A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects

The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.

Start Date27 May 2024

Sponsor / Collaborator

PegBio Co., Ltd.

CTR20241107 / Active, not recruitingPhase 1

一项单中心、随机、双盲、安慰剂对照、剂量递增研究评价聚乙二醇化艾塞那肽注射液（PB-119）在中国肥胖受试者中的安全性、耐受性和药代动力学特征

[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetic characteristics of pegylated exenatide injection (PB-119) in Chinese obese subjects

评价PB-119连续给药在中国肥胖受试者中的安全性和耐受性。评价PB-119在中国肥胖受试者中的药代动力学（PK）特征；评价PB-119在中国肥胖受试者中的疗效；评价PB-119在中国肥胖受试者中的免疫原性；评价PB-119在中国肥胖受试者中的药效动力学（PD）特征；评价PB-119对中国肥胖受试者的QT间期的影响。

[Translation]

To evaluate the safety and tolerability of continuous administration of PB-119 in obese Chinese subjects. To evaluate the pharmacokinetic (PK) characteristics of PB-119 in obese Chinese subjects. To evaluate the efficacy of PB-119 in obese Chinese subjects. To evaluate the immunogenicity of PB-119 in obese Chinese subjects. To evaluate the pharmacodynamic (PD) characteristics of PB-119 in obese Chinese subjects. To evaluate the effect of PB-119 on the QT interval of obese Chinese subjects.

Start Date23 May 2024

Sponsor / Collaborator

PegBio Co., Ltd.

NCT06147544 / CompletedPhase 1/2

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.

Start Date06 Jul 2023

Sponsor / Collaborator

PegBio Co., Ltd.

100 Clinical Results associated with PegBio Co., Ltd.

0 Patents (Medical) associated with PegBio Co., Ltd.

Literatures (Medical) associated with PegBio Co., Ltd.

01 Jun 2024·The Lancet Regional Health - Western Pacific

Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial

Article

Author: Ma, Jianhua ; Liu, Li ; Xu, Michael ; Jia, Ying ; Wang, Xuhong ; Li, Sheli ; Zhou, Zhiguang ; Yan, Xiang ; Zhu, Yikun ; Ding, Ke ; Liu, Jie ; Lin, Jingna ; Mo, Zhaohui ; Yan, Shuang ; Liu, Yan

BackgroundType 2 diabetes (T2DM) remains a challenge to treat despite the expansion of various therapeutic classes. Visepegenatide (PB-119) is a once a week, subcutaneous, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection without the requirement of dose titration that has shown glycaemic control and safety profile in two phase 2 studies conducted in China and the United States, respectively. The aim of this study was to evaluate the efficacy and safety of visepegenatide as a monotherapy in treatment-naïve patients with T2DM.MethodsThis was a multicentre, double-blind, parallel, placebo-controlled, phase 3 trial conducted in 30 centres in China. Adult participants (aged 18-75 years) with T2DM, glycated haemoglobin (HbA1c) of 7.5%-11.0% [58.47-96.73 mmol/mol], body mass index (BMI) of 18-40 kg/m², and who had been treated with diet and exercise alone for at least 8 weeks before the screening visit were eligible for enrolment. After a 4-week placebo injection run-in period, participants with HbA1c of 7.0%-10.5% [53.0-91.3 mmol/mol] and fasting plasma glucose (FPG) < 15 mmol/L were randomised in a ratio of 1:1 to receive visepegenatide (150 μg) or placebo subcutaneous injections once a week for 24 weeks. The treatment was extended to another 28 weeks during which all participants received visepegenatide. The primary outcome was a change in HbA1c from baseline to week 24. This study was registered with ClinicalTrials.gov, as NCT04504370.FindingsBetween November 2, 2020, and November 2, 2022, we randomly assigned 273 adult participants to the visepegenatide (n = 137) and placebo (n = 136) groups. In total, 257 (94.12%) participants, 131 (95.6%) on visepegenatide, and 126 (92.6%) on placebo, completed the double-blinded treatment period. At baseline, the mean (SD) HbA1c was 8.47% (0.81) [69.07 [8.81] mmol/mol], which rapidly decreased to 7.63% (0.80) [59.94 [8.70] mmol/mol] with visepegenatide by week 4 of treatment, and the change from baseline was significantly greater than that in the placebo group (-0.82% [-0.90 to -0.74]; [-8.99 [-9.89 to -8.10] mmol/mol] vs -0.30% [-0.41 to -0.19]; [-3.30 [-4.50 to -2.09] mmol/mol]). At week 24, when evaluating the effects of treatment with treatment policy estimand, the least square mean (LSM change in HbA1c from baseline was -1.36 (95% confidence interval [CI] -1.52 to -1.20) [-14.84 [-16.60 to -13.08] mmol/mol] in the visepegenatide group vs -0.63 (-0.79 to -0.46) [-6.84 [-8.61 to -5.07] mmol/mol] in the placebo group. The reduction in HbA1c was significantly greater with visepegenatide than placebo (LSM difference -0.73, 95% CI -0.96 to -0.50; p < 0.001). When evaluating the treatment estimand with hypothetic policy, the LSM change in HbA1c from baseline in the visepegenatide group (-1.37 [-1.53 to -1.20]) [-14.95 [-16.76 to -13.14] mmol/mol] was significantly greater than the placebo group (-0.63 [-0.81 to -0.45]) [6.90 (-8.89 to -4.90) mmol/mol]. The LSM difference was (-0.74, 95% CI -0.98 to -0.49; [-8.00 [-10.50 to -5.50] mmol/mol]; p < 0.001]. A significantly greater proportion of the visepegenatide group achieved a target HbA1c level of <7% (<53 mmol/mol) than the placebo (50.4% vs 14.2%; p < 0.05) and stringent HbA1c level of ≤6.5% (≤48 mmol/mol) (26.7% vs 7.9%), respectively. There was also a significantly greater improvement in FPG, 2-h postprandial glucose, homeostasis model assessment (HOMA) of beta cell function, post-prandial insulin, fasting, and post-prandial C-peptide level (p < 0.05) with visepegenatide treatment. The number (3 [2.2%]) of participants who received rescue therapy in the visepegenatide group was remarkably lower compared with those (17 [12.5%]) in the placebo group (p < 0.05). During the extended treatment period, visepegenatide consistently maintained the efficacy till week 52 confirmed by all the above endpoints. The reduction in HbA1c at week 52 was -1.39% (-1.58 to -1.19) [-15.14 [-17.28 to -13.01] mmol/mol], which was even greater than that at week 24. There was also a significant improvement in HOMA-insulin resistance (p = 0.004) at week 52 compared with the baseline value. For the placebo→visepegenatide group, which received visepegenatide in the extended treatment period, a notable decrease in HbA1c at week 52 compared to baseline was observed. The change from baseline in HbA1c was -1.49% (-1.68 to -1.30) [-16.27 [-18.37 to -14.16] mmol/mol]. The outcome was in the same direction as the visepegenatide group from the double-blind treatment period. Comprehensive benefits of visepegenatide including weight loss, improvement in lipid profile, and reduction in blood pressure have been demonstrated in this study. Visepegenatide reduced the body weight in a BMI-dependent manner that was prominent in BMI ˃32 kg/m² with a mean (SD) reduction of -4.77 (13.94) kg at week 52 (p < 0.05). Incidences of gastrointestinal adverse events were less common than other weekly GLP-1 RA in the market, and most of the adverse events were mild and moderate in nature, occurring in the first weeks of the treatment, and were transient. No serious hypoglycaemia or grade 2 hypoglycaemia (blood glucose: ≤3 mmol/L) was reported during the study.InterpretationAs a monotherapy, visepegenatide provided rapid without the risk of hypoglycaemia, significant, and sustainable glycaemic control by improving islet β-cell function and insulin resistance. Treatment with visepegenatide induced early treatment response in reducing HbA1c and maintaining glycaemic control for 52 weeks. Meanwhile, visepegenatide provided a comprehensive benefit in body weight loss, lipids, and blood pressure reduction. Visepegenatide had a better safety profile than other weekly GLP-1 RA in participants with T2DM even without the requirement of dose titration. Visepegenatide would provide an optimal treatment approach with its high benefit and low-risk balance.FundingPegBio Co., Ltd.

01 Jan 2024·Clinical Pharmacokinetics

Population Pharmacokinetic/Pharmacodynamic Analysis of the Glucokinase Activator PB201 in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus: Facilitating the Clinical Development of PB201 in China

Article

Author: Lin, Zhigang ; Liang, Ruifang ; Cao, Fangrui ; Ding, Ke ; Niu, Shu ; Song, Ling ; Xu, Michael ; Liu, Dongyang ; Yao, Xueting

PB201 is an orally active, partial glucokinase activator targeting both pancreatic and hepatic glucokinase. As the second glucokinase activator studied beyond phase I, PB201 has demonstrated promising glycemic effects as well as favorable pharmacokinetic (PK) and safety profiles in patients with type 2 diabetes mellitus (T2DM). This study aims to develop a population PK/pharmacodynamic (PD) model for PB201 using the pooled data from nine phase I/II clinical trials conducted in non-Chinese healthy volunteers and a T2DM population and to predict the PK/PD profile of PB201 in a Chinese T2DM population. We developed the PK/PD model using the non-linear mixed-effects modeling approach. All runs were performed using the first-order conditional estimation method with interaction. The pharmacokinetics of PB201 were well fitted by a one-compartment model with saturable absorption and linear elimination. The PD effects of PB201 on reducing the fasting plasma glucose and glycosylated hemoglobin levels in the T2DM population were described by indirect response models as stimulating the elimination of fasting plasma glucose, where the production of glycosylated hemoglobin was assumed to be stimulated by fasting plasma glucose. Covariate analyses revealed enhanced absorption of PB201 by food and decreased systemic clearance with ketoconazole co-administration, while no significant covariate was identified for the pharmacodynamics. The population PK model established for non-Chinese populations was shown to be applicable to the Chinese T2DM population as verified by the PK data from the Chinese phase I study. The final population PK/PD model predicted persistent and dose-dependent reductions in fasting plasma glucose and glycosylated hemoglobin levels in the Chinese T2DM population receiving 50/50 mg, 100/50 mg, and 100/100 mg PB201 twice daily for 24 weeks independent of co-administration of metformin. Overall, the proposed population PK/PD model quantitatively characterized the PK/PD properties of PB201 and the impact of covariates on its target populations, which allows the leveraging of extensive data in non-Chinese populations with the limited data in the Chinese T2DM population to successfully supported the waiver of the clinical phase II trial and facilitate the optimal dose regimen design of a pivotal phase III study of PB201 in China.

01 Dec 2021·eClinicalMedicine

Safety, tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator PB-201 and its effects on the glucose excursion profile in drug-naïve Chinese patients with type 2 diabetes: a randomised controlled, crossover, single-centre phase 1 trial

Article

Author: Ji, Linong ; Yao, Xueting ; Li, Haiyan ; Zhou, Hong ; Liu, Dongyang ; Wei, Yudong ; Cui, Cheng ; Xu, Min ; Zhu, Jixiang ; Du, Ying

BACKGROUNDPB-201, a partial, pancreas/liver-dual glucokinase activator, showed good tolerance and glycaemic effects in multinational studies. This study determined its optimal dose, safety, pharmacokinetics, and pharmacodynamics in Chinese patients with type 2 diabetes.METHODSIn this double-blind, randomised, four-period, crossover, phase 1 trial in China, conducted at the Peking University Third Hospital, adult patients with drug-naive type 2 diabetes were randomised (1:1:1:1) to four sequence groups using a computer-generated randomisation table. In each period, they received oral placebo or PB-201 (50+50, 100+50, or 100+100 mg split doses) for 7 days. Investigators and patients were masked to treatment assignment. The primary endpoints were safety and pharmacokinetics. Continuous glucose monitoring was used to delineate the glucose excursion profile. Trial registration number: NCT03973515.FINDINGSBetween August 27, 2019 and December 19, 2019, 16 patients were randomised. PB-201 showed a dose-proportional pharmacokinetic profile without apparent accumulation in the body and induced dose-dependent lowering of blood glucose. PB-201 at 50+50, 100+50, and 100+100 mg increased mean time in range (49·210% [standard deviation 27], 56·130% [25], and 63·330% [20] with three doses, respectively) versus placebo (49·380% [27]) and reduced estimated glycated haemoglobin from baseline (-0·5445% [1·654], -1·063% [1·236], and -1·888% [1·381] vs -0·581% [1·200]). Fifteen patients (93·8%) had treatment-emergent adverse events, which were mild. No patients had hypoglycaemia with venous/capillary glucose <3·9 mmol/L or nocturnal hypoglycaemia.INTERPRETATIONPB-201 100 mg twice daily is identified as the optimal dose, which shows promising glucose-lowering effects and low risks of hypoglycaemia and other side effects. Further investigation of PB-201 100 mg twice daily in confirmatory trials is warranted.FUNDINGPegBio.

News (Medical) associated with PegBio Co., Ltd.

27 Oct 2022

·www.prnewswire.com

China's PegBio Selects LifeSphere by ArisGlobal for Safety Case Processing

LifeSphere Safety increases its customer footprint, further solidifying its safety market leadership position. MIAMI, Oct. 27, 2022 /PRNewswire/ -- ArisGlobal, the leading provider of life sciences software designed to automate core drug development functions with its end-to-end technology platform LifeSphere®, has expanded the global adoption of LifeSphere Safety by adding PegBio Co., Ltd. to its customer roster. PegBio selected LifeSphere MultiVigilance, a flagship product within the market-leading safety product line, to transition its pharmacovigilance from Contract Research Organization (CRO) services to in-house practices with the leading pharmacovigilance software. Continue Reading ArisGlobal Logo (PRNewsfoto/ArisGlobal) "At PegBio, we are laser-focused on fighting chronic disease with safe, novel, and effective therapies, and we hold patient safety in the highest regard," shares Ruifang Liang, Senior VP of PegBio. "We believe that by moving our pharmacovigilance strategy to ArisGlobal's LifeSphere, we will be able to not only meet, but exceed, safety expectations and efficiencies." LifeSphere Safety will enable PegBio, a biopharma specialized in the development of diabetes and obesity therapies, to bring operations in-house and control drug development through customized service, authority connection, cloud service, and bilingual language translation capabilities. "LifeSphere Safety is several years ahead of any other safety solution on the market, and we are thrilled to welcome PegBio to our customer roster as an innovative organization working towards chronic disease therapies," says Ye Zha, Head of Country, China, at ArisGlobal. "With the increased prioritization of safety, in-house pharmacovigilance has become essential. LifeSphere MultiVigilance will provide a critical level of support and enhance PegBio's ability to safely and efficiently develop and deliver drugs in this key global market and beyond." By adding PegBio to its portfolio, ArisGlobal continues growing its commitment to pharmacovigilance and the safety of global drug development along with its ever-expanding footprint within China's life sciences sector. For more information about ArisGlobal and the LifeSphere Safety platform, please visit arisglobal.com. About PegBio Founded in 2008, Pegbio Co., Ltd. is a biomedical enterprise committed to the research and development and production of innovative drugs in the field of chronic disease treatment, which has developed a series of advantageous products, including polypeptide drugs, protein drugs, and small molecule drugs through independent research and development. About LifeSphere LifeSphere® is the trusted partner for global pharmaceutical and biotechnology companies, health authorities, and contract research organizations. Helping accelerate product development, organize clinical trials, manage compliance, and streamline collaboration across teams, LifeSphere empowers safer, faster life science breakthroughs. As the flagship platform of ArisGlobal, LifeSphere is a market-leading solution built on 40 years of industry partnership and continues to evolve in collaboration with hundreds of trusted customers worldwide. For more information visit lifesphere.arisglobal.com. About ArisGlobal ArisGlobal is led by passionate individuals who support life sciences leaders in developing and monitoring breakthrough medicines and therapies. With more than 35 years of expertise in the life sciences industry, ArisGlobal develops technology products within the platform LifeSphere to power pharmaceutical and biotech research and development. Building on our commitment to corporate social responsibility and sustainability initiatives, we give back to the communities where we live and work – in the U.S, Europe, India, Japan, and China. For more information visit . SOURCE ArisGlobal

Innovative DrugSmall molecular drug

18 Jan 2021

·medcitynews.com

Memorial Sloan Kettering computational pathology spinoff raises $100M

Paige, A computational pathology startup spun out of Memorial Sloan Kettering, raised $100 million in a series C funding round. The New York-based company is developing clinical decision support tools for pathologists, and plans to use the funds to further advance its technology. Paige was started in 2018 by Dr. Thomas Fuchs, who spun out the company from research at Memorial Sloan Kettering Cancer Center. The startup had a research agreement to receive de-identified images of digitized pathology slides, which it is using to make AI tools across multiple cancer subtypes, and the Memorial Sloan Kettering holds an equity stake in the company. Earlier this year, Paige received 510(k) clearance from the Food and Drug Administration for a digital pathology image viewer. It also received a Breakthrough Device designation from the FDA for an AI tool for cancer diagnosis. None of Paige’s clinical decision support tools are yet cleared to be used for diagnostics in the U.S. But in Europe, it has two CE-marked solutions to detect areas of suspected prostate cancer or breast cancer. With the new funds, Paige plans to double its headcount, with roughly 70 new employees across its engineering and commercial teams. “This investment reaffirms the vast potential of the Paige platform for clinical and biopharmaceutical drug development applications,” Paige CEO Leo Grady said in a news release. “These funds will enable us to build additional AI-based products within and outside of oncology, deliver these products to laboratories and clinicians globally, and invest in our talent across engineering and commercial functions.” Photo credit: Abscent84, Getty Images

15 Jan 2021

·www.nsmedicaldevices.com

Paige secures $100m funding to support digital pathology transformation

Paige will use the funding to advance the transformation of digital pathology by leveraging insights from patient’s sample Paige to transform digital pathology. (Credit: Chokniti Khongchum from Pixabay.) Paige has secured $100m in a Series C funding round, led by Casdin Capital and Johnson & Johnson Innovation (JJDC), the strategic venture capital arm of Johnson & Johnson. The company intends to use the funding to advance the transformation of digital pathology by leveraging insights from patient’s sample, to help pathologists, care teams and researchers make effective decisions. The AI-based digital diagnostics firm said that existing investors and other funds also participated in the Series C funding round. Casdin Capital chief investment officer Eli Casdin said: “Bending the mortality curve on cancer is a humbling and critical goal requiring big data, big technology and big talent. “Paige combines all three: Robust AI capabilities, access to millions of digital pathology images linked to the key clinical data modalities of imaging, genomic, and clinical/EMR data, and a growing team purpose built to deliver. “This is a unique opportunity to transform data into a next generation of cancer diagnostics and therapeutics, with clear application beyond cancer, and we are excited to be joined by JJDC to fuel the company to deliver on this opportunity.” Paige to expand its engineering team in 2021 Apart from advancing the development of AI-based clinical applications, biomarkers and diagnostics, Paige is also planning to invest in sales and marketing efforts for rapid scaling of product adoption by hospitals and labs. The company is expected to further expand its engineering and commercial teams by hiring around 70 new employees in 2021, which would double its size. Established in 2017, Paige is engaged in creating computational pathology products designed to help patients and care teams for effective treatment decisions. By leveraging advanced AI-based technologies, the company has created a platform to transform pathologists’ workflow and enhance diagnostic productivity. Paige claimed that it is the first company to receive US Food and Drug Administration (FDA) breakthrough designation for computational pathology products. Paige chief executive officer Leo Grady said: “Paige is building a transformational portfolio of computational pathology products to serve clinical needs and drive precision medicine. “This investment reaffirms the vast potential of the Paige platform for clinical and biopharmaceutical drug development applications. “These funds will enable us to build additional AI-based products within and outside of oncology, deliver these products to laboratories and clinicians globally, and invest in our talent across engineering and commercial functions.” In July 2020, Paige has received the FDA 510(k) approval for its digital pathology image viewer FullFocus, for primary diagnosis.

100 Deals associated with PegBio Co., Ltd.

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Pipeline Snapshot as of 18 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Visepegenatide ( GLP-1R )	Diabetes Mellitus, Type 2 More	NDA/BLA
Nerigliatin ( glucokinase )	Diabetes Mellitus, Type 2 More	Phase 3
PB-718 ( GCGR x GLP-1R )	Obesity More	Phase 2 Clinical
PB-1802 ( Uric acid )	Gout More	Phase 2
PB-1902 ( μ opioid receptor )	Opioid-Induced Constipation More	Phase 1

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