A Phase 1, Multi-center, Parallel, Open-label, Pharmacokinetic, Safety, and Tolerability Study of Venglustat Given as a Single Dose in Adult Participants With Mild, Moderate, and Severe Hepatic Impairment and in Matched Participants With Normal Hepatic Function

This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat.
The purpose of this study is to assess the effect of mild, moderate, and severe hepatic impairment on PK, safety, and tolerability of venglustat compared with normal hepatic function in male and female participants aged 18 to 79 years.
Study details include:
The total study duration per participant will be up to 42 days, including up to 21 days for screening and approximately 21 days from institutionalization to the end of study (EOS).
Institutionalization is mandatory until the activities on D5 have been completed.
Each participant will receive a single dose of venglustat.
For hepatically impaired participants there will be a screening visit, a multi-day institutionalization visit, and 7 site visits after D5 discharge, including the end of study (EOS) visit.
For healthy volunteers there will be a screening visit, a multi-day institutionalization visit and 3 site visits after D5 discharge, including the end of study (EOS) visit.

Start Date18 Jan 2023

Sponsor / Collaborator

Sanofi

CTR20221236 / Active, not recruitingPhase 3

一项III期、国际多中心、随机、双盲、双模拟、阳性对照研究，评价venglustat在酶替代疗法（ERT）治疗后达到治疗目标的3型戈谢病（GD3）成人和青少年患者中的疗效和安全性

[Translation] A Phase III, international, multicenter, randomized, double-blind, double-dummy, active-controlled study evaluating the efficacy and safety of venglustat in adults and adolescents with Gaucher disease type 3 (GD3) who have reached treatment goals after enzyme replacement therapy (ERT)

主要目的：通过评估以下指标，评价venglustat与思而赞相比在成人和青少年（≥12至<18岁）GD3患者中的疗效： - 共济失调（根据共济失调评估与评分量表[SARA]评估） - 认知功能（根据可重复成套神经心理状态测验[RBANS]确定）次要目的：1）评估与思而赞相比venglustat对维持脾脏体积稳定的作用 2）评估与思而赞相比venglustat对维持肝脏体积稳定的作用 3）评估与思而赞相比venglustat对维持血红蛋白水平稳定的作用 4）评估与思而赞相比venglustat对维持血小板计数稳定的作用 5）评估与思而赞相比venglustat的安全性和耐受性 6）评价与思而赞相比 venglustat 对脑脊液 (CSF) GL-1 和 lyso-GL-1 生物标志物变化的作用 7）评价与思而赞相比 venglustat 对血浆 GL-1 和 lyso-GL-1 生物标志物变化的作用

[Translation]

Primary Objective: To evaluate the efficacy of venglustat compared to cerebral ischemia in adults and adolescents (≥12 to <18 years old) with GD3 by evaluating the following indicators: - Ataxia (assessed by the Scale for the Assessment and Rating of Ataxia [SARA]) - Cognitive function (determined by the Repeatable Battery of Neuropsychological Status [RBANS]) Secondary Objectives: 1) To evaluate the effect of venglustat on maintaining stable spleen volume compared to cerebral ischemia 2) To evaluate the effect of venglustat on maintaining stable liver volume compared to cerebral ischemia 3) To evaluate the effect of venglustat on maintaining stable hemoglobin levels compared to cerebral ischemia 4) To evaluate the effect of venglustat on maintaining stable platelet counts compared to cerebral ischemia 5) To evaluate the safety and tolerability of venglustat compared to cerebral ischemia 6) To evaluate the effect of venglustat on changes in cerebrospinal fluid (CSF) GL-1 and lyso-GL-1 biomarkers compared to cerebral ischemia 7) To evaluate the effect of venglustat on changes in plasma GL-1 and Role of changes in lyso-GL-1 biomarkers

Start Date19 Aug 2022

Sponsor / Collaborator

Sanofi Winthrop Industrie SA

[+4]

CTR20220800 / RecruitingPhase 3

一项随机、开放标签、平行组、为期18个月的III期研究，在法布雷病伴左心室肥大受试者中评价与常用标准治疗相比，venglustat对左心室质量指数的影响

[Translation] A randomized, open-label, parallel-group, 18-month phase III study evaluating the effect of venglustat on left ventricular mass index compared with standard therapy in subjects with Fabry disease and left ventricular hypertrophy

主要目的：与法布雷病标准治疗相比，venglustat治疗18个月对法布雷病伴左心室肥大受试者左心室质量指数的影响。次要目的：评价venglustat对肾功能的影响；评价与标准治疗相比，venglustat对心脏功能和心脏脂质贮存的影响；评价 venglustat 对下肢肿胀和疲倦的影响；评估venglustat在法布雷病受试者中的安全性和耐受性；评价venglustat在法布雷病受试者中的PK

[Translation]

Primary objective: Effect of 18 months of treatment with venglustat on left ventricular mass index in subjects with Fabry disease and left ventricular hypertrophy compared with standard of care. Secondary objectives: To evaluate the effect of venglustat on renal function; To evaluate the effect of venglustat on cardiac function and cardiac lipid storage compared with standard of care; To evaluate the effect of venglustat on lower extremity swelling and fatigue; To assess the safety and tolerability of venglustat in subjects with Fabry disease; To evaluate the PK of venglustat in subjects with Fabry disease

Start Date13 Jul 2022

Sponsor / Collaborator

Sanofi Winthrop Industrie SA

[+2]

100 Clinical Results associated with Ibiglustat

100 Translational Medicine associated with Ibiglustat

100 Patents (Medical) associated with Ibiglustat

Literatures (Medical) associated with Ibiglustat

01 Sep 2024·Neurobiology of Disease

Decreasing ganglioside synthesis delays motor and cognitive symptom onset in Spg11 knockout mice

Article

Author: Ricca, Ivana ; Samaroo, Dominic ; Menuet, Alexia ; Colombo, Sophie ; Cowling, Belinda ; Devaux, Morgan ; Colsch, Benoit ; Santorelli, Filippo M ; Branchu, Julien ; Becker, Julien ; El Hachimi, Khalid-Hamid ; Mero, Serena ; Durr, Alexandra ; Dorgham, Karim ; Stevanin, Giovanni ; Fortier, Manon ; Dobrenis, Kostantin ; Cauhapé, Margaux ; Buono, Suzie ; Darios, Frédéric

Biallelic variants in the SPG11 gene account for the most common form of autosomal recessive hereditary spastic paraplegia characterized by motor and cognitive impairment, with currently no therapeutic option. We previously observed in a Spg11 knockout mouse that neurodegeneration is associated with accumulation of gangliosides in lysosomes. To test whether a substrate reduction therapy could be a therapeutic option, we downregulated the key enzyme involved in ganglioside biosynthesis using an AAV-PHP.eB viral vector expressing a miRNA targeting St3gal5. Downregulation of St3gal5 in Spg11 knockout mice prevented the accumulation of gangliosides, delayed the onset of motor and cognitive symptoms, and prevented the upregulation of serum levels of neurofilament light chain, a biomarker widely used in neurodegenerative diseases. Importantly, similar results were observed when Spg11 knockout mice were administrated venglustat, a pharmacological inhibitor of glucosylceramide synthase expected to decrease ganglioside synthesis. Downregulation of St3gal5 or venglustat administration in Spg11 knockout mice strongly decreased the formation of axonal spheroids, previously associated with impaired trafficking. Venglustat had similar effect on cultured human SPG11 neurons. In conclusion, this work identifies the first disease-modifying therapeutic strategy in SPG11, and provides data supporting its relevance for therapeutic testing in SPG11 patients.

01 Sep 2024·Acta Cardiologica Sinica

2024 Update of the TSOC Expert Consensus of Fabry Disease.

Article

Author: Chang, Hao-Chih ; Tseng, Hsinyu ; Wang, Tzung-Dau ; Yu, Wen-Chung ; Wu, Yen-Wen ; Chen, Po-Sheng ; Juang, Jyh-Ming Jimmy ; Lin, Heng-Hsu ; Lai, Chih-Hung ; Kao, Yung-Ta ; Huang, Chun-Yao ; Chu, Chun-Yuan ; Wang, Chun-Li ; Chang, Wei-Ting ; Chang, Chia-Hsiu ; Wang, Wen-Hwa ; Sung, Kuo-Tzu ; Kuo, Ling ; Hung, Chung-Lieh ; Chen, Wen-Jone ; Wang, Chao-Yung ; Lin, Chih-Chan

As an X-linked inherited lysosomal storage disease that is caused by α-galactosidase A gene variants resulting in progressive accumulation of pathogenic glycosphingolipid (Gb3) accumulation in multiple tissues and organs, Fabry disease (FD) can be classified into classic or late-onset phenotypes. In classic phenotype patients, α-galactosidase A activity is absent or severely reduced, resulting in a more progressive disease course with multi-systemic involvement. Conversely, late-onset phenotype, often with missense variants (e.g., IVS4+919G>A) in Taiwan, may present with a more chronic clinical course with predominant cardiac involvement (cardiac subtype), as they tend to have residual enzyme activity, remaining asymptomatic or clinically silent during childhood and adolescence. In either form, cardiac hypertrophy remains the most common feature of cardiac involvement, potentially leading to myocardial fibrosis, arrhythmias, and heart failure. Diagnosis is established through α-galactosidase enzyme activity assessment or biomarker analyisis (globotriaosylsphingosine, Lyso-Gb3), advanced imaging modalities (echocardiography and cardiac magnetic resonance imaging), and genotyping to differentiate FD from other cardiomyopathy. Successful therapeutic response relies on early recognition and by disease awareness from typical features in classic phenotype and cardiac red flags in cardiac variants for timely therapeutic interventions. Recent advances in pharmacological approach including enzyme replacement therapy (agalsidase alfa or beta), oral chaperone therapy (migalastat), and substrate reduction therapy (venglustat) aim to prevent from irreversible organ damage. Genotype- and gender-based monitoring of treatment effects through biomarker (Lyso-Gb3), renal assessment, and cardiac responses using advanced imaging modalities are key steps to optimizing patient care in FD.

01 Jul 2024·Advances in Therapy

Qualitative Study of the Patient Experience with Venglustat for Gaucher Disease Type 3 in a Phase 2 Open-Label, Multicenter, Multinational Study (LEAP)

Article

Author: Zheng, Riliang ; Mengel, Eugen ; Wallace, Mary ; Gwaltney, Chad ; Schiffmann, Raphael ; Pulikottil-Jacob, Ruth ; Krupnick, Robert ; Batsu, Isabela ; Turnbull, James ; Hamed, Alaa ; Rochmann, Camille

INTRODUCTIONGaucher disease type 3 (GD3) is a genetic, progressive lysosomal storage disorder characterized by visceral manifestations and chronic neurologic symptoms (e.g., horizontal ophthalmoplegia/supranuclear gaze palsy, ataxia, dystonia). The investigational agent venglustat is being studied in combination with imiglucerase as potential treatment for systemic and neuronopathic manifestations of GD3 in a single-arm, open-label, phase 2 trial (LEAP; N = 11). To understand perceived changes in GD3 symptoms from the perspectives of patients, caregivers, and clinicians, we conducted a qualitative case study of selected LEAP participants.METHODSFour patients in LEAP (age range, 20-28 years), four of their caregivers, and three clinicians involved in LEAP were interviewed individually by moderators using semi-structured guides. Clinicians' perceptions were based on observation of interviewed patients and those in LEAP who were not interviewed, as well as information provided by other staff involved in LEAP, patients, and caregivers.RESULTSReported changes in GD3 symptoms varied among patients and among reporters. Only eye movement was spontaneously mentioned as improved by at least one patient, caregiver, and clinical expert. Symptom improvement also varied in terms of time to improvement. Within the first weeks, improvements were seen in understanding new information or complex instructions, remembering the weekday, eye movement, tremor, and seizures. Changes in alertness, engagement and responsiveness, memory, and concentration appeared after months or a year. Most caregivers and all clinical experts reported greater patient independence (e.g., increased ability to perform activities of daily living or travel independently during the trial) as a perceived treatment effect on a GD3 impact. For one patient who perceived benefits from venglustat therapy, pharmacokinetic analyses during LEAP found low to undetectable venglustat levels in their plasma and cerebrospinal fluid.CONCLUSIONOutcomes from this study provide insights into GD3 symptoms and the early signaling of changes reported during venglustat therapy.TRIAL REGISTRATIONClinicalTrials.gov identifier, NCT02843035.

News (Medical) associated with Ibiglustat

25 Apr 2024

·www.fiercebiotech.com

Sanofi crosses Sjögren's off $5B drug's hit list after phase 2 data disappoint

Sanofi revealed a setback alongside news of another blow to venglustat. Sanofi is narrowing development of one of its 5 billion euro ($5.4 billion), “pipeline-in-a-product” assets. The French drugmaker axed Sjögren’s syndrome from the list of targeted indications for frexalimab after seeing phase 2 efficacy data—and reported a phase 3 flop for one of its tarnished former top prospects. Frexalimab is a CD40L monoclonal antibody that cleared a midphase test in multiple sclerosis (MS) last year. The readout suggested Sanofi may have found a way around the blood clot risks that blighted earlier CD40 drug candidates. Encouraged, Sanofi pushed ahead with phase 3 studies in two forms of MS and midstage trials in Type 1 diabetes and systemic lupus erythematosus. The company began comparing frexalimab, also known as SAR441344, to placebo in Sjögren’s in 2020. The goal was to show whether the candidate can improve scores on a Sjögren’s disease activity scale. Sanofi revealed the molecule fell short as part of its first-quarter results (PDF) Thursday. “The data confirmed pharmacologic activity and well-tolerated safety profile but not the necessary efficacy outcomes to continue to move forward the development in this indication,” Sanofi said. The findings of the 84-patient phase 2 trial persuaded Sanofi to stop development in Sjögren’s. Development in other, potentially more lucrative indications is continuing. Sanofi revealed the setback alongside news of another blow to venglustat, a GCS inhibitor that has slipped down the pecking order in recent years. Venglustat was among the assets that Paul Hudson identified as Sanofi's top prospects when he took over as CEO in 2019. However, the drugmaker stopped a phase 2/3 trial in autosomal dominant polycystic kidney disease in 2021. The failure came months after venglustat missed the mark in a phase 2 Parkinson’s disease study. While the failures dented Sanofi’s “pipeline in a pill” ambitions, work continued in GM2 gangliosidosis, Gaucher disease type 3 and Fabry disease. Thursday, Sanofi crossed GM2 off the list of active indications “based on the absence of positive trends on clinical endpoints.” Sanofi said the phase 3 GM2 trial “reinforced the favorable safety profile” of venglustat. Development is continuing in Fabry and Gaucher, settings in which Sanofi could file for approval in 2025 and beyond.

Phase 3Phase 2Clinical Trial Failure

25 Apr 2024

·firstwordpharma.com

All eyes on Dupixent decision in COPD as Sanofi suffers further pipeline setbacks

Sanofi said Thursday that Dupixent remains on track to record sales of around €13 billion this year after posting strong growth in the first quarter ahead of an expected expansion into chronic obstructive pulmonary disease. Revenue from Dupixent jumped 22.4% in the three-month period to €2.8 billion.The performance of Dupixent, along with Beyfortus (€182 million) and Altuviiio (€122 million), helped the company top expectations, with overall sales rising 2.4% to €10.5 billion, ahead of forecasts of €10.3 billion. However, net income plunged 43.2% to €1.1 billion.Sanofi reiterated its expectation that earnings this year will decrease by a low single-digit percentage at constant currencies. CEO Paul Hudson has braced investors for a period of slower growth over the next few years as the company directs resources into its drug-development, betting on 12 pipeline medicines including amlitelimab, frexalimab and tolebrutinib that it says have blockbuster potential.Pipeline setbacksHowever, Sanofi’s ambitions for frexalimab took a hit on Thursday after the company disclosed that development in Sjögren’s syndrome has been halted. Results from a Phase II trial failed to meet the “necessary efficacy outcomes” to continue to work in this indication, the drugmaker said, noting that Phase III studies of the anti-CD40L antibody in relapsing multiple sclerosis and secondary-progressive multiple sclerosis will continue, as well as mid-stage development in type 1 diabetes and systemic lupus erythematosus.Sanofi also disclosed Thursday that the Phase III AMETHIST trial of the GCS inhibitor venglustat for the treatment of GM2 gangliosidosis was discontinued based on “the absence of positive trends” for clinical endpoints. The company also confirmed the discontinuation of the RIPK1 inhibitor oditrasertib - announced by partner Denali Therapeutics in February – in amyotrophic lateral sclerosis.More to come.

Phase 2Phase 3Financial StatementClinical Trial FailureDrug Approval

25 Apr 2024

·www.biospace.com

Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1

Pictured: Exterior of Sanofi's U.S. headquarters in Bridgewater, N.J./ iStock/JHVEPhoto On Thursday, European drugmakers Sanofi and AstraZeneca announced several pipeline cuts in their respective first-quarter 2024 financial results, including assets to treat Sjögren’s syndrome and cardiovascular disease. According to Sanofi’s first-quarter results, the development of the CD40L antibody frexalimab in Sjögren’s syndrome was halted due to unfavorable Phase II study data. While Sanofi touted the safety and “pharmacologic activity” of the drug, the candidate did not reach the “necessary efficacy outcomes” to move forward. However, frexalimab will continue on in Phase III trials in multiple sclerosis (RMS) and secondary-progressive multiple sclerosis (SPMS) as well as Phase II trials in type 1 diabetes and systemic lupus erythematosus. In February 2024, frexalimab secured positive mid-stage results in RMS demonstrating a slowing in disease activity. The drug is also one of Sanofi’s “pipeline-in-a-product” assets that the company contends can potentially generate annual sales of €5 billion ($5.3 billion). Sanofi is also halting a Phase II study of the molecule venglustat to treat the rare genetic disorder GM2 gangliosidosis. The company said there was an “absence of positive trends” for its clinical endpoints in the trial. The molecule aims to slow disease progress by inhibiting the abnormal accumulation of glycosphingolipids. In 2021, Sanofi stopped a Phase II/III trial of venglustat in kidney disease as it did not reach the futility criteria. In neurology, Sanofi discontinued a Phase II study of the RIPK1 inhibitor oditrasertib in amyotrophic lateral sclerosis (ALS) as the trial failed to reach the primary endpoint of improvement based on the ALS Functional Rating Scale-Revised. Sanofi said it will share the complete safety and efficacy data at an upcoming medical meeting and continue the Phase II study of oditrasertib in MS patients. Sanofi’s pipeline cuts come amid announced layoffs last week as part of the company’s restructuring of its U.S. vaccine operations. Thursday’s Q1 earnings also saw AstraZeneca putting the kibosh on several early-stage medicines, including MEDI6570, designed to block multiple ligands to the LOX-1 receptor. The asset was in a Phase IIb trial, called GOLDILOX, for post-myocardial infarction but was stopped due to a “strategic portfolio prioritization.” Other AstraZeneca assets nixed for portfolio prioritization include the metabolic dysfunction-associated steatohepatitis (MASH) candidate AZD7503. The ligand-conjugated antisense (LICA) drug originally belonged to Ionis Pharmaceuticals and is designed to inhibit the production of hydroxysteroid 17-beta dehydrogenase 13 (HSD17B13). The other asset to get axed is the oral porcupine inhibitor AZD5055, which was in Phase I trials for Idiopathic pulmonary fibrosis (IPF) and other Interstitial lung diseases (ILDs) with progressive fibrosis. The candidate was picked up from Redx Pharma in 2020 for $17 million and $360 million, respectively, in potential milestone payments. For Sanofi’s Q1 results, the pharma reported over €10.4 billion ($11.2 billion) in sales, driven by its blockbuster drug Dupixent which increased 24.9% compared to the same period. AstraZeneca meanwhile pulled in $12.1 billion in sales for the quarter, a 15% boost from Q1 of 2023, with its oncology products bringing in more than $5.1 billion, a 23% bump from the previous quarter. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Phase 2Phase 1AcquisitionFinancial StatementClinical Result

100 Deals associated with Ibiglustat

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gangliosidoses, GM2	Phase 3	-	Sanofi-Aventis Recherche et Développement SA	-
Polycystic Kidney, Autosomal Dominant	Preclinical	IT	Sanofi-Aventis Recherche et Développement SA	04 Oct 2018
Polycystic Kidney, Autosomal Dominant	Preclinical	IT	Sanofi (China) Investment Co. Ltd.	04 Oct 2018
Polycystic Kidney, Autosomal Dominant	Preclinical	GB	Genzyme Corp.	04 Oct 2018
Polycystic Kidney, Autosomal Dominant	Preclinical	CZ	Genzyme Corp.	04 Oct 2018
Polycystic Kidney, Autosomal Dominant	Preclinical	DK	Genzyme Corp.	04 Oct 2018
Gaucher Disease, Type 3	Preclinical	SE	Sanofi-Aventis Recherche et Développement SA	04 Jan 2017
Gaucher Disease, Type 3	Preclinical	SE	Genzyme Corp.	04 Jan 2017
Gaucher Disease, Type 3	Preclinical	SE	Sanofi Winthrop Industrie SA	04 Jan 2017
Gaucher Disease, Type 3	Preclinical	SE	Sanofi (China) Investment Co. Ltd.	04 Jan 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04705051 (STAGED-PKD-EXT, CTgov)	Phase 3	Polycystic Kidney, Autosomal Dominant	24	Venglustat	mqbvskiwrw(horyscqzjf) = mvjsnusxkp zkoiciihwg (bubxbwhrik, hvjwhmesqg - cjbhhzbhzx) View more	-	06 Oct 2022
NCT04221451 (AMETHIST, SSIEM2022)	Phase 3	Gangliosidoses, GM2	75	Venglustat	njrckdfmhx(gzrrkmpgss) = kjycfoeydo rgxztjotqg (ydjxyyjggi ) View more	-	30 Aug 2022
NCT02906020 (MOVES-PD, MDS2020)	Phase 2	Hypotension, Orthostatic GBA mutation	196	Venglustat	gazqfbtokf(cxgshtiyas) = bsgtaqaoxe bvdckhoyxp (nhdfatallb, 7 - 94) View more	Positive	12 Sep 2020
NCT02906020 (MOVES-PD, MDS2020)	Phase 2	Hypotension, Orthostatic GBA mutation	196	Placebo	(squkxrefet) = curdkylgtn zypaseavdo (zmjirjzgrg )	Positive	12 Sep 2020
NCT02489344 \| NCT02228460 (ERA2020)	Phase 2	Fabry Disease plasma GL-3 \| eGFR	11	Venglustat	vqaaviemlt(kwbqibtwrq) = klcmdjuxba qjqfzcpevm (vkiedibzog )	Positive	06 Jun 2020
NCT02489344 \| NCT02228460 (ERA2020)	Phase 2	Fabry Disease plasma GL-3 \| eGFR	11	Placebo	vqaaviemlt(kwbqibtwrq) = nktclnwbaj qjqfzcpevm (vkiedibzog )	Positive	06 Jun 2020
NCT02906020 (MOVES-PD, EAN)	Phase 2	Young onset Parkinson disease GBA mutations	29	Venglustat	(hzotzvzzrz) = wekzysaqne kpjohqionl (mycxypeifu )	Positive	22 May 2020
NCT02906020 (MOVES-PD, EAN)	Phase 2	Young onset Parkinson disease GBA mutations	29	Placebo	(hzotzvzzrz) = ywtsjayajv kpjohqionl (mycxypeifu )	Positive	22 May 2020
NCT02228460 (CTgov)	Phase 2	Fabry Disease	11	GZ/SAR402671	liypmeecay(vhntuyzpjq) = rbdwoiroih gwxegjjllf (dttpcaumjq, ozyntjtgzh - mxkgbznhna) View more	-	17 Dec 2019
NCT02489344 (CTgov)	Phase 2	Fabry Disease	8	GZ/SAR402671	uxwztunjhn(bgqgfrsgps) = qhxrtwkglc oofpxmqhlq (tbnxtwezbu, tucpmbdyzc - ibimkozczt) View more	-	09 Dec 2019

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