A Single Center, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.

The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects.

开始日期2023-07-06

申办/合作机构

派格生物医药（苏州）股份有限公司

CTR20231655 / Completed临床1期

一项单中心、随机、双盲、安慰剂对照、剂量递增评价 PB-718 注射液在中国肥胖受试者中安全性、耐受性和药代动力学研究

主要目的：评价 PB-718 注射液连续给药在中国肥胖受试者中的安全性和耐受性。次要目的：评价 PB-718 注射液在中国肥胖受试者中的药代动力学（PK）特征；初步评价 PB-718 注射液在中国肥胖受试者中的疗效；评价 PB-718 注射液在中国肥胖受试者中的免疫原性。

开始日期2023-07-06

申办/合作机构

派格生物医药（苏州）股份有限公司

NCT05021666 / Completed临床1期

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB-718 Following Subcutaneous Administration in Healthy Subjects

This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.

开始日期2020-07-29

申办/合作机构

派格生物医药（苏州）股份有限公司

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100 项与 PB-718 相关的临床结果

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100 项与 PB-718 相关的转化医学

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100 项与 PB-718 相关的专利（医药）

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项与 PB-718 相关的文献（医药）

2025-01-01·NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES

Adverse event reporting of combining SGLT2 inhibitor and GLP1 receptor agonist: A real-world study from FAERS

Article

作者: Tian, Chunyan ; Zhang, Ping ; Zhao, Subei ; Yang, Zheng ; Li, Rong

BACKGROUND AND AIMS:

We evaluate whether the combination of sodium-glucose cotransporter-2 inhibitor(SGLT2i) and glucagon-like peptide-1 receptor agonist(GLP1RA) disproportionally increases the reporting of adverse events compared with SGLT2i or GLP1RA monotherapy in the FDA adverse event reporting system (FAERS).

METHODS AND RESULTS:

Adverse events related to SGLT2i and GLP1RA were screened and selected, then data from the FAERS was underwent thorough disproportionality analysis. The proportional reporting ratio(PRR) of SGLT2i-related adverse events were compared between patients using SGLT2i alone and those using both SGLT2i and GLP1RA. Similarly, the PRR of GLP1RA-related adverse events were compared between patients using GLP1RA alone and those using both SGLT2i and GLP1RA. The results showed that the PRR of SGLT2i-related adverse events including diabetic ketoacidosis(DKA), ketosis, reproductive tract adverse events, urinary tract infection, and other adverse events, decreased in individuals using both SGLT2i and GLP1RA compared with those using SGLT2i alone, and the signal of fracture was not detected. Likewise, the PRR of GLP1RA-related adverse events including gastrointestinal adverse events, gallbladder and biliary tract disease, pancreatitis, and other adverse events, decreased in individuals using both SGLT2i and GLP1RA compared with those using GLP1RA alone, the PRR of hyperlipasaemia and hyperamylasaemia increased in the combination therapy and no signal of depression, suicidal and self-injurious behaviour was detected.

CONCLUSION:

Adverse events reporting are not disproportionally higher among those using both SGLT-2i and GLP1RA compared with SGLT2i or GLP1RA monotherapy.

2024-11-01·TOXICOLOGY AND APPLIED PHARMACOLOGY

Toxicology profile of a novel GLP-1 receptor biased agonist-SAL0112 in nonhuman primates

Article

作者: Sun, Jingchao ; Hu, Xuefeng ; Shen, Xiaolei ; Xiao, Ying ; Luo, Binbin ; Zhang, Hongmei ; Ren, Zhiqiang ; Huang, Jing ; Chen, Shu ; Jiang, Rongzhi

Oral small-molecule GLP-1 receptor biased agonists exhibit promising treatment efficacy of type 2 diabetes and obesity. SAL0112 is a novel compound that has demonstrated remarkable efficacy in preclinical animal models. Herein, both in vitro and in vivo preclinical toxicity investigations were conducted to explore the safety profile of SAL0112. The HTRF assay and TR-FRET assay were utilized for cAMP detection. Patch clamp assay was employed for hERG potassium ion channel determination. Cynomolgus monkeys were used in a cardiovascular safety pharmacology study and a 13-week repeated dose toxicity study. The telemetry system was employed to detect cardiovascular indicators such as ECG, HR, and BP. During the repeated dose toxicity study, body weight, food intake, hematology, coagulation function test, serum biochemistry tests, and urine analysis were measured. Macroscopic and microscopic observations were conducted at the end of the study. TK studies were conducted on Day 1 and Day 91. SAL0112 exhibited a high degree of potency in activating the monkey GLP-1 receptor whereas had no effect on the rodent GLP-1 receptor. In contrast to Danuglipron, which demonstrated high potency on hERG with an IC₅₀ value of 6.9 μM, the IC₅₀ of SAL0112 on hERG was greater than 100 μM. Compared to the Vehicle Control group, no significant changes in cardiovascular indicators were observed in the cardiovascular safety pharmacology study after a single dose of SAL0112 up to 250 mg/kg (P > 0.05). A repeated dose toxicity study revealed moderate anorexigenic effects and a reduction in body weight, effects that were found to be reversible and not associated with any pathological changes. The NOAEL of SAL0112 is 150 mg/kg, providing an approximate safety margin of threefold. SAL0112 demonstrated a favorable safety profile in cynomolgus monkeys, with a substantial therapeutic window that supports the progression of this compound into clinical studies.

2024-07-01·JOURNAL OF HEPATOLOGY

Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study

Article

作者: Browne, Sarah K ; Harrison, Stephen A ; Gutierrez, Julio A ; Roberts, M Scot ; Suschak, John J ; Harris, M Scott ; Yang, Jay ; Tomah, Shaheen

BACKGROUND & AIMS:

This was a randomized, double-blind, placebo-controlled study to assess the effects of pemvidutide, a glucagon-like peptide-1 (GLP-1)/glucagon dual receptor agonist, on liver fat content (LFC) in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD).

METHODS:

Patients with a BMI ≥28.0 kg/m² and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks. Participants were stratified according to a diagnosis of type 2 diabetes mellitus. The primary efficacy endpoint was relative reduction (%) from baseline in LFC after 12 weeks of treatment.

RESULTS:

Ninety-four patients were randomized and dosed. Median baseline BMI and LFC across the study population were 36.2 kg/m² and 20.6%; 29% of patients had type 2 diabetes mellitus. At week 12, relative reductions in LFC from baseline were 46.6% (95% CI -63.7 to -29.6), 68.5% (95% CI -84.4 to -52.5), and 57.1% (95% CI -76.1 to -38.1) for the pemvidutide 1.2 mg, 1.8 mg, and 2.4 mg groups, respectively, vs. 4.4% (95% CI -20.2 to 11.3) for the placebo group (p <0.001 vs. placebo, all treatment groups), with 94.4% and 72.2% of patients achieving 30% and 50% reductions in LFC and 55.6% achieving normalization (≤5% LFC) at the 1.8 mg dose. Maximal responses for weight loss (-4.3%; p <0.001), alanine aminotransferase (-13.8 IU/L; p = 0.029), and corrected cT1 (-75.9 ms; p = 0.002) were all observed at the 1.8 mg dose. Pemvidutide was well-tolerated at all doses with no severe or serious adverse events.

CONCLUSIONS:

In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo.

IMPACT AND IMPLICATIONS:

Metabolic dysfunction-associated steatotic liver disease, and its progressive form steatohepatitis, are strongly associated with overweight/obesity and it is believed that the excess liver fat associated with obesity is an important driver of these diseases. Glucagon-like peptide-1 receptor (GLP-1R) agonists elicit weight loss through centrally and peripherally mediated effects on appetite. Unlike GLP-1R agonists, glucagon receptor agonists act directly on the liver to stimulate fatty acid oxidation and inhibit lipogenesis, potentially providing a more potent mechanism for liver fat content reduction than weight loss alone. This study demonstrated the ability of once-weekly treatment with pemvidutide, a dual GLP-1R/glucagon receptor agonist, to significantly reduce liver fat content, hepatic inflammatory activity, and body weight, suggesting that pemvidutide may be an effective treatment for both metabolic dysfunction-associated steatohepatitis and obesity.

CLINICAL TRIAL NUMBER:

NCT05006885.

128

项与 PB-718 相关的新闻（医药）

2024-12-02

·GlobeNewswire-Health Care

Altimmune to Present at the Cachexia Regulatory & Trials Update Workshop of the 17th International Conference of the Society on Sarcopenia, Cachexia & Wasting Disorders

GAITHERSBURG, Md., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that Dr. Scott Harris, Chief Medical Officer at Altimmune, will present body composition data from the Phase 2 MOMENTUM trial of pemvidutide in the treatment of obesity and participate in a panel discussion at the Cachexia Regulatory & Trials Update Workshop of the 17th International Conference of the Society on Sarcopenia, Cachexia & Wasting Disorders in Washington, D.C. Details for the panel discussion are as follows: Title:Muscle Wasting in Weight Loss TherapySession:Treatment Approaches to Address Muscle Wasting in the Context of Obesity Therapy & Regulatory IssuesPresenter:Scott Harris, M.D., Chief Medical Officer, Altimmune, Inc.Date/Time:Friday, December 6, 2024 at 9:30 am ET About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com This press release was published by a CLEAR® Verified individual.

临床2期

2024-11-26

·GlobeNewswire-Health Care

Altimmune to Participate at Two Upcoming Investor Conferences

GAITHERSBURG, Md., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that members of the Company’s management team will participate and be available for 1x1 meetings at the following investor conferences: Annual Evercore HealthCONx Conference (Coral Gables, FL)Tuesday, December 3, 2024Fireside Chat at 10:50 a.m. Eastern Time Piper Sandler Annual Healthcare Conference (New York, NY)Wednesday, December 4, 2024Fireside Chat at 3:30 p.m. Eastern Time The sessions will be webcast and can be accessed by visiting the Events section of the Altimmune website. About AltimmuneAltimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com This press release was published by a CLEAR® Verified individual.

2024-11-15

·GlobeNewswire-Health Care

Altimmune Presents New Data on the Effect of Pemvidutide on Inflammatory Lipids in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) at The Liver Meeting® 2024

Weekly subcutaneous doses of pemvidutide resulted in robust reductions in cardio-inflammatory, hepato-inflammatory and atherosclerotic lipids Findings support the potential benefit of pemvidutide on co-morbidities of metabolic dysfunction-associated steatohepatitis (MASH), including atherosclerosis, heart disease and metabolic syndrome Pemvidutide is currently being evaluated in IMPACT, the Phase 2b trial in subjects with MASH; data readout expected in Q2 2025 GAITHERSBURG, Md., Nov. 15, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented new data from its 12-week Phase 1b trial of pemvidutide in metabolic dysfunction-associated steatotic liver disease (MASLD) at The Liver Meeting® of the American Association for the Study of Liver Diseases. The data showed reductions in multiple classes of inflammatory lipid species associated with adverse cardiovascular outcomes. Pemvidutide is a balanced GLP-1/glucagon dual receptor agonist in development for the treatment of MASH and obesity. The new data were derived from an analysis of plasma samples from subjects who completed a randomized placebo-controlled Phase 1b trial of pemvidutide in subjects with overweight or obesity and MASLD. In the Phase 1b clinical trial, 94 subjects with obesity or overweight and liver fat content (LFC) ≥10% were dosed 1:1:1:1 to pemvidutide (1.2mg, 1.8mg and 2.4mg) or placebo administered once-weekly subcutaneously for 12 weeks. In this study, pemvidutide reduced LFC relative to baseline by up to 68.5% and decreased total cholesterol and triglycerides by up to 12.2% and 44.6%, respectively, after 12 weeks of treatment. The goal of the study was to characterize changes in the lipid profile of patients before and after treatment with pemvidutide. In this study of 50 subjects, treatment with pemvidutide was shown to reduce plasma concentrations of atherogenic lipoproteins and lipotoxic lipid classes associated with MASH and implicated in cardiovascular and atherosclerotic disease. In particular, a rapid and significant reduction in small atherogenic LDL particles was observed in the 1.8 mg and 2.4 mg dose groups compared to placebo. “Cardiovascular events, as opposed to liver-specific events, are the primary co-morbidities associated with MASH, and there is a growing unmet need for a therapy that can not only reduce the inflammation and fibrosis of MASH, but also address key drivers of the longer-term outcomes of the disease,” said Mazen Noureddin, M.D., MHS Director, Cedars-Sinai Medical Center Fatty Liver Program. Dr. Vipin Garg, CEO of Altimmune added, “These data further underscore the potential for pemvidutide to be a differentiated MASH therapy that could address the principal co-morbidities associated with this growing disease. We look forward to sharing results from our ongoing biopsy-driven Phase 2b IMPACT trial of pemvidutide in MASH in the second quarter of 2025.” About Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss with class-leading lean mass preservation, and robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial. About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter Forward-Looking Statement Any statements made in this press release related to the development or commercialization of product candidates and other business matters, including without limitation, trial results and data, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov. Company Contact:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com This press release was published by a CLEAR® Verified individual.

临床2期临床结果快速通道临床1期

100 项与 PB-718 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肥胖	临床2期	中国	派格生物医药（苏州）股份有限公司	2023-07-06
非酒精性脂肪性肝炎	临床1期	全球	派格生物医药（苏州）股份有限公司	2022-07-20

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06147544 (ADA2024) 人工标引	临床1/2期	肥胖	36	PB-718	範鹹築範簾餘積製鏇廠(鏇網範襯鑰襯鹹鏇築鏇) = GI side effects were the most common AEs, and were all grade 1 in severity. 鹹窪鹹鹹鏇醖網醖齋憲 (壓淵糧遞觸簾積鑰憲襯 ) 更多	积极	2024-06-21
				Placebo