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Kiora Pharmaceuticals Receives Grant From Choroideremia Research Foundation to Fund Novel Clinical Trial Endpoints for Inherited Retinal Diseases; Approval Granted to Initiate Clinical Validation Study

Kiora Pharmaceuticals Receives Grant From Choroideremia Research Foundation to Fund Novel Clinical Trial Endpoints for Inherited Retinal Diseases; Approval Granted to Initiate Clinical Validation Study

Kiora Pharmicals 獲得脈絡膜血癥研究基金會的資助,用於資助遺傳性視網膜疾病的新臨床試驗終點;獲准啓動臨床驗證研究
newsfile ·  04/11 19:00

Encinitas, California--(Newsfile Corp. - April 11, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) has received grant funding from the Choroideremia Research Foundation (CRF) in support of validating functional vision assessments for patients with profound blindness. Functional vision assessments are task-oriented challenges designed to mimic real-world environments. Importantly, functional vision assessments have served as approvable endpoints in registration/marketing authorization studies by worldwide regulators. This grant support will aid in funding further validation of the Multiluminence Orientation & Mobility (MLOMTM) suite of tests, designed and developed in partnership with Ora, Inc., enabling their use in Kiora's upcoming ABACUS-2 Phase 2 clinical trial assessing KIO-301. ABACUS-2 is a randomized, controlled trial investigating KIO-301 for vision restoration in patients with late-stage retinitis pigmentosa; and if successful, could serve to restore vision in patients with choroideremia and other inherited retinal diseases (IRDs).

加利福尼亞州恩西尼塔斯--(Newsfile Corp.,2024年4月11日)——Kiora Pharmicals, Inc.(納斯達克股票代碼:KPRX)已獲得Choroideremia 研究基金會(CRF)的撥款,以支持驗證深度失明患者的功能性視力評估。功能視覺評估是以任務爲導向的挑戰,旨在模仿現實世界的環境。重要的是,功能視覺評估已成爲全球監管機構註冊/上市授權研究中批准的終點。這項撥款支持將有助於爲進一步驗證多發光定向與機動性(MLOM)提供資金TM) 與 Ora, Inc. 合作設計和開發的一系列測試,使其能夠用於基奧拉即將進行的評估 KIO-301 的 ABACUS-2 2 期臨床試驗。ABACUS-2 是一項隨機對照試驗,研究 KIO-301 對晚期色素性視網膜炎患者的視力恢復;如果成功,可以用於恢復脈絡膜血癥和其他遺傳性視網膜疾病 (IRD) 患者的視力。

Approval for the clinical validation study was recently granted. The validation work can now begin shortly and will be performed in collaboration with Professor Robert Casson, MBBS (Hons), M.Biostat, DPhil, FRANZCO, consultant ophthalmologist at the Royal Adelaide Hospital and hHad of Ophthalmology and Visual Science at Adelaide University. The goal is to work with IRD patients to refine and validate specific endpoints to objectively and reliably measure functional vision changes, providing a standard and acceptable assessment for global regulatory bodies.

該臨床驗證研究最近獲得批准。驗證工作現在可以很快開始,並將與羅伯特·卡森教授、MBBS(榮譽學位)、M.Biostat、DPhil、FRANZCO、皇家阿德萊德醫院眼科顧問醫生和阿德萊德大學眼科和視覺科學系主任合作進行。目標是與IRD患者合作,完善和驗證特定的終點,以客觀可靠地測量功能性視力的變化,爲全球監管機構提供標準和可接受的評估。

"Our patient community is encouraged by the new technologies and treatments under development for Choroideremia," said Kathi Wagner, Executive Director of the CRF. "Importantly, we also recognize that rigorous, standardized assessments of vision correlating to improvements in everyday life are required to bring these treatments to the marketplace. The CRF's contribution under this grant will help ensure appropriate tests are available for all drug developers. This grant is ultimately about providing greater clarity on the pathway to approvability."

CRF執行董事凱西·瓦格納說:“正在開發的脈絡膜血癥新技術和治療方法令我們的患者社區感到鼓舞。”“重要的是,我們還認識到,要將這些治療方法推向市場,需要對與日常生活改善相關的視力進行嚴格、標準化的評估。CRF在這筆補助金下的捐款將有助於確保所有藥物開發商都能獲得適當的測試。這筆撥款最終旨在進一步明確獲得批准的途徑。”

This validation work will build upon learnings from Kiora's ABACUS-1 trial, a feasibility study assessing safety and efficacy of its investigational drug, KIO-301. With feedback from Kiora's pre-IND meeting with the US FDA, Kiora and Ora will validate the latest generation of functional endpoints. According to Keith Lane, Vice President, Posterior Segment of Ora, Inc., "We are thrilled to play this important role in developing vision restoring therapies to those most in need and look forward to having the MLOM tests front and center for next generation therapies." The validation work will be performed in Australia as part of an extension to ABACUS-1.

這項驗證工作將建立在 Kiora 的 ABACUS-1 試驗的經驗基礎上,該試驗是一項評估其在研藥物 KIO-301 安全性和有效性的可行性研究。根據Kiora與美國食品藥品管理局的IND前會議的反饋,Kiora和Ora將驗證最新一代的功能終端。Ora, Inc. 後部副總裁基思·萊恩表示:“我們很高興在爲最需要的人開發視力恢復療法方面發揮這一重要作用,並期待將MLOM測試作爲下一代療法的重中之重。”作爲 ABACUS-1 擴展的一部分,驗證工作將在澳大利亞進行。

"We want to thank the CRF for their financial support and entrusting us with taking on this important work," added Eric Daniels, MD, MBA, Chief Development Officer of Kiora. "As we look to advance KIO-301 through clinical development across multiple IRDs, including choroideremia, input from regulators, physicians, and ultimately patients is essential in helping shape the pathway to market for not only our drug, but for therapies potentially benefiting the entire community."

Kiora首席開發官醫學博士、工商管理碩士埃裏克·丹尼爾斯補充說:“我們要感謝CRF的財政支持,並委託我們承擔這項重要工作。”“當我們希望通過包括脈絡膜血癥在內的多個IRD的臨床開發來推動 KIO-301 的發展時,監管機構、醫生乃至患者的意見對於塑造我們的藥物以及可能使整個社區受益的療法的上市路徑至關重要。”

About Kiora Pharmaceuticals

關於 Kiora 製藥

Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of posterior non-infectious uveitis. It is a next-generation, non-steroidal, immuno-modulatory, and small molecule inhibitor of dihydroorotate dehydrogenase.

Kiora Pharmaceuticals是一家臨床階段的生物技術公司,正在開發和商業化治療孤兒視網膜疾病的產品。KIO-301 正在開發用於治療色素性視網膜炎、脈絡膜血癥和斯塔加特病。它是一種分子光電開關,有可能恢復遺傳性和/或年齡相關性視網膜變性患者的視力。KIO-104 正在開發用於治療後部非感染性葡萄膜炎。它是二氫乳清酸脫氫酶的下一代非甾體免疫調節小分子抑制劑。

In addition to news releases and SEC filings, we expect to post information on our website () and social media accounts that could be relevant to investors. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts.

除了新聞稿和美國證券交易委員會文件外,我們還希望在我們的網站 () 和社交媒體賬戶上發佈可能與投資者相關的信息。我們鼓勵投資者在推特和領英上關注我們,訪問我們的網站和/或訂閱電子郵件提醒。

Forward-Looking Statements

前瞻性陳述

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-301 and KIO-104, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the ability of KIO-301 to improve visual function, the potential to expand KIO-301 to other indications including choroideremia and Stargardt disease, and the planned design of the Phase 2 clinical trial for KIO-301. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, the ability to obtain any required regulatory approvals, whether future trials of KIO-301 will yield similar results for participants, market and other conditions, and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2024, or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.

本新聞稿中的一些聲明是 “前瞻性的”,是根據1995年《私人證券訴訟改革法》的安全港條款作出的。這些 “前瞻性” 陳述除其他外包括與 Kiora 開發階段產品(包括 KIO-301 和 KIO-104)相關的開發和商業化工作以及其他監管或市場批准工作,以及這些產品的成功(此類批准或成功可能無法及時獲得或實現)、KIO-301 改善視覺功能的能力、將 KIO-301 擴展到其他適應症的可能性,包括脈絡膜血癥和 Stargargargardargars 在內的其他適應症的可能性等。DT病,以及該病的計劃設計KIO-301 的 2 期臨床試驗。這些聲明涉及風險和不確定性,可能導致結果與本新聞稿中列出的聲明存在重大差異,包括及時進行臨床試驗的能力、獲得任何必要的監管批准的能力、未來的 KIO-301 試驗是否會對參與者產生類似結果、市場和其他條件,以及Kiora向美國證券交易委員會提交的10-K表年度報告中在 “風險因素” 標題下描述的某些風險因素 2024 年 3 月 25 日,或描述於基奧拉的其他公開文件。Kiora的業績還可能受到Kiora目前尚未意識到的因素的影響。本新聞稿中的前瞻性陳述僅代表截至本新聞稿發佈之日。除非法律要求,否則Kiora明確表示不承擔任何義務或承諾公開發布此類聲明的任何更新或修訂,以反映其對該聲明的期望的任何變化或任何此類聲明所依據的事件、條件或情況的任何變化。

Contacts:

聯繫人:

Investors
investors@kiorapharma.com

投資者
investors@kiorapharma.com

Media
kiora@crowepr.com
Crowe PR

媒體
kiora@crowepr.com
Crowe PR

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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