A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of PJ009 in Patients with Short Bowel Syndrome Requiring Parenteral Nutrition

The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition. The main questions it aims to answer are:
* How effective is PJ009 in treating short bowel syndrome?
* Is PJ009 safe in these patients? Researchers will compare PJ009 to a placebo (a look-alike substance that contains no drug) to see if PJ009 works to treat SBS.
Participants will
* Receive daily subcutaneous injections of PJ009 or placebo according to weight for 24 weeks, and then the participants receive placebo will be switched to receive PJ009 for another 12 weeks, while participants receive PJ009 continued the same treatment until the end of 36 weeks,
* Visit the clinic at the end of week 1(w1), w2, w4, w8, w12, w16, w20, w24, w30 and w36 for assessment,
* Keep a diary of the amount of their parenteral nutrition/ intravenous fluids (PN/IV), enteral nutrition and urine volume.

Start Date03 Sep 2024

Sponsor / Collaborator

Chongqing Paijin Biotechnology Co Ltd.

CTR20241372 / RecruitingPhase 3

评价PJ009在需肠外营养支持的短肠综合征患者中的有效性和安全性的多中心、随机、双盲、安慰剂对照的III期研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of PJ009 in patients with short bowel syndrome requiring parenteral nutrition support

评价需肠外营养支持的短肠综合征(SBS)患者使用PJ009的有效性

[Translation]

To evaluate the effectiveness of PJ009 in patients with short bowel syndrome (SBS) requiring parenteral nutrition support

Start Date05 Jul 2024

Sponsor / Collaborator

Chongqing Paijin Biotechnology Co Ltd.

CTR20230106 / CompletedPhase 1

评价PJ009 单次和多次给药在健康志愿者体内的安全耐受性、药代动力学（PK）的单中心、随机、双盲、安慰剂对照的剂量爬坡I 期临床研究

[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics (PK) of PJ009 in healthy volunteers after single and multiple administrations

主要目的：评价PJ009在健康受试者体内的安全性和耐受性。次要目的： 1)考察PJ009在健康志愿者中单、多次给药的药代动力学（PK）特征。 2)考察PJ009在健康志愿者中的免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of PJ009 in healthy subjects. Secondary objectives: 1) To investigate the pharmacokinetic (PK) characteristics of PJ009 after single and multiple administrations in healthy volunteers. 2) To investigate the immunogenicity of PJ009 in healthy volunteers.

Start Date28 Feb 2023

Sponsor / Collaborator

Chongqing Paijin Biotechnology Co Ltd.

100 Clinical Results associated with Teduglutide Recombinant(Chongqing Paijin Biotechnology)

100 Translational Medicine associated with Teduglutide Recombinant(Chongqing Paijin Biotechnology)

100 Patents (Medical) associated with Teduglutide Recombinant(Chongqing Paijin Biotechnology)

Literatures (Medical) associated with Teduglutide Recombinant(Chongqing Paijin Biotechnology)

01 Nov 2024·Small

Orally Delivered Stimulus‐Sensitive Nanomedicine to Harness Teduglutide Efficacy in Inflammatory Bowel Disease

Article

Author: Harris, Alan ; Pinho, Salomé ; Sarmento, Bruno ; Martins, Claúdia ; Viegas, Juliana ; Nunes, Rute ; Pinto, Soraia ; Alves, Inês ; Barros, Andreia S. ; Almeida, Helena

AbstractInflammatory Bowel Disease (IBD) is a chronic inflammatory condition affecting the gastrointestinal tract (GIT). Glucagon‐like peptide‐2 (GLP‐2) analogs possess high potential in the treatment of IBD by enhancing intestinal repair and attenuating inflammation. Due to the enzymatic degradation and poor intestinal absorption, GLP‐2 analogs are administered parenterally, which leads to poor patient compliance. This work aims to develop IBD‐targeted nanoparticles (NPs) for the oral delivery of the GLP‐2 analog, Teduglutide (TED). Leveraging the overproduction of Reactive Oxygen Species (ROS) in the IBD environment, ROS‐sensitive NPs are developed to target the intestinal epithelium, bypassing the mucus barrier. PEGylation of NPs facilitates mucus transposition, but subsequent PEG removal is crucial for cellular internalization. This de‐PEGylation is possible by including a ROS‐sensitive thioketal linker within the system. ROS‐sensitive NPs are established, with the ability to fully de‐PEGylate via ROS‐mediated cleavage. Encapsulation of TED into NPs resulted in the absence of absorption in 3D in vitro models, potentially promoting a localized action, and avoiding adverse effects due to systemic absorption. Upon oral administration to colitis‐induced mice, ROS‐sensitive NPs are located in the colon, displaying healing capacity and reducing inflammation. Cleavable PEGylated NPs demonstrate effective potential in managing IBD symptoms and modulating the disease's progression.

01 Oct 2024·Endocrine Practice

Impact of Teprotumumab on Clinical Practice in Thyroid Eye Disease

Article

Author: Wagner, Lilly H ; Rachmasari, Kharisa N ; Stan, Marius N ; Tooley, Andrea A ; Toro-Tobon, David ; Bradley, Elizabeth A

BACKGROUNDFollowing its Food and Drug Administration approval in January 2020, we examined the impact of teprotumumab on thyroid eye disease (TED) clinical practices.METHODSAcross 3 referral centers from January 1, 2018, to December 30, 2022, we retrospectively analyzed demographics, clinical features, treatment choices, and insurance status of patients with active, moderate to severe TED.RESULTSOf 74 patients recommended for medical therapy, 53% received collaborative recommendations from endocrinologists and ophthalmologists in a TED clinic. Prior to teprotumumab availability, 19 patients were recommended medical therapy, and all received medical therapy (100%), which consists of corticosteroids (14, 73.7%) or tocilizumab (5, 26.3%). After teprotumumab became available, out of 55 patients that were recommended medical therapy, only 41 (74.6%) received medical therapy, mostly teprotumumab (33, 60%), followed by corticosteroids (5, 9.1%) or tocilizumab (3, 5.4%), while 14 (25.4%) did not receive medical therapy. Discordance between physicians' recommendations and therapy received or lack thereof was explained by patients' refusal (9, 64.3%), mostly due to side effect concerns (8, 88.9%), and insurance denial (5, 35.7%). Teprotumumab use was mostly associated with otic changes (10, 30.3%), weight loss (9, 27.3%), and hyperglycemia (6, 18.2%), but 2 (6.1%) patients developed serious infections. Corticosteroids were associated with insomnia (4, 21.1%), and 1 patient in the tocilizumab group had an infusion reaction requiring hospitalization.CONCLUSIONTeprotumumab introduction increased TED therapy evaluations, yet not all received recommended treatment due to safety concerns or accessibility issues. Enhancing collaborative care, medication accessibility, and adverse effect management is crucial.

01 Jul 2024·Thyroid®

Long-Term Efficacy of Teprotumumab in Thyroid Eye Disease: Follow-Up Outcomes in Three Clinical Trials

Article

Author: Conrad, Elizabeth ; Holt, Robert J ; Subramanian, Prem S ; Kahaly, George J ; Smith, Terry J

Introduction: Thyroid eye disease (TED) is an autoimmune process characterized by extraocular muscle and orbital fat remodeling/expansion resulting in swelling, pain, redness, proptosis, and diplopia. Teprotumumab, an insulin-like growth factor-I receptor inhibitor, demonstrated improvements in TED signs and symptoms in three adequately powered clinical trials of 24 weeks duration. Here we analyze the long-term maintenance of responses with teprotumumab from these trials. Methods: A total of 112 patients who received 7 or 8 infusions of teprotumumab in the Phase 2, Phase 3 (OPTIC study), and OPTIC Extension (OPTIC-X) studies were included in this analysis. Responses, including clinical activity score (CAS ≥2-point improvement), the European Group of Graves' Orbitopathy ophthalmic composite outcome, diplopia (≥1 Gorman grade improvement), proptosis (≥2 mm improvement), Overall (improvement in proptosis + CAS), and disease inactivation (CAS ≤1), were assessed and pooled from study baseline to week 24 (formal study) and up to week 72 (formal follow-up). Graves' Ophthalmopathy quality-of-life (GO-QoL) scores were also assessed. Outcomes included the percentages of observed patient responses from the study baseline. Additional alternative treatments for TED were assessed as a surrogate of persistent benefit from week 24 through week 120 (extended follow-up). Studies differed in the timing of follow-up visits, and data from some visits were unavailable. Results: At week 72, 52/57 (91.2%), 51/57 (89.5%), 35/48 (72.9%), 38/56 (67.9%), and 37/56 (66.1%) of patients were responders for CAS, composite outcome, diplopia, proptosis, and Overall response, respectively. The mean reduction in proptosis was 2.68 mm (SD 1.92, n = 56), mean GO-QoL improvement was 15.22 (SE 2.82, n = 56), and disease inactivation (CAS ≤1) was detected in 40/57 (70.2%). Over 99 weeks following teprotumumab therapy, 19/106 (17.9%) patients reported additional TED therapy during formal and extended follow-up. Conclusion: The long-term response to teprotumumab as observed 51 weeks after therapy was similar to week 24 results in the controlled clinical trials. Inflammatory and ophthalmic composite outcome improvements were seen in 90% of patients with nearly 70% reporting improvement in diplopia and proptosis. Further, 82% of patients in this analysis did not report additional TED treatment (including surgery) over 99 weeks following the final teprotumumab dose.

100 Deals associated with Teduglutide Recombinant(Chongqing Paijin Biotechnology)

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Indication	Highest Phase	Country/Location	Organization	Date
Short Bowel Syndrome	Phase 3	CN	Chongqing Paijin Biotechnology Co Ltd.	05 Jul 2024

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