Galecto Publishes Results Showing Safety and Efficacy of the GB0139 Inhaled Galectin-3 Inhibitor in Hospitalized COVID-19 Patients on Standard of Care
Galecto Publishes Results Showing Safety and Efficacy of the GB0139 Inhaled Galectin-3 Inhibitor in Hospitalized COVID-19 Patients on Standard of Care
Results Support Favorable Safety and Tolerability Profile and Target Engagement of GB0139 and Potential for GB0139 in Severe Lung Disease
Company Provides Update on GALACTIC-1 Trial
BOSTON, Jan. 27, 2022 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the publication of the full results of an investigator-initiated open and randomized trial to evaluate Galecto's inhaled galectin-3 inhibitor, GB0139, in hospitalized patients with COVID-19 infection who required oxygen but not mechanical ventilation, compared to patients only on standard of care.
Galectin-3 plays a key role in COVID-19-related acute lung injury, cytokine storm, T-cell exhaustion and organ micro-thrombosis, and the results from this trial suggest that GB0139 has the potential for treatment of viral induced acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).
The study met its primary endpoint of safety as there were no observed treatment-related adverse events. Despite patients having a mean age of 65 years, mean BMI of 32, multiple comorbidities, and being breathless, all patients were able to effectively inhale GB0139 and achieve pharmacologically relevant plasma levels. Target engagement was confirmed with a statistically significant reduction (p<0.01) in serum galectin-3 levels.
The study showed that GB0139 on top of standard of care (which included treatments such as steroids, heparin, remdesivir and tocilizumab) may rapidly decrease markers of inflammation linked to the cytokine storm, inflammation-associated micro-thrombosis and those of short or long-term fibrosis. Patients treated with GB0139 had a significantly greater rate of decline in oxygen requirement versus standard of care alone and showed other signs of reduced organ damage. These effects were further accentuated in a subgroup of patients with moderate-to-severe disease who were at higher clinical risk. These patients showed multiple signs of improved immune-mediated viral responses as well as decreased lymphocyte exhaustion and decreased level of profibrotic macrophages. A 21% reduction of mortality was observed in this subgroup of patients at high clinical risk.
Professor Bertil Lindmark, Chief Medical Officer of Galecto, stated, "We are excited that the results of this study showed that GB0139 was biologically active and safely administered at high doses (20mg and 10mg) to patients with severe lung disease and difficulties breathing. Galectin-3 inhibition prevents key escalation steps of the viral-induced inflammatory response, including inflammation related thrombosis, and the processes of acute and chronic fibrosis. These novel findings enhance our conviction for the potentially wide medical applicability of our expanding portfolio of galectin-3 inhibitors."
Dr. Hans Schambye, President and Chief Executive Officer of Galecto, commented, "The published results further demonstrate the positive impact of galectin-3 inhibition in patients with severe lung disease. The safety and tolerability profile of GB0139 in patients with compromised lung function is encouraging, and we believe suggests additional potential in virus-induced acute lung injury. Given these exciting data, we plan to explore co-development opportunities with GB0139 for the treatment of COVID-19 and other severe viral lung diseases. Furthermore, the data from this study aligns with our findings in our IPF clinical trials completed to date and reaffirms the potential efficacy of GB0139 in our ongoing GALACTIC-1 trial."
The GALACTIC-1 trial is a Phase 2b, 52-week randomized, double-blind, multicenter, parallel, placebo-controlled trial investigating the safety and efficacy of GB0139 (3mg) in patients with IPF, with the rate of decline of forced vital capacity (FVC) as the primary endpoint. Based on blinded FVC (lung function) data from patients in this trial, the Company has determined that it may be possible to demonstrate a meaningful effect with fewer than the planned target of up to 210 randomized patients. As a result of this statistical analysis, the Company plans to seek regulatory approval of a protocol amendment to reduce the target patient population for the GALACTIC-1 trial, which would enable Galecto to maintain the cost structure of the trial and report topline results in mid-2023, as previously reported.
The research article is titled "GB0139, an inhaled small molecule inhibitor of galectin-3, in COVID-19 pneumonitis: A randomised, controlled, open-label, Phase 2a experimental medicine trial of the safety, pharmacokinetics, and potential therapeutic value." It is available through the medRxiv preprint server and has not yet been peer-reviewed. Galecto has submitted the article to a peer-reviewed publication and has had an abstract of the trial results accepted for presentation at the 2022 American Thoracic Society (ATS) Conference in San Francisco, CA from May 13-18, 2022.
COVID-19 Trial
In this open-label trial ( 41 patients were randomized to receive either standard of care, which included treatments such as steroids, heparin, remdesivir and tocilizumab (n=21), or inhaled GB0139 (dosed at 10 mg twice a day for 2 days and subsequently once a day for up to 14 days) plus standard of care (n=20), to evaluate the safety and tolerability of GB0139, pharmacokinetics, and its effects on clinical outcomes and biomarkers. Patients had a mean age of 65 years, mean BMI of 32, multiple comorbidities, and were hospitalized and needed oxygen therapy, but did not require mechanical ventilation.
About Galecto
Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 (and the galectin family generally) and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a phase 2 trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a phase 1b/2a trial in liver cirrhosis and a separate phase 2 trial for the treatment of NSCLC in combination with atezolizumab (Tecentriq®).
Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit .
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the tolerability and efficacy of GB0139 in COVID-19 lung inflammation; that GB0139 may reduce lung fibrosis seen in COVID-19 patients; that GB0139 has the potential to counter the cytokine storm, inflammation-associated thrombosis, short and long-term fibrosis and multi-organ damage; the GALACTIC-1 trial, including plans for continuing to enroll patients and working with regulatory authorities to amend the protocol for the trial; that Galecto intends to submit the research article to a peer reviewed publication; as well as Galecto's general focus, plans for clinical development, product candidates and pipeline. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto's product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto's filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto's Annual Report on Form 10-K, as filed with the SEC on March 29, 2021. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
For more information, contact:
Galecto, Inc. | |
Hans Schambye, CEO | |
Jon Freve, CFO | |
+45 70 70 52 10 | |
Investors/US | Media/EU |
Ashley R. Robinson | Sandya von der Weid |
arr@lifesciadvisors.com | svonderweid@lifesciadvisors.com |
+1 617 430 7577 | +41 78 680 0538 |
結果支持GB0139良好的安全性和耐受性,並支持GB0139在重症肺部疾病中的潛在靶向性。
該公司提供銀河一號試驗的最新情況
波士頓,2022年1月27日(環球網)--專注於開發治療纖維化和癌症的新療法的臨牀階段生物技術公司加萊克託公司(納斯達克市場代碼:GLTO)今天宣佈,一項由研究者發起的公開隨機試驗的全部結果已經公佈,該試驗旨在評估加萊克託公司的吸入型半乳糖凝集素-3抑制劑GB0139在住院的新冠肺炎感染患者(需要氧氣但不需要機械通氣)和只接受標準護理的患者中的療效。
半乳糖凝集素-3在新冠肺炎相關的急性肺損傷、細胞因子風暴、T細胞耗竭和器官微血栓形成中起關鍵作用,本實驗結果提示半乳糖凝集素-3具有治療病毒性急性呼吸窘迫綜合徵和急性肺損傷(阿里巴巴-SW)的潛力。
這項研究達到了安全性的主要終點,因為沒有觀察到與治療相關的不良事件。儘管患者的平均年齡為65歲,平均BMI為32,合併多種疾病,呼吸困難,但所有患者都能夠有效地吸入GB0139,並達到與藥物相關的血漿水平。確認了目標參與度,並在統計上顯著降低(p
研究表明,GB0139在標準治療(包括類固醇、肝素、瑞德維韋和tocilizumab等治療)的基礎上,可能會迅速降低與細胞因子風暴有關的炎症標誌物、炎症相關的微血栓形成以及短期或長期纖維化的標誌物。接受GB0139治療的患者比單獨接受治療的患者的需氧量下降的速度要大得多,並顯示出器官損傷減少的其他跡象。這些影響在臨牀風險較高的中到重度疾病患者亞組中進一步突出。這些患者表現出免疫介導的病毒反應改善的多種跡象,以及淋巴細胞耗竭減少和促纖維化巨噬細胞水平降低。在這組臨牀風險較高的患者中,觀察到死亡率降低了21%。
Galecto公司首席醫療官Bertil Lindmark教授説:“我們很高興看到這項研究的結果表明GB0139具有生物活性,在大劑量(20毫克和10毫克)下安全地給患有嚴重肺部疾病和呼吸困難的患者使用。抑制Galectin-3可以阻止病毒引起的炎症反應的關鍵步驟,包括炎症相關的血栓形成,以及急性和慢性纖維化的過程。這些新的發現增強了我們對我們不斷擴大的Galectin-3抑制劑產品組合潛在的廣泛醫學適用性的信心。”
Galecto公司總裁兼首席執行官漢斯·沙姆拜博士評論説:“公佈的結果進一步證明瞭Galectin-3抑制劑對嚴重肺部疾病患者的積極影響。GB0139在肺功能受損患者中的安全性和耐受性是令人鼓舞的,我們認為這表明病毒誘導的急性肺損傷具有額外的潛力。鑑於這些令人興奮的數據,我們計劃探索與GB0139共同開發治療新冠肺炎和其他嚴重病毒性肺部疾病的機會。此外,這項研究的數據與我們迄今已完成的IPF臨牀試驗結果一致,並重申了GB0139在我們正在進行的銀河1號試驗中的潛在功效。“
銀河1號試驗是一項2b期、為期52周的隨機、雙盲、多中心、平行、安慰劑對照試驗,以用力肺活量(FVC)下降率為主要終點,調查GB0139(3毫克)對特發性肺纖維化患者的安全性和有效性。根據這項試驗中患者的FVC(肺功能)盲法數據,該公司已經確定,有可能在少於多達210名隨機患者的計劃目標的情況下證明有意義的效果。作為這一統計分析的結果,該公司計劃尋求監管部門批准一項方案修正案,以減少Galaxy-1試驗的目標患者人數,這將使Galecto能夠維持試驗的成本結構,並如之前報道的那樣,在2023年年中報告背線結果。
這篇研究文章的標題是“半乳糖凝集素-3的吸入性小分子抑制劑GB0139治療新冠肺炎肺炎:一項隨機、對照、開放標籤、2a期的安全性實驗藥物試驗藥代動力學和潛在的治療價值“它可以通過medRxiv預印本服務器獲得,還沒有經過同行審查。Galecto已經向同行審查的出版物提交了這篇文章,並已經收到了一份試驗結果摘要,供2022年5月13日至18日在加利福尼亞州舊金山舉行的2022年美國胸科學會(ATS)會議上提交。
新冠肺炎試用版
在這項開放標籤試驗(41名患者)中,41名患者被隨機分為兩組,一組接受標準治療(包括類固醇、肝素、雷米昔韋和tocilizumab等治療,n=21),另一組接受吸入GB0139(每天兩次,每次10毫克,連續服用2天,隨後每天一次,最多14天)加標準治療(n=20),以評估GB0139的安全性和耐受性、藥代動力學及其對臨牀結果和生物標誌物的影響。患者的平均年齡為65歲,平均體重指數為32,合併多種疾病,住院並需要氧療,但不需要機械通氣。
關於Galecto
Galecto是一家在美國註冊成立的臨牀階段公司,正在開發Galectin-3(以及Galectin家族)和LOXL2的小分子抑制劑。Galecto公司有多個正在進行的纖維化和癌症第二階段臨牀計劃,包括(I)治療特發性肺纖維化(IPF)的2b期試驗中的吸入型Galectin-3調節劑(GB0139);(Ii)治療骨髓纖維化的第二階段試驗中的口服活性LOXL2抑制劑(GB2064);(Iii)1b/2期中的口服活性Galectin-3抑制劑(GB1211);肝硬化試驗和單獨的第二階段試驗。®).
Galecto打算利用其網站作為披露重大非公開信息的手段。有關Galecto的定期更新,請訪問。
前瞻性陳述
本新聞稿中的某些陳述是前瞻性陳述,涉及許多風險和不確定性。此類前瞻性陳述包括以下陳述:GB0139對新冠肺炎肺部炎症的耐受性和有效性;GB0139可減少新冠肺炎患者的肺纖維化;GB0139具有對抗細胞因子風暴、炎症相關血栓形成、短期和長期纖維化以及多器官損害的潛力;銀河1號試驗,包括繼續招募患者和與監管機構合作修改試驗方案的計劃;Galecto打算將該研究文章提交給同行評議的出版物;以及Galecto的一般説明。“可能”、“將”、“可能”、“將”、“應該”、“預期”、“計劃”、“預期”、“打算”、“相信”、“估計”、“預測”、“項目”、“潛在”、“繼續”、“目標”以及類似的表述旨在識別前瞻性表述,儘管並不是所有的前瞻性表述都包含這些標識性詞語。對於這樣的聲明,Galecto聲稱受到1995年私人證券訴訟改革法案的保護。實際事件或結果可能與Galecto的預期大不相同。可能導致實際結果與前瞻性陳述大不相同的因素包括與Galecto公司候選產品的開發及其治療潛力有關的風險和不確定因素,是否有足夠的資金及其使用,以及Galecto公司提交給美國證券交易委員會(美國證券交易委員會)的文件中披露的那些風險和不確定性,這些文件包括但不限於Galecto公司於3月29日提交給美國證券交易委員會的10-K表格年度報告。, 2021年這些前瞻性陳述代表Galecto在本新聞稿發佈時的判斷。除適用法律可能要求的情況外,Galecto公司不承擔任何更新這些前瞻性陳述的意圖或義務。
如需更多信息,請聯繫:
Galecto,Inc. | |
漢斯·夏姆拜,首席執行官 | |
喬恩·弗裏夫(Jon Freve),首席財務官 | |
+45 70 70 52 10 | |
投資者/美國 | 媒體/歐盟 |
阿什利·R·羅賓遜 | 桑迪亞·馮·德韋德 |
郵箱:arr@lifescivisors.com | 郵箱:svonderweid@lifescivisors.com |
+1 617 430 7577 | +41 78 680 0538 |
譯文內容由第三人軟體翻譯。
風險及免責聲明
- 分享到weixin
- 分享到qq
- 分享到facebook
- 分享到twitter
- 分享到微博
- 粘贴板
使用瀏覽器的分享功能,分享給你的好友吧