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Codexis and Nestlé Health Science Initiate a Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency

Codexis and Nestlé Health Science Initiate a Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency

Codexis和雀巢健康科學公司啟動CDX-7108治療胰腺外分泌功能不全的一期臨牀試驗
GlobeNewswire ·  2021/11/04 04:30

REDWOOD CITY, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading protein engineering company and developer of novel biotherapeutics, and Nestlé Health Science, a globally recognized leader in the field of nutritional science, announced today the dosing of the first subject in a Phase 1 study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108.

亞洲網加利福尼亞州雷德伍德城11月3日電領先的蛋白質工程公司和新型生物療法的開發商Codexis公司(納斯達克市場代碼:CDXS)和全球公認的營養科學領域領先者雀巢健康科學公司今天宣佈,CDX-7108的安全性、耐受性、藥代動力學(PK)和藥效學的第一階段研究的第一個受試者開始配藥。

CDX-7108 is a lipase variant specifically engineered to overcome the limitations of traditional pancreatic enzyme replacement therapy (PERT) deficiencies. PERT is the main treatment for exocrine pancreatic insufficiency (EPI), a debilitating condition of the GI-tract that is caused by conditions that impair pancreatic function, such as pancreatitis, pancreatic cancer, Crohn's disease, celiac disease, and cystic fibrosis. CDX-7108 was engineered to be highly stable to the acidic conditions in the stomach and resistant to proteases in the upper intestines.

CDX-7108是一種脂肪酶變種,專為克服傳統胰腺酶替代療法(PERT)缺陷而設計。PERT是外分泌胰腺功能不全(EPI)的主要治療方法,EPI是一種由損害胰腺功能的疾病引起的胃腸道衰弱狀況,如胰腺炎、胰腺癌、克羅恩病、乳糜瀉和囊性纖維化。CDX-7108被設計成對胃中的酸性條件高度穩定,並對上腸中的蛋白酶具有抵抗力。

The integrated, three-part Phase 1a/1b study comprises a randomized, double-blind, placebo-controlled dose escalation to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single (part A) and multiple (part B) oral dose administration in healthy adult subjects. Part C is a randomized, double-blind, placebo-controlled, single-dose, 2-way crossover study to assess proof-of-concept of CDX-7108 for pharmacodynamics, safety, tolerability, and immunogenicity in subjects with EPI.

這項由三部分組成的1a/1b期綜合研究包括一項隨機、雙盲、安慰劑對照劑量遞增試驗,目的是調查CDX-7108在健康成人受試者中單次(A部分)和多次(B部分)口服劑量後的安全性、耐受性、免疫原性和PK。C部分是一項隨機、雙盲、安慰劑對照、單劑量、雙向交叉研究,旨在評估CDX-7108在EPI受試者中的藥效學、安全性、耐受性和免疫原性的概念驗證。

"Our partnership with Nestlé Health Science aims at leveraging the CodeEvolver® protein engineering platform to create novel orally administered enzyme therapies for patients. We are excited to advance the first candidate from this partnership, CDX-7108, into clinical development", according to John Nicols, Codexis' President and CEO. "The complementarity of Nestlé Health Science's gastrointestinal experience and Codexis' proven ability to discover and develop differentiated enzymes, has led to the rapid advancement of CDX-7108 into the clinic", Gjalt Huisman, Senior Vice-President, Codexis Biotherapeutics added.

Codexis公司總裁兼首席執行官約翰·尼科爾斯説:“我們與雀巢健康科學公司的夥伴關係旨在利用CodeEvolver®蛋白質工程平臺為患者創造新的口服酶療法。我們很高興能從這一夥伴關係中推動第一個候選者CDX-7108進入臨牀開發。”Codexis生物治療公司高級副總裁Gjalt Huisman補充説:“雀巢健康科學公司的胃腸經驗與Codexis公司已被證明的發現和開發差異化酶的能力相輔相成,這使得CDX-7108迅速進入臨牀。”

"The goal of our strategic collaboration is to offer an effective new treatment for people who suffer from exocrine pancreatic insufficiency," said Hans-Juergen Woerle, Chief Scientific and Medical Officer at Nestlé Health Science. "The CDX-7108 program has advanced rapidly, discovering and developing this orally-administrable enzyme candidate for clinical development."

雀巢健康科學公司(NestléHealth Science)首席科學和醫療官漢斯-尤爾根·沃勒(Hans-Juergen Woerle)表示:“我們戰略合作的目標是為胰腺外分泌功能不全的患者提供一種有效的新療法。”CDX-7108計劃進展迅速,發現並開發了這種可口服的酶,用於臨牀開發。“

About Nestlé Health Science and Aimmune Therapeutics

關於雀巢健康科學和免疫療法

Nestlé Health Science is a leader in the science of nutrition and a globally managed business unit of Nestlé. We believe in empowering healthier lives through nutrition and are committed to redefining the management of health, offering an extensive portfolio of science-based active lifestyle nutrition, medical nutrition and pharmaceutical solutions.  Our extensive research network, both within Nestlé's R&D centers as well as with external partners, provides the foundation for products that can help people to live their healthiest lives.  Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries. www.nestlehealthscience.com

雀巢健康科學是營養科學領域的領先者,也是雀巢全球管理的業務部門。我們相信通過營養使生活更健康,並致力於重新定義健康管理,提供以科學為基礎的積極生活方式營養、醫療營養和製藥解決方案的廣泛組合。 我們廣泛的研究網絡,包括雀巢研發中心內部以及與外部合作伙伴,為能夠幫助人們過上最健康生活的產品提供基礎。 總部設在瑞士,我們在世界各地擁有11,000多名員工,產品銷往140多個國家和地區。網址: 

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening gastrointestinal, metabolic, and food-mediated allergic conditions. www.aimmune.com

 是雀巢健康科學公司旗下的AImmune治療公司,是一家生物製藥公司,開發和商業化治療潛在威脅生命的胃腸道、代謝和食物介導的過敏性疾病的藥物。Www.aimmune.com

About Codexis

關於Codexis

Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® platform to discover and develop novel, high performance enzymes and novel biotherapeutics. Codexis enzymes have applications in the sustainable manufacturing of pharmaceuticals, food, and industrial products; in the creation of the next generation of life science tools; and as gene therapy and biologic therapeutics. The Company's unique performance enzymes drive improvements such as: reduced energy usage, waste generation and capital requirements; higher yields; higher fidelity diagnostics; and more efficacious therapeutics. Codexis enzymes enable the promise of synthetic biology to improve the health of people and the planet. For more information, visit www.codexis.com.

Codexis是一家領先的酶工程公司,利用其專有的CodeEvolver®平臺發現和開發新的、高性能的酶和新的生物療法。Codexis酶在藥品、食品和工業產品的可持續製造、下一代生命科學工具的創造以及基因治療和生物治療方面都有應用。該公司獨特的性能酶推動改進,例如:減少能源使用、廢物產生和資本需求;更高的產量;更高的保真度診斷;以及更有效的治療。Codexis酶使合成生物學有望改善人類和地球的健康。欲瞭解更多信息,請訪問www.codexis.com。

Forward-Looking Statements

前瞻性陳述

To the extent that statements contained in this press release are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. To the extent that statements contained in this press release are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitation, statements about the stability and manufacturability of CDX-7108 and the potential use of CDX-7108 for the treatment of exocrine pancreatic insufficiency. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis' control and that could materially affect actual results. Factors that could materially affect actual results include, among others: our and our partners' biotherapeutic programs are early stage, highly regulated and expensive; our and our partners' ability to advance our product candidates to clinical trials and to ultimately receive regulatory approvals is highly uncertain; the regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we and our partners are unable to obtain or maintain regulatory approval for our products and product candidates, our business will be substantially harmed; results of preclinical studies and early clinical trials of product candidates may not be predictive of results of later studies or trials; product candidates may not have favorable results in later clinical trials, if any, or receive regulatory approval; if any product candidates do not work as intended or cause undesirable side effects, it could hinder or prevent receipt of regulatory approval or realization of commercial potential for them or our other product candidates and could substantially harm our business; and even if we obtain regulatory approval for any products that we develop alone or with our partners, such products will remain subject to ongoing regulatory requirements, which may result in significant additional expense.. Additional information about factors that could materially affect actual results can be found in Codexis' Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 1, 2021, and in Codexis' Quarterly Report on Form 10-Q filed with the SEC on August 6, 2021, including under the caption "Risk Factors," and in Codexis' other periodic reports filed with the SEC. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

在某種程度上,本新聞稿中包含的陳述不是對Codexis歷史事實的描述,而是反映了管理層根據1995年“私人證券訴訟改革法”的安全港條款所作的當前信念和期望的前瞻性陳述。在某種程度上,本新聞稿中包含的陳述不是對Codexis歷史事實的描述,而是反映了管理層根據1995年“私人證券訴訟改革法”的安全港條款所作的當前信念和期望的前瞻性陳述。這些聲明包括但不限於關於CDX-7108的穩定性和可製造性的聲明,以及CDX-7108用於治療胰腺外分泌功能不全的潛在用途。您不應過度依賴這些前瞻性陳述,因為它們涉及已知和未知的風險、不確定性和其他因素,在某些情況下,這些風險、不確定性和其他因素超出了Codexis的控制範圍,可能會對實際結果產生重大影響。除其他因素外,可能對實際結果產生重大影響的因素包括:我們和我們合作伙伴的生物治療計劃處於早期階段,受到高度監管和昂貴;我們和我們的合作伙伴將我們的候選產品推進到臨牀試驗並最終獲得監管批准的能力高度不確定;美國食品和藥物管理局(FDA)和類似的外國當局的監管審批過程漫長、耗時,而且本質上不可預測,以及如果我們和我們的合作伙伴無法獲得或維持對我們的產品和候選產品的監管批准, 我們的業務將受到嚴重損害;候選產品的臨牀前研究和早期臨牀試驗結果可能不能預測後續研究或試驗的結果;候選產品可能在以後的臨牀試驗(如果有的話)中沒有有利的結果,或獲得監管部門的批准;如果任何候選產品沒有按預期發揮作用或造成不良副作用,可能會阻礙或阻止獲得監管部門的批准或實現其或我們其他候選產品的商業潛力,並可能對我們的業務造成實質性損害;即使我們單獨開發或與合作伙伴合作開發的任何產品都獲得了監管部門的批准,這些產品仍將受到持續的監管要求的約束,這可能會導致大量的額外費用。有關可能對實際結果產生重大影響的因素的更多信息,請參見美國證券交易委員會於2021年3月1日提交給美國證券交易委員會(“SEC”)的10-K年度報告,以及Codexis於2021年8月6日提交給美國證券交易委員會的Form 10-Q季度報告(包括在“風險因素”標題下),以及Codexis提交給美國證券交易委員會的其他定期報告。除非法律要求,Codexis明確表示沒有任何更新這些前瞻性陳述的意圖或義務。

Investor Relations Contact:
Argot Partners
Stephanie Marks/Carrie McKim
Codexis@argotpartners.com 
(212) 600-1902

投資者關係聯繫人:隱語合夥人斯蒂芬妮·馬克斯/凱莉·麥克金郵箱:codexis@argopartners.com(212) 600-1902


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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