Silo Pharma Initiates Pharmacokinetic and Tolerability Study for SP-26 Targeting Chronic Pain and Fibromyalgia
Silo Pharma Initiates Pharmacokinetic and Tolerability Study for SP-26 Targeting Chronic Pain and Fibromyalgia
"So far this year we have conducted several studies of our SP-26 ketamine implants including analytical testing and small batch proof-of-concept extrusion trials, manufacturing and production evaluation, and sterilization and dissolution tests, with what we believe are encouraging results," said Silo CEO Eric Weisblum. "The advancement of this program into animal studies is an important milestone achievement as we work to bring a safe and effective and to our knowledge, first-of-its-kind ketamine treatment for those living with chronic pain."Key preclinical milestone for novel, non-opioid extended-release pain therapeutic
關鍵的前臨床里程碑，針對新型非阿片類的緩釋疼痛治療
SARASOTA, FL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) ("Silo" or the "Company"), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced the initiation of a pharmacokinetic (PK) and tolerability study in partnership with its contract research organization (CRO), AmplifyBio. The study is designed to assess the pharmacokinetics of Silo's dissolvable ketamine-based injectable implant, SP-26, in a minipig model. SP-26 is being developed as a self-administered, non-opioid therapeutic aimed at treating chronic pain and fibromyalgia.
SARASOTA, FL, 2024年12月18日 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (納斯達克: SILO) ("Silo"或"公司"), 一家專注於開發傳統療法和迷幻治療的新型製劑和藥物遞送系統的發展階段生物製藥公司，今天宣佈與其合同研究機構(CRO) AmplifyBio合作啓動藥代動力學(PK)和耐受性研究。該研究旨在評估Silo的可溶性氯胺酮注射植入物SP-26在迷你豬模型中的藥代動力學。SP-26正在開發爲一種自我給藥的非阿片類治療，用於治療慢性疼痛和纖維肌痛。
The non-GLP study, set to span three weeks, will investigate the absorption, distribution, metabolism, and excretion (ADME) of extended-release ketamine hydrochloride implants. Two distinct polymer formulations will be tested at varying dose levels.
該非GLP研究計劃爲期三週，將研究緩釋氯胺酮植入物的吸收、分佈、代謝和排泄(ADME)。將測試兩種不同的聚合物配方，採用不同的劑量水平。
"So far this year we have conducted several studies of our SP-26 ketamine implants including analytical testing and small batch proof-of-concept extrusion trials, manufacturing and production evaluation, and sterilization and dissolution tests, with what we believe are encouraging results," said Silo CEO Eric Weisblum. "The advancement of this program into animal studies is an important milestone achievement as we work to bring a safe and effective and to our knowledge, first-of-its-kind ketamine treatment for those living with chronic pain."
「到目前爲止，今年我們已經對SP-26氯胺酮植入物進行了幾項研究，包括分析測試和小批次概念驗證擠出試驗、製造與生產評估、以及滅菌和溶解測試，我們相信這些結果令人鼓舞，」 Silo首席執行官Eric Weisblum表示。「該項目進入動物研究是一個重要的里程碑，因爲我們努力爲慢性疼痛患者提供安全有效的、到我們所知的第一種氯胺酮治療。」
"AmplifyBio is honored to support Silo Pharma in this critical safety milestone for SP-26. We understand and take seriously the trust put in us to execute the PK study efficiently and with excellence," said Jerry Hacker, EVP, and Chief Commercial Officer for AmplifyBio.
"AmplifyBio很榮幸能支持Silo Pharma在SP-26這一關鍵安全里程碑上。我們理解並非常重視寄予我們的信任，以高效和卓越的方式執行Pk研究，"AmplifyBio的執行副總裁兼首席商業官Jerry Hacker表示。
About SP-26
關於SP-26
SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval.
SP-26是一種基於氯胺酮的可注射可溶性聚合物植入物，用於治療慢性疼痛和纖維肌痛。該皮下植入物旨在安全調節疼痛緩解治療的劑量和釋放時間。如果臨床成功，SP-26可能符合FDA簡化的505(b)(2)藥物批准監管途徑。
About Silo Pharma
關於Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company's lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo's two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer's disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo's research and development programs are conducted through collaborations with universities and independent laboratories. For more information, visit and connect on social media at LinkedIn , X , and Facebook .
Silo Pharma Inc.（納斯達克：SILO）是一家開發階段的生物製藥公司，致力於開發新的治療方法，以應對被忽視的病症，包括壓力引發的精神疾病、慢性疼痛和中樞神經系統（CNS）疾病。Silo專注於開發傳統療法和新型配方及藥物遞送系統的迷幻治療。該公司的主導項目SPC-15是一種針對創傷後應激障礙（PTSD）和壓力引發的焦慮障礙的鼻用治療。SP-26是一種用於纖維肌痛和慢性疼痛緩解的時效釋放氯胺酮植入物。Silo的兩個臨床前項目爲SPC-14，一種用於治療阿爾茨海默病的鼻用Compound，以及SPU-16，一種靶向多發性硬化症（MS）的CNS趨向肽。Silo的研究和開發項目通過與高校和獨立實驗室的合作開展。更多信息，請訪問並在社交媒體上通過LinkedIn、X和Facebook連接。
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words "could", "believe", "anticipate", "intend", "estimate", "expect", "may", "continue", "predict", "potential", and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. ("Silo" or "the Company") to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company's technology platforms, retaining and expanding the Company's customer base, fluctuations in consumer spending on the Company's products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this news release, whether as a result of new information, future events, or otherwise, after the date of this news release or to reflect the occurrence of unanticipated events except as required by law.
前瞻性聲明
本新聞稿包含了1995年《私人證券訴訟改革法案》「安全港」條款下的「前瞻性陳述」。這些陳述通過使用「可能」、「相信」、「預期」、「打算」、「估計」、「期待」、「可能」、「繼續」、「預測」、「潛在」和類似表達來進行識別，這些詞旨在識別前瞻性陳述。這些陳述涉及已知和未知的風險、不確定性以及其他可能導致Silo Pharma, Inc.（「Silo」或「公司」）的實際結果與此類陳述所表達或暗示的結果有實質性差異的因素，包括對預計收入來源的變化、未來的經濟和競爭條件、開發公司技術平台的困難、保留和擴展公司客戶基礎的挑戰、消費者對公司產品的支出波動以及其他因素。因此，儘管公司相信此類前瞻性陳述中反映的期望是合理的，但不能保證這些期望會正確得到驗證。公司不承擔任何公開更新或發佈本新聞稿中所包含的前瞻性信息修訂的義務，無論是由於新信息、未來事件，還是其他原因，除非法律要求的情況下。
Contact
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investors@silopharma.com
聯繫
800-705-0120
investors@silopharma.com
譯文內容由第三人軟體翻譯。