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Tharimmune Announces Positive Results in Phase 1 Clinical Trial of TH104, Its Lead Clinical Therapeutic Candidate

Tharimmune Announces Positive Results in Phase 1 Clinical Trial of TH104, Its Lead Clinical Therapeutic Candidate

Tharimmune 宣佈其主要臨床候選療法 TH104 的 1 期臨床試驗取得積極結果
Accesswire ·  02/20 21:01

Positive safety/tolerability profile achieved with TH104 showing self-resolving, mild side effect profile aligned with previous studies

TH104 具有良好的安全性/耐受性,表現出可自我消退、輕微的副作用特徵,與先前的研究一致

Phase 1 clinical trial compared oral transmucosal delivery of TH104 to injectable reference approved drug completed

已完成的 1 期臨床試驗比較了口服經粘膜給藥 TH104 與可注射的參考藥物

Company fully funded into 2025 with Phase 2 moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) study on-track and expected to initiate in 2024

公司在 2025 年獲得全額資助,原發性膽源性膽管炎 (PBC) 第 2 期中度至重度慢性瘙癢研究已步入正軌,預計將於 2024 年啓動

BRIDGEWATER, NJ / ACCESSWIRE / February 20, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology announced today the completion of the Company's Phase 1 clinical trial with TH104. TH104 is a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene which easily adheres inside of the mouth on the cheek and biodegrades within minutes. TH104, is designed to avoid the liver's first pass metabolism seen in oral formulations and may be an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the mu and kappa opioid receptors. These well-known mu and kappa receptors, when stimulated and/or inhibited by the body's endogenous ligands, have been implicated in the body's itch circuitry for certain conditions, specifically cholestatic or dysregulated bile acid-related liver conditions.

新澤西州布里奇沃特/ACCESSWIRE/2024年2月20日/Tharimmune, Inc.(納斯達克股票代碼:THAR)(“Tharimmune” 或 “公司”)是一家處於臨床階段的生物技術公司,正在開發炎症和免疫學候選治療產品組合,今天宣佈完成該公司針對 TH104 的1期臨床試驗。TH104 是一種專有的透粘膜口腔膜,內嵌經批准的活性化合物納美芬,可輕鬆粘附在口腔內的臉頰上,並在幾分鐘內生物降解。TH104 旨在避免口服制劑中出現的肝臟首次代謝,可能是多種肝臟相關炎症和其他瘙癢性炎症的理想候選產品。該分子具有影響 mu 和 kappa 阿片類藥物受體的雙重作用機制。這些衆所周知的 mu 和 kappa 受體在受人體內源性配體的刺激和/或抑制時,會與人體的瘙癢迴路有關,尤其是與膽汁淤積或膽汁酸失調相關的肝臟疾病。

The completed Phase 1 clinical trial was a pharmacokinetic bridging study in the U.S. and was designed as a single-dose, single-center, open-label, randomized 2-way crossover study with 16 mg of TH104 compared to an intravenous 1 mg dose of nalmefene administered under fasting conditions, with a 7-day washout period between doses. Sixteen subjects were planned and pre-specified to complete both doses of the crossover design per the study protocol. Twenty normal healthy volunteers participated, and 19 subjects completed the study. The primary objective was to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability. The Phase 1 pharmacokinetic analysis is ongoing and topline readout and full data are expected to be achieved in the second quarter of 2024.

已完成的 1 期臨床試驗是美國的一項藥代動力學橋接研究,設計爲一項單劑量、單中心、開放標籤、隨機雙向交叉研究,採用 16 mg TH104,而在空腹條件下靜脈注射 1 mg 劑量的納美芬,兩次劑量之間的沖洗期爲 7 天。根據研究方案,計劃並預先指定了16名受試者完成兩劑交叉設計。20名正常的健康志願者參與了這項研究,19名受試者完成了研究。主要目標是評估 TH104 的絕對生物利用度以及評估安全性和耐受性。第一階段的藥代動力學分析正在進行中,預計將在2024年第二季度實現頂線讀數和完整數據。

The Phase 1 study demonstrated that TH104 had a comparable safety and tolerability profile to the FDA approved nalmefene reference intravenous formulation of the drug. In the preliminary analysis of the completed trial safety results, all adverse events reported in the clinical trial were categorized as mild and were evenly reported between TH104 and intravenous injection. One patient did not return for the second dose of the study after a 7-day washout post the first dose which was unrelated to the study. There were no deaths, serious adverse events, or other significant adverse events reported during the entire study with events consistent with the safety profile of marketed formulations as well as those described in the literature including self-resolving nausea, dizziness, and drowsiness per previous reports with nalmefene.

第一階段研究表明,TH104 的安全性和耐受性與美國食品藥品管理局批准的納美芬參考靜脈注射配方相當。在對已完成的試驗安全性結果的初步分析中,臨床試驗中報告的所有不良事件均歸類爲輕度,在 TH104 和靜脈注射之間均勻報告。一名患者在第一劑量服用7天后沒有回來接受第二劑研究,這與研究無關。在整個研究過程中,沒有報告死亡、嚴重不良事件或其他重大不良事件,這些事件與上市制劑的安全性以及文獻中描述的事件一致,包括納美芬先前的報告中描述的自我解決的噁心、頭暈和嗜睡。

"We are pleased with the completion of our Phase 1 study of TH104 and our expectations for a safe and tolerable transmucosal film delivery have been met," said Randy Milby, Chief Executive Officer of Tharimmune. "We would like to thank the Trial subjects for participating in this program where the data generated are a critical step forward to continue our momentum and remain on-track to initiate a Phase 2 program this year."

Tharimmune首席執行官蘭迪·米爾比表示:“我們對TH104 的1期研究的完成感到高興,我們對安全和可耐受的透粘膜膜交付的期望也得到了滿足。”“我們要感謝試驗受試者參與該計劃,生成的數據是向前邁出的關鍵一步,可以保持我們的勢頭,並保持今年啓動第二階段計劃的正軌。”

Primary biliary cholangitis (PBC) is a chronic cholestatic autoimmune disease with debilitating symptoms, including pruritus or "unrelenting itching" and fatigue. Pruritus is a common clinical feature seen in liver diseases but particularly frequent in cholestatic liver disease. A recent study found that pruritus in PBC is under-treated in clinical practice in the United States. Current treatment options may only be partially effective or poorly tolerated and are not FDA-approved for cholestatic pruritus in patients with PBC, therefore effective solutions for this significant problem are a high unmet need.

原發性膽汁性膽管炎(PBC)是一種慢性膽汁淤積性自身免疫性疾病,具有使人衰弱的症狀,包括瘙癢或 “持續瘙癢” 和疲勞。瘙癢是肝臟疾病中常見的臨床特徵,但在膽汁淤積性肝病中尤其常見。最近的一項研究發現,在美國,PBC的瘙癢症在臨床實踐中治療不足。目前的治療方案可能僅部分有效或耐受性差,未獲美國食品藥品管理局批准用於PBC患者的膽汁淤積性瘙癢,因此,這一重大問題的有效解決方案是大量未得到滿足的需求。

Earlier, we announced data from several ex-US human studies with TH104 showing consistent and predictable delivery of nalmefene in healthy subjects using our proprietary drug embedded transmucosal buccal film. Another previously disclosed study of an open-label trial using TH104 in cholestatic liver disease patients showed a 33.3% decline in 24-hour itch intensity when administered a single low-dose. Safety and tolerability in these studies were consistent with published studies in the literature with nalmefene, the active ingredient in TH104 and are aligned with the profile from the most recent study announced today.

早些時候,我們公佈了幾項前美國人體研究 TH104 的數據,這些數據顯示,使用我們的專有藥物嵌入式透粘膜口腔膜,納美芬在健康受試者中持續且可預測的輸送。另一項先前披露的對膽汁淤積性肝病患者使用 TH104 的開放標籤試驗的研究顯示,單次低劑量給藥後,24 小時瘙癢強度會降低 33.3%。這些研究的安全性和耐受性與文獻中發表的有關 TH104 活性成分納美芬的研究一致,也與今天宣佈的最新研究的概況一致。

Tharimmune announced last quarter the closing of an $11 million public offering which it believes is sufficient to extend its cash runway into early 2025 for clinical readouts of its lead program, TH104. The Company plans to advance both its clinical and non-clinical programs and announce an R&D Day in 2Q24 to update stakeholders and patients.

Tharimmune上季度宣佈完成1,100萬美元的公開募股,該公司認爲這足以將其現金流延長至2025年初,用於臨床公佈其主要項目 TH104。該公司計劃推進其臨床和非臨床項目,並宣佈在24年第二季度設立研發日,以向利益相關者和患者通報最新情況。

About TH104
TH104 is embedded with nalmefene onto a proprietary transdermal buccal film which easily adheres to the inside of the mouth. This endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the μ-opioid and kappa opioid receptors. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the body's itch circuitry.

關於 TH104
TH104 將 nalmefene 嵌入到專有的透皮口腔薄膜上,可輕鬆粘附在口腔內部。這賦予了 TH104 的關鍵特性,使其成爲多種肝臟相關炎症和其他瘙癢性炎症的理想候選產品。該分子具有影響μ-阿片類藥物和Kappa阿片類藥物受體的雙重作用機制。衆所周知,這些阿片類藥物受體在受到人體天然配體的刺激和/或抑制時會參與人體的瘙癢迴路。

About Pruritus and Primary Biliary Cholangitis
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC, is a chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile which causes liver damage. The disease, believed to be an autoimmune condition, affects an estimated 58 out of every 100,000 U.S. women and about 15 out of every 100,000 U.S. men. Pruritus is one of the most common symptoms associated with PBC affecting up to 75% of individuals at some point during their disease course. It has a negative impact on health-related quality of life with limited treatment options.Published survey data of PBC respondents suffering from pruritus described their itch as "bugs crawling under the skin". More than 65% of patients reported that the itch was worse at night, known as nocturnal pruritus, a high unmet need.

關於瘙癢症和原發性膽源性膽管炎
根據美國國立衛生研究院下屬的國家糖尿病和消化與腎臟疾病研究所(NIDDK)的說法,PBC是一種慢性疾病,肝臟中的膽管最終功能失調,導致膽汁積聚,從而導致肝損傷。這種疾病被認爲是一種自身免疫性疾病,估計每10萬名美國女性中有58人受到影響,每10萬名美國男性中約有15人受到影響。瘙癢是與PBC相關的最常見症狀之一,多達75%的人在病程的某個時候會受到影響。它對與健康相關的生活質量產生負面影響,治療選擇有限。已公佈的PBC受訪者患有瘙癢症的調查數據將他們的瘙癢描述爲 “蟲子在皮膚下爬行”。超過65%的患者報告說,夜間瘙癢加重,稱爲夜間瘙癢,這種需求很高,未得到滿足。

About Tharimmune
Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104 is known to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets. For more information please visit: .

關於 Tharimmune
Tharimmune, Inc. 是一家處於臨床階段的生物技術公司,正在開發炎症和免疫學候選治療產品組合。衆所周知,作爲該公司臨床階段的主要資產,TH104 可以抑制PBC的慢性、使人衰弱的瘙癢或 “無法控制的瘙癢”,這是一種罕見的孤兒性肝病,尚無治癒方法。該公司的早期免疫學產品線包括靶向獨特表位的新型多特異性抗體,這些抗體具有針對包括PD-1、HER2和HER3在內的多種實體瘤中已知的、經過驗證的靶標的新型作用機制。Tharimmune與Omniab, Inc.簽訂了許可協議,可以訪問該公司針對這些靶標和其他特定靶標的抗體發現技術平台。欲了解更多信息,請訪問: 。

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K/A for the year ended December 31, 2022 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

前瞻性陳述
根據1995年《私人證券訴訟改革法》,本新聞稿中的某些陳述是前瞻性的。除歷史事實陳述外,本新聞稿中包含的所有陳述,包括有關Tharimmune的戰略、未來運營、未來財務狀況、預計成本、前景、計劃和管理目標的聲明,均爲前瞻性陳述。“預期”、“相信”、“繼續”、“可能”、“取決於”、“估計”、“預期”、“打算”、“可能”、“持續”、“計劃”、“潛力”、“預測”、“項目”、“目標”、“應該”、“將” 和類似的表達方式旨在識別前瞻性陳述,儘管並非所有前瞻性陳述都包含這些識別性詞語。公司實際上可能無法實現這些前瞻性陳述中披露的計劃、意圖或預期,您不應過分依賴這些前瞻性陳述。實際業績或事件可能與這些前瞻性陳述中披露的計劃、意圖和預期存在重大差異。可能導致此類差異的因素包括但不限於我們在截至2022年12月31日止年度的10-K/A表年度報告以及公司不時向美國證券交易委員會提交的其他定期報告中列出的風險因素中討論的因素。此外,本新聞稿中包含的前瞻性陳述代表公司截至本新聞稿發佈之日的觀點。後續的事件和事態發展可能導致公司的觀點發生變化;但是,除非適用法律要求,否則公司不承諾也明確表示沒有義務更新或修改任何前瞻性陳述以反映新信息、未來事件或情況或反映意外事件的發生。截至本新聞稿發佈之日後的任何日期,不應將這些前瞻性陳述視爲代表公司的觀點。

Investor Relations Contact
ir@tharimmune.com

投資者關係聯繫人
ir@tharimmune.com

SOURCE: Tharimmune, Inc.

來源:Tharimmune, Inc.


譯文內容由第三人軟體翻譯。


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