EX-99.1 2 exhibit991-jixingdataannou.htm EX-99.1 Document
第99.1展示文本
    
corxellogo.jpg
lenzlogo.jpg
    

CORXEL和LENZ Therapeutics宣佈LNZ100中國第3期老視眼前試驗積極的頭條數據
主要終點在治療後3小時,有74%接受LNZ100劑量的參與者實現了3條線或更高水平的改善並保持視力的最佳距離(即不喪失5個或更多字母)。與對照組相比,LNZ100治療組的療效差異在統計上具有顯著性(p<0.0001)
快速起效和持續時間長,69%的參與者在30分鐘時實現了三行或更大的改善,10小時時爲30%
91%的參與者表示他們注意到了他們近視的改善
LNZ100有可能成爲老視遠視症最佳的非侵入性治療方法
2024年10月27日,上海、中國和加利福尼亞聖地亞哥 – Corxel Pharmaceuticals(CORXEL)和LENZ Therapeutics(納斯達克:LENZ)今天宣佈,LNZ100在中國老花眼患者中進行的第三階段JX07001臨床試驗取得了積極的頭孢素數據。CORXEL是一家領先的生物技術公司,致力於爲患有嚴重和危及生命疾病的患者帶來創新的科學和藥物。LENZ Therapeutics是一家面向未上市的生物製藥公司,專注於開發第一款也是唯一一款基於乙膽鹼的眼用滴劑,以改善老花眼患者的近視。
在這項中國第3期安全性和有效性試驗中,LNZ100(1.75% 乙膽鹼鹽酸鹽)實現了主要終點和關鍵次要終點,在近距離處以統計學顯著的方式實現了三行或更多的最佳矯正距離視力(BCDVA)改善,並保持了他們的最佳遠距視力(即,不失去5個或更多字母)。更多結果顯示(所有p<0.0001):
快速發作:84%和69%分別在30分鐘時實現了兩行和三行或更多的改善。
治療後3小時:88% 和 74% 分別在3小時內達到二線和三線或更大程度的改善並保持了他們的最佳距離視力(即沒有丟失5個或更多字母)
持久時間:61%和30%分別在10小時時實現了兩行和三行或更多的改善。
LNZ100在試驗中表現良好,未觀察到嚴重的與治療相關的不良事件。
這項研究是一個第3階段、多中心、隨機、雙盲、車輛對照研究,包括一個爲期4周的有效性研究,後續爲5個月的延伸安全性研究,旨在評估LNZ100(一種基於鹽酸艾斯膽鹼的眼藥水)對老視患者的療效和安全性。研究目標是評估LNZ100改善中國老視患者近視能力的潛力,並評估其療效和安全性特性。該試驗共招募了300名參與者,招募標準廣泛,年齡區間在45到75歲之間,屈光範圍爲-4.0D SE至+1.0D SE,包括那些接受過激光助視角膜屈光手術/單焦點人工晶體眼內鏡植入術的患者。
賈區教授,主要研究員和聯合主要研究員中國醫學會眼科分會副主任,溫州醫科大學驗光科主任表示:“我們對LNZ100試驗結果非常滿意,特別是LNZ100在老視眼病患者中顯示出顯著的療效和良好的安全性,這在老視眼病治療領域取得了重要進展。目前,患者主要依賴佩戴眼鏡作爲老視眼病的治療方法。非侵入性和



可逆治療。我們期待LNZ100將填補這一空白,在中國成爲治療老花眼的創新力量,爲更多患者帶來清晰視力的希望。
樊柳教授,主要研究員和聯合主要研究員中國醫學會眼科醫療分會驗光學工作組負責人,國家眼科疾病臨床醫學研究中心董事稱「LNZ100的主要活性成分乙胺膽鹼使瞳孔暫時收縮,產生明顯延長焦點深度和改善視力的光學效果。試驗中觀察到的具有統計學意義的數據和臨床意義明顯的結局,爲LNZ100的有效性和安全性提供了有力支持。我們預期,LNZ100將是一種實用的治療選擇,適用於廣泛範圍的患者,並將有助於幫助改善中國老視人群的近視,從而產生有利影響。」
「我們特別感謝所有辛勤工作、專注研究的研究人員、合作伙伴組織以及參與研究的所有志願者。」 CORXEL的董事兼首席執行官Sandy Mou表示,「我們的共同目標是造福全球數億人民,樹立國際領先的研究標杆,引入新穎的治療理念和潛在優質產品首先在中國,爲大量老花病患提供安全便捷的治療選擇。展望未來,我們將積極與藥物監管機構溝通合作,加快LNZ100的提交和批准。我們相信LNZ100不僅將顯著改善患者的視力和生活質量,還將對中國老花病治療和研究領域產生深遠影響。」
「我們首先要祝賀CORXEL團隊在中國的第3期臨床研究中的努力。我們對LNZ100在我們的集體研究中所展示出的令人印象深刻和一致的表現感到高興,進一步驗證了定位爲「全天候全天候」解決方案願景,」LENZ Therapeutics總裁兼首席執行官Eef Schimmelpennink說道。「憑藉這些數據,我們相信LNZ100進一步提升了作爲全球療法的潛力,並正朝着爲中國估計的40000萬近視人群提供幫助的道路上邁進。這些數據意味着CORXEL和LENZ團隊之間巨大的共同努力,並且緊隨最近美國FDA接受我們針對LNZ100的新藥申請的腳步。」
關於老視
老花眼是與年齡有關的生理現象,導致看近處物體清晰度逐漸下降。這是由晶狀體逐漸變硬引起的。這導致眼睛調節功能下降,無法將近物體的圖像聚焦到視網膜上,從而導致近視力下降。研究表明,老花眼的發病年齡通常在38歲左右,到了52歲時在中國的患病率接近100%。據估計,中國有超過40000萬患者患有老花眼。
目前,老視遠的治療期權非常有限。戴眼鏡需要頻繁摘戴,給工作和生活帶來諸多不便。手術作爲一種不可逆的侵入性操作,被接受度非常有限。中國尚未批准任何藥物用於老視遠的醫療,對於非侵入性、安全、高效、可逆的老視遠治療的醫療需求仍未得到解決。
關於 LNZ100
LNZ100(乙色胺)眼用滴劑由LENZ Therapeutics公司開發,CORXEL於2022年4月獲得了在大中華地區進行開發和商業化的權利。 LNZ100採用乙色胺為配方,乙色胺是一種瞳孔收縮劑,旨在實現最佳瞳孔直徑而不影響視距。



vision, a key limitation of other miotics. Miotics are compounds that cause pupil constriction, or miosis, creating a pinhole effect that enables better focus of incoming light from near objects onto the retina. Research has shown that a pupil diameter below two millimeters (2 mm) is optimal for presbyopia treatment and results in clinically meaningful improvement in near vision.
Unlike other miotics such as pilocarpine and carbachol, aceclidine’s mechanism of action is pupil-selective, meaning it can activate the iris sphincter muscle and cause miosis of the pupil to a diameter below 2 mm without overstimulating the ciliary muscles that can cause a myopic shift and impair distance vision. As a result, aceclidine does not require any remaining accommodation to improve near vision, broadening its benefits to older presbyopes whose lens has lost this capacity. Therefore, we expect that users may be able to benefit from treatment even as they age from mid-40s to well into their mid-70s and across a broad range of refractive errors, as demonstrated in clinical testing to date.
About CORXEL
CORXEL, formerly named Ji Xing Pharmaceuticals, is a leading biotech company headquartered in US and China committed to bringing innovative science and medicines to underserved patients with serious and life-threatening cardiometabolic diseases. Backed by RTW Investments, CORXEL was founded in 2019 to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in diseases. With a strong and further developing asset pipeline, industry leading talent, and patient-centric focus, CORXEL is dedicated to deliver a meaningful and lasting impact on patients.
The full portfolio of CORXEL consists of 2 assets with global rights and 4 assets with Greater China rights in late-stage clinical development. The portfolio with global rights are JX09 for hypertension and JX10 for acute ischemic stroke (AIS), while the portfolio with Greater China rights include aficamten, etripamil, varenicline solution nasal spray/US brand name TYRVAYA®, and LNZ100.
For further information about CORXEL, please visit www.corxelbio.com.
About LENZ Therapeutics
LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate, LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of United States federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of LNZ100 to have best-in-class performance and LNZ100 as a global therapy; the size of the addressable population for LNZ100; expectations regarding the commercial opportunity and beneficial characteristics of LNZ100; and plans and expectations regarding commercialization of



LNZ100, if approved. These statements are based on numerous assumptions concerning the development of LENZ’s products and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in LENZ’s Quarterly Report on Form 10-Q filed for the quarter ended June 30, 2024 and in LENZ’s subsequent filings with the SEC. LENZ cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

LENZ Therapeutics Contact:
Dan Chevallard
IR@LENZ-Tx.com