Sirnaomics announced the completion of the Phase I clinical trial of the GalNAc RNAi therapeutic drug STP122G for anticoagulant therapy and released midterm data.

PR Newswire · Jul 8 14:40

香港、美國馬里蘭州德國城和蘇州2024年7月8日 /美通社/ -- Sirnaomics Ltd.（「公司」，連同其附屬公司，統稱「集團」或「Sirnaomics」；股份代號：2257），一家行業領先的專注於探索及開發RNAi療法的生物製藥公司），今日宣佈STP122G用於抗凝治療的I期臨床試驗第二序列圓滿完成，並公佈了中期數據。該療法產品為一種靶向十一因子的新型抗凝血療法。

第二序列組由8名健康受試者組成。受試者通過皮下注射完成了50毫克的劑量的注射，並接受了140天的隨訪。安全數據顯示，劑量限制性毒性或嚴重不良事件沒有出現，同時觀察到了與劑量相關的靶點沉默活性。故此本次臨床研究將推進進入下一序列劑量組。Sirnaomics預計為本次臨床試驗招募多達5個劑量遞增序列組。本項I期、多中心、隨機、雙盲、序列分組研究旨在評估STP122G為健康受試者進行皮下注射單次遞增劑量的安全性、耐受性和藥代藥動。本次臨床試驗將比較五種不同劑量的STP122G（25 mg、50 mg、100 mg、200 mg、400 mg）的安全性及耐受性，以為未來的研究選擇最佳劑量。此外，還將對目標沉默活性和治療效果進行測量和比較，以進行劑量依賴性評估。本次臨床研究計劃招募40名受試者。

Sirnaomics創始人、董事會主席、執行董事、總裁兼首席執行官陸陽博士表示：「STP122G是首個基於集團GalAhead mxRNA技術，靶向十一因子的抗凝治療候選藥物。STP122G可用於預防深靜脈栓塞、心房顫動治療預防腦卒中，及治療肺栓塞等多種疾病，這種新型抗凝療法將使患者受益匪淺。對前兩個序列共16名健康參與者進行的臨床研究表明，該藥物具有極佳的安全性和劑量依賴的十一因子靶點沉默活性。」

STP122G為第三代十一因子抗凝血藥物，適用於先前的治療不能完全防止出血情況的凝血障礙患者。十一因子是一種主要由肝臟內的肝細胞所產生的酶，其於人體凝血過程中發揮著重要作用。透過抑制十一因子，STP122G可能比現有的抗凝血藥物具有更好的安全性。目前有三類十一因子抑制劑已經處於市場化或臨床試驗階段，包括：RNA療法產品、小分子療法產品及單克隆抗體療法產品。作為一種基於Sirnaomics的GalAhead mxRNA遞送平台的RNA療法候選藥物，STP122G以肝細胞為靶點，抑制十一因子的產生，具有長期療效及較小的出血風險。

如欲了解有關本次臨床試驗的其他相關資訊，請瀏覽clinicaltrials.gov，識別碼：NCT05844293。

關於STP122G

STP122G為Sirnaomics領先的GalAhead mxRNA十一因子療法項目候選藥物。作為集團十一因子治療項目的一部分，Sirnaomics已於2023年3月為STP122G向美國食品藥物管理局提交了IND申請，並於2023年4月啟動了其I期臨床試驗。集團於2024年1月啟動了第二序列研究，結果顯示，該研究具有極佳的安全性和劑量依賴的十一因子靶點沉默活性。該項目適用於廣泛的疾病適應症，如預防心房顫動、治療心房顫動導致的中風及免疫治療後的癌症患者、以及改善全膝關節置換恢復。STP122G為首個採用Sirnaomics專有的GalNAc RNAi遞送平台GalAhead的候選藥物。

關於Sirnaomics

Sirnaomics是一家RNA療法生物製藥公司，公司候選產品處於臨床及臨床前階段，專注於探索及開發創新藥物，用於治療具有醫療需求及龐大市場機會的適應症。Sirnaomics是首家於亞洲和美國均擁有重要市場地位的臨床階段RNA 療法生物製藥公司。憑藉其專有的遞送技術：多肽納米顆粒遞送平台和第二代GalNAc偶聯物遞送平台，本集團已建立非常豐富的候選藥物管線。隨著公司STP705和STP707的臨床項目取得多項成功，Sirnaomics目前在推進腫瘤治療的RNAi藥物方面處於國際領先地位。STP122G是首款進入臨床研發階段的 GalAhead技術候選藥物。隨著集團臨床項目的擴大和集團生產設施的建立，Sirnaomics仍致力於從生物技術公司向生物製藥公司轉型。如欲了解更多關於公司資訊，可瀏覽：。

On July 8, 2024, in Maryland, USA, Germany City and Suzhou / PRNewswire / - Sirnaomics Ltd.("Company", together with its subsidiaries referred to as the "group" or "Sirnaomics"; stock code: 2257), a leading biopharmaceutical company focusing on exploring and developing RNAi therapies, announced today that STP122G, a new anticoagulant therapy targeting factor XI, used in anticoagulant therapy, has successfully completed the second sequence of phase I clinical trials and released midterm data. The therapeutic product targets factor XI and is a new type of anticoagulant therapy.The second sequence group consisted of 8 healthy subjects. The subjects completed injections of 50 milligrams by subcutaneous injection and were followed up for 140 days. Safety data showed no dose-limiting toxicity or serious adverse events, while dose-dependent target silencing activity was observed. Therefore, this clinical study will advance to the next sequence of dose groups. Sirnaomics plans to recruit up to 5 dose escalation groups for this clinical trial. This phase I, multicenter, randomized, double-blind, sequence-grouped study aims to evaluate the safety, tolerability, and pharmacodynamics of STP122G in healthy volunteers receiving single-dose subcutaneous injection escalation. The clinical trial compares the safety and tolerability of five different doses of STP122G (25 mg, 50 mg, 100 mg, 200 mg, 400 mg) and selects the best dose for future studies. In addition, measurement and comparison of target silencing activity and therapeutic effects will be conducted to evaluate dose dependence. This clinical trial plans to enroll 40 participants. Dr. Patrick Lu, founder, Board Chairman, Executive Director, President and CEO of Sirnaomics said, 'STP122G is the first anticoagulant drug candidate targeting factor XI based on the group's GalAhead mxRNA technology. STP122G can be used to prevent deep vein thrombosis, treat atrial fibrillation to prevent stroke, and treat pulmonary embolism and other diseases. This new anticoagulant therapy will greatly benefit patients. The clinical trial conducted on 16 healthy participants in the first two sequences showed that the drug has excellent safety and dose-dependent target silencing activity.' STP122G is a third-generation factor XI anticoagulant drug suitable for coagulation disorders patients whose previous treatment cannot fully prevent bleeding. Factor XI is an enzyme mainly produced by hepatocytes in the liver, and plays an important role in the human coagulation process. By inhibiting factor XI, STP122G may have better safety than existing anticoagulant drugs. There are currently three types of factor XI inhibitors in market or clinical stages, including RNA therapy products, small molecule therapy products, and monoclonal antibody therapy products. As an RNA therapy candidate drug based on Sirnaomics' GalAhead mxRNA delivery platform, STP122G targets hepatocytes to inhibit the production of factor XI, and has long-term efficacy and lower bleeding risk.

For more information about this clinical trial, please visit clinicaltrials.gov, Identifier: NCT05844293.

Sirnaomics' founder, Board Chairman, Executive Director, President and CEO Dr. Patrick Lu said, 'STP122G is the first anticoagulant drug candidate targeting factor XI based on the group's GalAhead mxRNA technology. STP122G can be used to prevent deep vein thrombosis, treat atrial fibrillation to prevent stroke, and treat pulmonary embolism and other diseases. This new anticoagulant therapy will greatly benefit patients.' STP122G is the first anticoagulant drug candidate targeting factor XI based on the group's GalAhead mxRNA technology. STP122G can be used to prevent deep vein thrombosis, treat atrial fibrillation to prevent stroke, and treat pulmonary embolism and other diseases. This new anticoagulant therapy will greatly benefit patients.

Sirnaomics submitted an IND application for STP122G to the US Food and Drug Administration in March 2023 as part of the group's factor XI therapy project. The phase I clinical trial was launched in April 2023. The second sequence study was launched in January 2024, and the study demonstrated excellent safety and dose-dependent factor XI target silencing activity. The project is suitable for a wide range of indications, such as preventing atrial fibrillation, treating stroke caused by atrial fibrillation, immunotherapy for cancer patients after treatment, and improving recovery after total knee arthroplasty. STP122G is the first candidate drug using Sirnaomics' proprietary GalNAc RNAi delivery platform GalAhead to target hepatocytes and inhibit factor XI production.

About STP122G

STP122G is a leading GalAhead mxRNA factor XI therapy candidate drug from Sirnaomics. As part of the group's factor XI therapy project, Sirnaomics submitted an IND application for STP122G to the US Food and Drug Administration in March 2023, and launched its phase I clinical trial in April 2023. In January 2024, the group launched the second sequence study, and the study demonstrated excellent safety and dose-dependent factor XI target silencing activity. The project is suitable for a wide range of indications, such as preventing atrial fibrillation, treating stroke caused by atrial fibrillation, immunotherapy for cancer patients after treatment, and improving recovery after total knee arthroplasty. STP122G is the first candidate drug using Sirnaomics' proprietary GalNAc RNAi delivery platform GalAhead to target hepatocytes and inhibit factor XI production. About Sirnaomics

Sirnaomics Ltd. (2257.HK) is a leading biopharmaceutical company focusing on exploring and developing RNAi therapies.

About STP122GSirnaomics Ltd. (2257.HK) is a leading biopharmaceutical company focusing on exploring and developing RNAi therapies.

Sirnaomics is an RNA therapy biopharmaceutical company. The company's candidate products are in clinical and preclinical stages, focusing on exploring and developing innovative drugs for the treatment of indications with medical needs and huge market opportunities. Sirnaomics is the first clinical-stage RNA therapy biopharmaceutical company with important market positions in both Asia and the United States. With its proprietary delivery technologies, peptide nanoparticle delivery platform and second-generation GalNAc conjugate delivery platform, the group has established a very rich pipeline of candidate drugs. With the success of the company's clinical projects STP705 and STP707, Sirnaomics is currently in an international leading position in promoting RNAi drugs for cancer treatment. STP122G is the first GalAhead technology candidate drug to enter clinical development stage. As the group's clinical projects expand and the group's production facilities are established, Sirnaomics is still committed to transforming from a biotechnology company to a biopharmaceutical company. For more information about the company, please visit:.

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Sirnaomics宣佈基於GalNAc RNAi療法藥物STP122G用於抗凝治療的I期臨床試驗第二序列圓滿完成並公佈了中期數據

Sirnaomics announced the completion of the Phase I clinical trial of the GalNAc RNAi therapeutic drug STP122G for anticoagulant therapy and released midterm data.

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