84 saat (14. g\u00fcn)
\n\tOrtalama \u00e7ukur plazma konsantrasyonu:
\n\t57.98\u00b131.08 ng\/mL (8. g\u00fcn)
\n\t60.63\u00b164.14 ng\/mL (14. g\u00fcn)<\/p>\n
GEN Y\u00f6netim Kurulu Ba\u015fkan\u0131 Abidin G\u00fclm\u00fc\u015f, \u201cSUL-238'in Faz 1 denememizde elde etti\u011fimiz bu yeni olumlu sonu\u00e7lar bizi b\u00fcy\u00fck \u00f6l\u00e7\u00fcde motive ediyor. Bu sonu\u00e7lar, Alzheimer hastal\u0131\u011f\u0131n\u0131n biyolojik temellerine y\u00f6nelik \u00f6nemli bir ilerlemeyi temsil ediyor.\u201d \u015feklinde konu\u015ftu.<\/p>\n
GEN Ar-Ge Ba\u015fkan Yard\u0131mc\u0131s\u0131 Dr. Nadir Ulu,\u00a0\u201cBu \u00c7oklu Artan Dozlu Faz 1 \u00e7al\u0131\u015fmas\u0131nda SUL-238\u2019in m\u00fckemmel g\u00fcvenlilik ve PK profili, onu Alzheimer dahil n\u00f6rodejeneratif hastal\u0131klardaki kritik kar\u015f\u0131lanmam\u0131\u015f ihtiya\u00e7lar\u0131 hedefleyen ileri klinik geli\u015ftirme i\u00e7in son derece g\u00fc\u00e7l\u00fc bir aday olarak konumland\u0131r\u0131yor.\u201d dedi.<\/p>\n
SUL-238 Hakk\u0131nda<\/p>\n
SUL-238, k\u0131\u015f uykusundan ilham al\u0131narak geli\u015ftirilmi\u015f, mitokondrileri hedefleyen k\u00fc\u00e7\u00fck molek\u00fcllerden olu\u015fan yeni bir terap\u00f6tik s\u0131n\u0131f\u0131n ilk temsilcisidir. Mitokondriyal biyogenezi destekler, kompleks I\/IV aktivasyonu yoluyla enerji \u00fcretimini optimize eder ve n\u00f6rodejeneratif, kardiyovask\u00fcler, renal hastal\u0131k modellerinde ve h\u0131zland\u0131r\u0131lm\u0131\u015f ya\u015flanma \u00e7al\u0131\u015fmalar\u0131nda mitokondri fonksiyonunu art\u0131r\u0131r. Kan-beyin bariyerini ge\u00e7ebilme yetene\u011fine sahiptir ve kapsaml\u0131 preklinik ile Faz 1 g\u00fcvenlilik \u00e7al\u0131\u015fmalar\u0131ndan ge\u00e7mi\u015ftir. GEN, SUL-238\u2019in n\u00f6rodejeneratif hastal\u0131klara y\u00f6nelik kullan\u0131m hakk\u0131n\u0131 Sulfateq B.V.\u2019den lisanslam\u0131\u015ft\u0131r.<\/p>\n
GEN Hakk\u0131nda<\/p>\n
1998 y\u0131l\u0131nda kurulan GEN, T\u00fcrkiye\u2019nin lider uzman ila\u00e7 \u015firketidir. \u00c7oklu terap\u00f6tik alanlarda yenilik\u00e7i tedaviler geli\u015ftirmeye odaklanan \u015firket, g\u00fc\u00e7l\u00fc Ar-Ge yat\u0131r\u0131mlar\u0131 ve k\u00fcresel i\u015f birlikleriyle d\u00fcnya \u00e7ap\u0131nda sa\u011fl\u0131k \u00e7\u00f6z\u00fcmlerini ileri ta\u015f\u0131maktad\u0131r. GMP sertifikal\u0131 \u00fcretim tesisinde y\u00fcksek kaliteli ve rekabet\u00e7i \u00fcr\u00fcnler geli\u015ftiren GEN, iki \u00f6zel Ar-Ge merkeziyle \u00f6zg\u00fcn ila\u00e7 geli\u015ftirme \u00e7al\u0131\u015fmalar\u0131n\u0131 s\u00fcrd\u00fcrmektedir.<\/p>\n
Sulfateq Hakk\u0131nda<\/p>\n
Sulfateq B.V., akademik ve end\u00fcstriyel ara\u015ft\u0131rma merkezleriyle stratejik i\u015f birlikleri y\u00fcr\u00fcterek yenilik\u00e7i ila\u00e7lar\u0131n erken geli\u015ftirilmesini h\u0131zland\u0131ran Hollanda merkezli bir biyoteknoloji \u015firketidir. \u015eirket, mitokondri sa\u011fl\u0131\u011f\u0131n\u0131 korumay\u0131 hedefleyen SUL bile\u015fik s\u0131n\u0131f\u0131n\u0131n geli\u015ftiricisidir.<\/p>\n
\u00a0<\/p>\n
<\/strong> GEN, Alzheimer ve di\u011fer n\u00f6rodejeneratif hastal\u0131klar i\u00e7in geli\u015ftirilen SUL-238\u2019in Faz 1 klinik \u00e7al\u0131\u015fmas\u0131ndan elde edilen yeni olumlu sonu\u00e7lar\u0131 a\u00e7\u0131klad\u0131.<\/p>\n","protected":false},"author":1,"featured_media":14697,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAow07ekDA:productID":"","footnotes":""},"categories":[4,10],"tags":[],"class_list":["post-14696","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dunya","category-otomobil"],"_links":{"self":[{"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/posts\/14696","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/comments?post=14696"}],"version-history":[{"count":0,"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/posts\/14696\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/media\/14697"}],"wp:attachment":[{"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/media?parent=14696"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/categories?post=14696"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ekonomigundemi.com.tr\/index.php\/wp-json\/wp\/v2\/tags?post=14696"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nSANAY\u0130 HABER AJANSI <\/p>\n","protected":false},"excerpt":{"rendered":"