Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Acute Kidney Injury (AKI)
Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Acute Kidney Injury (AKI)
Established animal model of AKI showed a statistically significant reduction of a key biomarker of kidney injury when treated with UNI-494
已建立的AKI動物模型顯示，使用UNI-494治療後，腎臟損傷的一個關鍵生物標誌物在統計學上顯著降低
AKI remains a serious unmet medical need with no FDA approved drugs for its treatment
AKI仍然是一種嚴重的未得到滿足的醫療需求，沒有FDA批准的治療藥物
On track to file regulatory submission by year end 2022 to initiate first-in-humans Phase 1 study with UNI-494
有望在2022年年底前提交監管文件，啟動UNI-494的首個人類階段研究
LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.
加利福尼亞州洛斯阿爾託斯，9月環球通訊社2022年7月7日--為腎臟疾病患者開發療法的臨牀階段生物技術公司Uncycive Treateutics，Inc.(納斯達克代碼：UNCY)今天宣佈，在急性腎損傷齧齒動物模型的臨牀前研究中，Uni-494療效的關鍵發現。
UNI-494 is a mitochondrial ATP sensitive potassium (mitoKATP) channel activator that is in development for the treatment of AKI. The Company evaluated the effect of UNI-494 on ischemia-reperfusion induced acute kidney injury (IR-AKI) in rats. Animals (n=10/group) were divided into 4 groups: sham, vehicle control, low dose of UNI-494 and high dose of UNI-494. Kidney injury was induced by 45-minute ischemia of bilateral kidneys. UNI-494 was administered orally 1-hour before the induction of ischemia and kidney function was monitored by measuring urinary creatinine, total urinary albumin, and β-2 microglobulin (β-2 MG). Treatment of animals with the higher dose of UNI-494 resulted in a statistically significant reduction of β-2 MG levels in urine.
UNI-494是一種線粒體ATP敏感鉀(mitoKATP)正在開發的用於治療AKI的通道激活劑。該公司評估了Uni-494對大鼠缺血再灌注性急性腎損傷(IR-AKI)的影響。每組動物10只，隨機分為4組：假手術組、空白對照組、UNI-494小劑量組和UNI-494大劑量組。大鼠雙側腎缺血45min造成腎臟損傷。缺血前1h口服UNI-494，測定尿肌酐、總白蛋白和β-2微球蛋白(β-2 MG)，監測腎功能。用較大劑量的UNI-494治療動物後，尿液中β-2微球蛋白水平在統計學上顯著降低。
"We are excited to report this key finding from the IR-AKI model showing treatment with UNI-494 significantly reduced this key biomarker of kidney injury that is a well-accepted biomarker of proximal renal tubule damage. We look forward to presenting these data, along with other data from the study, at an upcoming scientific meeting," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "We remain on track to file a regulatory submission by the end of 2022 that will allow us to initiate our Phase 1 study with UNI-494."
Unicycive首席執行官Shalabh Gupta醫學博士説：“我們很高興報告IR-AKI模型的這一關鍵發現，表明Uni-494的治療大大減少了腎臟損傷的這一關鍵生物標記，它是近端腎小管損傷的一個被廣泛接受的生物標記。我們期待着在即將舉行的一次科學會議上公佈這些數據以及這項研究的其他數據。”我們仍在按部就班地在2022年底之前提交監管文件，這將使我們能夠啟動我們對UNI-494的第一階段研究。
"These are very encouraging results for UNI-494. The rat IR-AKI model is a widely published model of AKI and β-2 MG is an established clinical biomarker of proximal renal tubule damage in AKI. The ability of UNI-494 to significantly reduce β-2 MG in these animals provides compelling support for the clinical development of this new drug for AKI," said Ravi Mehta, M.D., Prof. Emeritus of Medicine at University of California San Diego School of Medicine, and a world-renowned expert in AKI research.
醫學博士、加州大學聖地亞哥醫學院榮休教授、急性腎損傷研究方面的世界知名專家拉維·梅塔説：“這些對UNI-494來説是非常令人鼓舞的結果。大鼠IR-AKI模型是急性腎損傷的廣泛發表的模型，而β-2 MG是急性腎損傷近端腎小管損傷的臨牀生物標記物。UNI-494顯著降低這些動物的β-2 MG的能力為這種治療急性腎損傷的新藥的臨牀開發提供了強有力的支持。”
About UNI-494
關於UNI-494
UNI-494 is a novel proprietary drug that selectively binds to the SUR2B subunit of the mitochondrial KATP channel and activates it to restore mitochondrial function and reduce oxidative stress. UNI-494 is cleaved by esterase enzymes to form nicorandil which is the active metabolite. Nicorandil has extensive safety and efficacy data from multiple clinical trials including a 5,000-patient randomized controlled trial (IONA Study) and there is a consensus in the literature that the activation of mitoKATP channel is the biological basis for the observed cardio-protection and reno-protection in multiple clinical trials.
UNI-494是一種新型的專利藥物，它選擇性地與線粒體K的SUR2B亞單位結合ATP通道，並激活它，以恢復線粒體功能，減少氧化應激。UNI-494被酯酶裂解，生成活性代謝物尼可地爾。尼可地爾擁有來自多個臨牀試驗的廣泛的安全性和有效性數據，包括一項5000名患者參加的隨機對照試驗(IONA研究)，文獻中已達成共識，即激活mitoKATP在多個臨牀試驗中，通道是觀察到的心臟保護和腎臟保護的生物學基礎。
Unicycive has completed pharmacokinetic, safety pharmacology, genetic toxicity and ADME studies on UNI-494. Repeat dose toxicity studies in two species are on track to be completed in the third quarter. The Company is on track to file a regulatory submission in the second half of 2022 to initiate the Phase I healthy volunteer study.
Uncycive已經完成了對Uni-494的藥代動力學、安全藥理學、遺傳毒性和ADME研究。對兩個物種的重複劑量毒性研究正在進行中，預計將於第三季度完成。該公司有望在2022年下半年提交監管文件，啟動第一階段健康志願者研究。
While Unicycive's initial focus is on acute kidney injury (AKI), UNI-494's novel mechanism of action may also hold promise for indications in which mitochondrial dysfunction is implicated such as chronic kidney disease, liver disease (alcoholic hepatitis, hepatic encephalopathy) and ophthalmic disease (dry AMD, macular degeneration, etc).
雖然Unicycive最初的重點是急性腎臟損傷(AKI)，但Uni-494的新作用機制也可能適用於涉及線粒體功能障礙的適應症，如慢性腎臟疾病、肝病(酒精性肝炎、肝性腦病)和眼科疾病(乾性AMD、黃斑變性等)。
UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.
UNI-494受到美國和歐洲頒發的專利以及全球範圍內廣泛專利申請的保護。
About Unicycive Therapeutics
關於單細胞治療學
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit .
Uncycive Treateutics是一家開發腎臟疾病新療法的生物技術公司。Uncycive的先導藥物Renazorb是一種正在開發的用於治療高磷血癥的新型磷酸鹽結合劑。UNI-494是一種受專利保護的新化學實體，處於臨牀前開發的晚期，用於治療急性腎損傷。欲瞭解更多信息，請訪問。
Investor Contact:
投資者聯繫方式：
ir@unicycive.com
(650) 900-5470
郵箱：ir@unicycive.com
(650) 900-5470
Anne Marie Fields
Stern Investor Relations
annemarie.fields@sternir.com
212-362-1200
安妮·瑪麗·菲爾茲
斯特恩投資者關係
郵箱：annemarie.field@sternir.com
212-362-1200
SOURCE: Unicycive Therapeutics, Inc.
資料來源：Unicycive Treateutics，Inc.
譯文內容由第三人軟體翻譯。