This is a global, multicenter, prospective, observational registry of patients with Pompe disease, including those with late-onset pompe disease (LOPD) and infantile-onset pompe disease (IOPD). Both untreated patients and those being treated with an approved therapy for Pompe disease are eligible to participate.
The objectives of the registry are:
To evaluate the long-term safety of Pompe disease treatments through collection of data that describe the frequency of adverse events (AEs)/serious adverse events (SAEs) occurring in Pompe disease patients
To evaluate the long-term real-world effectiveness of Pompe disease treatments
To evaluate the long-term real-world impact of Pompe disease treatments on quality of life (QOL) and patient-reported outcomes (PROs)
To describe the natural history of untreated Pompe disease

Start Date16 Feb 2024

Sponsor / Collaborator

Amicus Therapeutics, Inc.

NCT04848779 / RecruitingNot Applicable

A Prospective Observational Study to Describe Clinical Outcomes of Alglucosidase Alfa Treatment in Patients ≤6 Months of Age With Infantile-onset Pompe Disease (IOPD)

Primary Objective:
To describe the effect of routine practice with alglucosidase alfa in patients with IOPD ≤6 months of age, on invasive ventilation-free survival after 52 weeks of treatment.
Secondary Objectives:
To describe the effect of routine practice with alglucosidase alfa on invasive ventilation-free survival and survival at 12 and 18 months of age, as well as on change in left ventricular mass (LVM) Z score, Alberta Infant Motor Scale (AIMS) score, body weight, body length, and head circumference Z scores, and urinary glucose tetrasaccharide (Hex4), at Week 52 of treatment.
To describe the safety, tolerability, and immunogenicity of alglucosidase alfa in the routine practice of IOPD treatment.

Start Date10 Jun 2021

Sponsor / Collaborator

Sanofi SA

CTR20200942 / Active, not recruitingPhase 4

评估中国晚发型庞贝病患者接受阿糖苷酶α治疗的有效性和安全性的一项单组、前瞻性、开放性、多中心研究

[Translation] A single-group, prospective, open-label, multicenter study to evaluate the efficacy and safety of alglucosidase alfa in Chinese patients with late-onset Pompe disease

主要目的：评价5岁以上中国晚发型庞贝病患者接受阿糖苷酶α治疗对运动功能[6分钟步行测试(6MWT)和肺功能预测用力肺活量(FVC)]的影响。评价美而赞20 mg/kg，每两周一次在中国3岁以上LOPD患者中的安全性。次要目的：评价5岁以上的LOPD患者接受阿糖苷酶α治疗对徒手肌力测试(MMT)、最大吸气压和最大呼气压（MIP和MEP）、快速运动功能测试评分以及健康相关生活质量(SF-12)改善的影响。

[Translation]

Primary objective: To evaluate the effect of alglucosidase alfa treatment on motor function [6-minute walk test (6MWT) and forced vital capacity (FVC) predicted by lung function] in Chinese patients with late-onset Pompe disease aged 5 years and above. To evaluate the safety of Merzoglan 20 mg/kg once every two weeks in Chinese patients with LOPD aged 3 years and above. Secondary objective: To evaluate the effect of alglucosidase alfa treatment on improvement of manual muscle test (MMT), maximum inspiratory pressure and maximum expiratory pressure (MIP and MEP), rapid motor function test score and health-related quality of life (SF-12) in patients with LOPD aged 5 years and above.

Start Date10 Mar 2021

Sponsor / Collaborator

Genzyme Europe BV

[+3]

100 Clinical Results associated with Alglucosidase Alfa

100 Translational Medicine associated with Alglucosidase Alfa

100 Patents (Medical) associated with Alglucosidase Alfa

1,610

Literatures (Medical) associated with Alglucosidase Alfa

01 Mar 2024·Journal of pharmaceutical and biomedical analysis

UPLC-Q-TOF/MS based serum and urine metabolomics strategy to analyze the mechanism of nervonic acid in treating Alzheimer’s disease

Article

Author: Chen, Ziyi ; Wang, Rongjin ; Wang, Meiyuan ; Liu, Zhongying ; Liu, Shu ; Zhou, Hui ; Pei, Shuhua

Nervonic acid is a natural component of breast milk and is frequently used as a food additive due to its excellent neuroprotective effects. Although it has been reported that nervonic acid may play a role in the recovery of human cognitive impairment, its specific mechanism of action is still unclear. In this study, the results of serum biochemical indexes showed that nervonic acid improved inflammation and reduced amyloid β peptide (Aβ) deposition and tau protein phosphorylation in Alzheimer's disease (AD) rats. Subsequently, we further used a metabolomics approach to investigate the potential mechanism of action of nervonic acid in the treatment of AD. The results of serum and urine metabolomics study showed that the intervention of nervonic acid significantly reversed the metabolic profile disorder in AD rats. A total of 52 metabolites were identified. They mainly involved linoleic acid metabolism, alpha-linolenic acid metabolism, phenylalanine metabolism and arachidonic acid metabolism, and all these metabolic pathways were associated with the emergence of inflammation in vivo. It suggests that the therapeutic effect of nervonic acid on AD is likely to be produced by ameliorating inflammation. The results obtained in this study provide new insights into the mechanism of nervonic acid treatment of AD and lay a foundation for the clinical application of nervonic acid in the treatment of Alzheimer's disease.

01 Feb 2024·Molecular genetics and metabolism

Effect of avalglucosidase alfa on disease-specific and general patient-reported outcomes in treatment-naïve adults with late-onset Pompe disease compared with alglucosidase alfa: Meaningful change analyses from the Phase 3 COMET trial

Article

Author: Dimachkie, Mazen M ; Zhou, Tianyue ; Msihid, Jérôme ; Pollissard, Laurence ; Thibault, Nathan ; Toscano, Antonio ; van der Beek, Nadine ; Schoser, Benedikt ; Kishnani, Priya S ; Hamed, Alaa ; Berger, Kenneth I ; Haack, Kristina An ; DasMahapatra, Pronabesh

BACKGROUND:

The Phase 3 COMET trial (NCT02782741) comparing avalglucosidase alfa and alglucosidase alfa included health-related quality of life (HRQoL) assessments in treatment-naïve patients with late-onset Pompe disease (LOPD). Here, we further characterize results from disease-specific and general patient-reported outcome (PRO) measures.

METHODS:

Adults who participated in the COMET trial receiving avalglucosidase alfa or alglucosidase alfa (both 20 mg/kg biweekly) during the 49-week double-blind treatment period were included in the analysis. Proportions of patients exceeding meaningful change thresholds at Week 49 were compared post hoc between treatment groups. PROs and their meaningful change thresholds included: Pompe Disease Severity Scale (PDSS; decrease 1.0-1.5 points), Pompe Disease Impact Scale (PDIS; decrease 1.0-1.5 points), Rasch-built Pompe-specific Activity Scale (R-PAct; change from unable to able to complete activity), 12-item Short Form Health Survey (SF-12; physical component summary [PCS] score: increase ≥6 points, mental component summary [MCS] score: increase ≥7 points), EuroQol 5 Dimension 5 Level (EQ-5D-5L; improvement of ≥1 category), and Patient Global Impression of Change (PGIC; any improvement).

RESULTS:

The analysis included 99 adult patients (avalglucosidase alfa n = 50; alglucosidase alfa n = 49). Patients who received avalglucosidase alfa had significantly greater odds of achieving a meaningful change versus alglucosidase alfa for the PDSS Shortness of Breath (OR [95% CI] 11.79 [2.24; 62.18]), Fatigue/Pain (6.24 [1.20; 32.54]), Morning Headache (13.98 [1.71; 114.18]), and Overall Fatigue (5.88 [1.37; 25.11]) domains, and were significantly more likely to meet meaningful change thresholds across multiple PDSS domains (all nominal p < 0.05). A numerically greater proportion of patients in the avalglucosidase alfa group were able to complete selected activities of the R-PAct compared with the alglucosidase alfa group. Significantly greater proportions of patients who received avalglucosidase alfa achieved meaningful improvements for EQ-5D-5L usual activities dimension, EQ visual analog scale, and all four PGIC domains. The proportion of patients with improvements in SF-12 PCS and MCS was greater in the avalglucosidase alfa group versus alglucosidase alfa group, but was not significant (p > 0.05).

CONCLUSIONS:

These analyses show that avalglucosidase alfa improves multiple symptoms and aspects of daily functioning, including breathing and mobility. This supports the clinical relevance of the effects of avalglucosidase alfa on HRQoL for patients with LOPD.

01 Feb 2024·Gene

Integrated analysis of miRNA, transcriptome, and degradome sequencing provides new insights into lipid metabolism in perilla seed

Article

Author: Lu, Minting ; Zhang, Ke ; Wang, Hongbin ; Shen, Qi ; Wu, Duan ; Zou, Xiuzai

MicroRNAs (miRNA) are small noncoding RNAs that play a crucial as molecular regulators in lipid metabolism in various oil crops. Perilla (Perilla frutescens) is a specific oil crop known for its high alpha-linolenic acid (C18:3n3, ALA) content (>65 %) in their seed oils. In view of the regulatory mechanism of miRNAs in perilla remains unclear, we conducted miRNAs and transcriptome sequencing in two cultivars with distinct lipid compositions. A total of 525 unique miRNAs, including 142 differentially expressed miRNAs was identified in perilla seeds. The 318 miRNAs targeted 7,761 genes. Furthermore, we identified 112 regulated miRNAs and their 610 target genes involved in lipid metabolism. MiR159b and miR167a as the core nodes to regulate the expression of genes in oil biosynthesis (e.g., KAS, FATB, GPAT, FAD, DGK, LPAAT) and key regulatory TFs (e.g., MYB, ARF, DOF, SPL, NAC, TCP, and bHLH). The 1,219 miRNA-mRNA regulation modules were confirmed through degradome sequencing. Notably, pf-miR159b-MYBs and pf-miR167a-ARFs regulation modules were confirmed. They exhibited significantly different expression levels in two cultivars and believed to play important roles in oil biosynthesis in perilla seeds. This provides valuable insights into the functional analysis of miRNA-regulated lipid metabolism in perilla seeds.

News (Medical) associated with Alglucosidase Alfa

03 Jun 2024

·www.biospace.com

YourChoice Therapeutics Completes Phase 1a Clinical Study for First Hormone-Free Male Birth Control Pill

Successful first-in-human study shows YCT-529 is safe SAN DIEGO--(BUSINESS WIRE)-- 2024 BIO International Convention—YourChoice Therapeutics, Inc., pioneering hormone-free family planning products, has completed its first-in-human clinical study for YCT-529, designed to be the first hormone-free birth control pill for men. YourChoice Therapeutics CEO Akash Bakshi will present the results of the phase 1a study at the 2024 BIO International Convention on June 4 at 10:45 PDT. “We’re one step closer to delivering the world’s first male birth control pill,” said YourChoice Therapeutics chief science officer Nadja Mannowetz. “While the road to FDA approval for any new drug candidate is long, we’re very pleased with the speed, efficiency, and enthusiasm for YCT-529’s first-in-human study. The findings are powerful validation that YCT-529 is safe and well tolerated in men and lays a favorable foundation for further studies.” Innovation in birth control has been stagnant since the female birth control pill (“the Pill”) debuted 65 years ago. Since then, all new birth control options, except for the copper IUD, have relied on dosing women with hormones to prevent pregnancy. Importantly, there have been no new options for men, reinforcing the view that pregnancy prevention is “a woman’s job.” A birth control pill for men that’s hormone-free is a transformative innovation for a very deserving healthcare segment. In YCT-529’s phase 1a study, researchers studied doses up to 180 mgs, finding that all were safe and well tolerated. The next study will investigate multiple ascending doses (MAD) in a larger participant pool. YCT-529’s preclinical studies showed it was 99% effective and 100% reversible with no side effects. “The Pill turns 65 next year, marking more than a half-century of hormonal birth control with no new options for men to reduce the hormonal burden on their partners,” said Stewart McCallum, MD FACS, chief medical Officer for YourChoice Therapeutics, Inc. “This lack of modernization would be unacceptable in any area of healthcare and motivates us to advance YCT-529, which is on track to be the first hormone-free male birth control pill. The success of our phase 1a study is an important milestone on the path to delivering innovation in birth control that will benefit men and women alike.” YCT-529 is a retinoic acid receptor-alpha (RAR-alpha) inhibitor, which prevents sperm production by blocking access to vitamin A in the testes. Researchers discovered this mechanism of action in the 1930s after discovering that depriving mice, rats, and monkeys of vitamin A caused infertility. Since that time, decades of published studies have validated the pathway. “Women’s narrowing reproductive rights offer potent fuel to the fire driving male contraceptive candidates,” said YCT-529 Developer Gunda Georg, regents professor at the University of Minnesota’s College of Pharmacy and founding director of the Institutes for Therapeutics Discovery and Development. “Numerous published studies and surveys show that the world wants and needs more male contraceptive options. We also can’t deny that women are tired of bearing the burden of hormones. I’m very pleased by the speed and efficiency of YCT-529’s first-in-human study and feel confident that future studies will demonstrate similar success. Society is ready for a male contraceptive, and we applaud the organizations that recognize this and support our efforts to deliver the first hormone-free male birth control pill.” Quotient Sciences, based in the UK, conducted the phase 1a study, which began in December 2024. About YCT-529 Researchers have understood for decades that vitamin A is essential for male fertility. YCT-529 is a retinoic acid receptor-alpha (RAR-a) inhibitor that prevents production of sperm cells in the testes as well as their release by blocking RAR-alpha (one of three nuclear receptors that bind retinoic acid, a form of vitamin A). Preclinical studies have shown that YCT-529 is 99% effective at preventing mouse pregnancies and 100% reversible. YourChoice Therapeutics developed YCT-529 in collaboration with Dr. Gunda Georg, a globally recognized medicinal chemist and awardee of one of the largest NIH-funded Contraceptive Centers. The Male Contraceptive Initiative (MCI) has been committed to funding the early research and YCT-529’s phase one clinical trial in men. More information about the trial can be found at clinicaltrials.gov, NCT06094283. About YourChoice Therapeutics YourChoice Therapeutics is a clinical-stage biopharmaceutical company developing the first hormone-free birth control pill for men. Based in San Francisco, the company is advancing the only male pill in human studies. Preclinical studies showed YCT-529 performed as effectively or better than the female birth control pill. Future programs will apply the company’s patented therapeutic platform to develop hormone-free family planning products for women. Established in 2018, the company received a $15M Series A investment in 2022. For more information, visit and follow the company on LinkedIn.

Phase 1Phase 2

10 May 2024

·firstwordpharma.com

After scuppered Sanofi deal, Maze navigates its way to new partner for Pompe drug

Maze Therapeutics looks to have found another partner for its investigational Pompe disease drug MZE001 after a deal last year with Sanofi fell foul of antitrust regulators. In an agreement announced on Friday, Maze will receive $150 million upfront from Shionogi and is eligible for additional milestones payments and tiered sales royalties.Sanofi abandoned its plans to license the Maze molecule in December under a deal potentially worth $750 million, including $150 million upfront, after the US Federal Trade Commission (FTC) raised competition concerns. The French drugmaker already markets the Pompe disease enzyme replacement therapies Lumizyme (alglucosidase alfa), also known as Myozyme, and Nexviazyme (avalglucosidase alfa), which are both administered via biweekly intravenous infusions.Meanwhile, Shionogi is looking to strengthen its rare diseases portfolio as part of its revised medium-term business strategy. “The science behind MZE001 is differentiated and promising,” with the potential to serve as “both mono and add-on therapy to enzyme replacement therapies,” remarked Shionogi CEO Isao Teshirogi. MZE001, an oral inhibitor of GYS1, is designed to restrict glycogen accumulation in patients with Pompe disease. The drug’s Phase I data released in February last year confirmed target engagement, prompting Maze to finalise mid-stage development. As part of the deal for MZE001, Shionogi will also have global rights to related programmes and intellectual property.

Phase 1

19 Mar 2024

·www.biospace.com

YourChoice Therapeutics Scientific Advisory Board member updates phase 1a study for male birth control candidate at ACS Spring 24

Gunda Georg delivered phase 1a study details at the American Chemical Society Meeting SAN FRANCISCO--(BUSINESS WIRE)-- YourChoice Therapeutics, a San Francisco biotech startup developing the first hormone-free male birth control pill, announced today that Gunda Georg, YCT-529’s co-inventor, provided an update on its phase 1a clinical study for the first hormone-free male birth control pill, YCT-529, at the American Chemical Society (ACS) 2024 Spring Meeting. The ACS meeting is being held in New Orleans and concludes on March 21, 2024. Dr. Georg provided details about YCT-529, a drug discovered in her group that has progressed into a phase 1 study, which began in December 2023. Her presentation, “Discovery and development of a male pill: Are we finally getting there?” was on March 18. The phase 1a study investigates the safety, tolerability, pharmacokinetics, and pharmacodynamics of single, ascending oral doses of YCT-529 in 16 participants. YourChoice Therapeutics expects to complete the study by mid-2024. “The phase 1a study for YCT-529 is progressing well,” said Gunda Georg, PhD, Regents Professor at the University of Minnesota’s College of Pharmacy and founding director of the Institutes for Therapeutics Discovery and Development. “March is the mid-point of the study. It’s also Women’s History Month, creating an opportunity to highlight the need for contraceptive equity. The future of pregnancy prevention is shared responsibility. I’m pleased to be a part of that future.” YCT-529 is a hormone-free birth control candidate currently under investigation. It prevents sperm production by blocking access to a form of vitamin A, called retinoic acid, in the testes. Multiple independent studies validate the mechanism of action, which researchers identified decades ago. Preclinical studies in mice showed that YCT-529 was as effective or better than the human female birth control pill in preventing pregnancies and 100% reversible without side effects. “Men and women want more birth control options, and they want them to be hormone-free,” said Akash Bakshi, co-founder and CEO of YourChoice Therapeutics. “Gunda’s work to deliver the first hormone-free birth control pill is ground-breaking and could shepherd a transformative—and much needed—shift toward shared responsibility, choice, and reproductive equality. Men want to help, and we’re working collaboratively with Gunda to give them more options to do so.” About YCT-529 Researchers have understood for decades that vitamin A is essential for male fertility. YCT-529 is a retinoic acid receptor-alpha (RAR-alpha) inhibitor that prevents the production of sperm cells in the testes as well as their release by blocking RAR-alpha (one of three nuclear receptors that bind retinoic acid, a form of vitamin A). Several preclinical studies have shown that YCT-529 is 99% effective at preventing mouse pregnancies and 100% reversible. YourChoice Therapeutics developed YCT-529 in collaboration with Dr. Gunda Georg, a globally recognized medicinal chemist, and awardee of one of the largest NIH-funded Contraceptive Centers. The Male Contraceptive Initiative (MCI) has been committed to funding the early research and YCT-529’s Phase 1a clinical trial in men, which is underway at Quotient Sciences in the UK. More information about the trial can be found at clinicaltrials.gov, NCT06094283. About YourChoice Therapeutics YourChoice Therapeutics is an early-stage biopharmaceutical company focused on developing the first hormone-free birth control pill for men. Based in San Francisco, the company is currently studying YCT-529 in a Phase 1a clinical trial. In preclinical studies, YCT-529 performed as effectively or better than the female birth control pill. Future programs will apply the company’s patented therapeutic platform to develop hormone-free family-planning products for women. Established in 2018, the company raised a $15M Series A in 2022. For more information, visit and follow the company on LinkedIn.

Phase 1Phase 2

100 Deals associated with Alglucosidase Alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D03207	Alglucosidase Alfa	A16AB07	DB01272

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Glycogen Storage Disease Type II	EU	Sanofi	28 Mar 2006
Glycogen Storage Disease Type II	IS	Sanofi	28 Mar 2006
Glycogen Storage Disease Type II	LI	Sanofi	28 Mar 2006
Glycogen Storage Disease Type II	NO	Sanofi	28 Mar 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00486889 (CTgov)	Phase 4	Glycogen Storage Disease Type II	12	alglucosidase alfa	mptgbofihb(qzkchqqvop) = ljfhqvfopp xipfsueqfy (vkupklcfqe, sruvzffluo - tejzruvtsk) View more	-	26 Aug 2022
NCT03687333 (APOLLO-IOPD, PRNewswire) Manual	Phase 4	Glycogen Storage Disease Type II	10	Alglucosidase Alfa	chlvdpzgfv(nqgqseqkap) = dyazfbzctc dkwqxwlcho (vabmfjfedr, 39.93) View more	Positive	05 Aug 2022
NCT03687333 (APOLLO-IOPD, Pubmed) Manual	Phase 4	Glycogen Storage Disease Type II	10	Alglucosidase Alfa	lylifulpft(ycplskyvho) = qfxbndroqn vyxnxrupbp (wggblhkbgj, 155.99) View more	Positive	27 Jun 2022
NCT01410890 (CTgov)	Phase 4	Glycogen Storage Disease Type II	21	Alglucosidase Alfa (Alglucosidase Alfa: <18 Years)	cgvoslopvf(tgfavgacfo) = yatcbcbuih czsjhumygi (khpnmdehqv, wcufultthe - ukifknujxz) View more	-	11 Jun 2021
				Alglucosidase Alfa (Alglucosidase Alfa: >=18 Years)	cgvoslopvf(tgfavgacfo) = sobpsntokz czsjhumygi (khpnmdehqv, jabharsazw - dyyibhjjup) View more
NCT00701701 (CTgov)	Phase 4	Glycogen Storage Disease Type II	4	Myozyme® (alglucosidase alfa) (Regimen A: Alglucosidase Alfa and Cyclophosphamide)	jwouneptyb(klxtzdotzv) = eetphxpyfd niovpqqgow (qedlywdlbc, gzxhqkwtpc - osyzabxtyf) View more	-	12 Oct 2020
				Myozyme® (alglucosidase alfa) (Regimen B: Alglucosidase Alfa, Rituximab and Methotrexate)	jwouneptyb(klxtzdotzv) = gpsvsfjeiy niovpqqgow (qedlywdlbc, ybrtdaeuxt - fywujdwhgv) View more
NCT01526785 (Pubmed) Manual	Phase 4	Glycogen Storage Disease Type II	113	Alglucosidase alfa (IOPD)	inhilrkgcj(tiyzvvdwei) = gzdiqjisql gabtwrnveq (zioskvkynm ) View more	Positive	01 Oct 2018
				Alglucosidase alfa (LOPD)	inhilrkgcj(tiyzvvdwei) = uknojspjpm gabtwrnveq (zioskvkynm ) View more
NCT01380743 (CTgov)	Phase 2	Glycogen Storage Disease Type II	25	rhGAA+duvoglustat (Cohort 1, Duvoglustat 50 mg + rhGAA)	onfprplvlx(bhbygysowv) = snmeaniiqt xbpnkgydsh (wikwcgluls, stzaadhqzq - qwqndmzfte) View more	-	17 Aug 2018
				rhGAA+duvoglustat (Cohort 2, Duvoglustat 100 mg + rhGAA)	onfprplvlx(bhbygysowv) = lpztxvyewx xbpnkgydsh (wikwcgluls, krvfixgfqr - qtkwyhvsxj) View more
LOTS (AAN2017)	Not Applicable	Glycogen Storage Disease Type II	68	Alglucosidase alfa	zjcsawxqcr(ylkwgsxazo) = ziljepnwag hunavsfznc (ipgsylciup ) View more	Positive	18 Apr 2017
NCT01597596 (CTgov)	Phase 4	Glycogen Storage Disease Type II	4	alglucosidase alfa (Alglucosidase Alfa 4000 L Material (Non-US Participants))	kgqccedyim(degdynxedy) = omrhijbqls gebhbqlakn (wazyjiegyp, lkmvvumnoz - pywgvbxxmv) View more	-	18 Jan 2016
				alglucosidase alfa (Alglucosidase Alfa 160 L Material (US Participants))	wjqgauzmge(skypoxgzms) = jlgmfnpckp uwgezrmdrt (rmlwtvryqr, pvbmokltjh - savhqwrrin) View more

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