CLINICAL TRIALS PROFILE FOR GERMA-MEDICA MG

All Clinical Trials for Germa-medica Mg

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00270829 ↗	Renal Effects of Intrarenal Nesiritide	Terminated	University of Maryland	Phase 4	2005-12-01	The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation leads to adverse consequences even if the direct renal effects are positive. Therefore, this study will look at the effects of direct intrarenal administration of nesiritide on GFR and RPF.
NCT00270829 ↗	Renal Effects of Intrarenal Nesiritide	Terminated	University of Maryland, Baltimore	Phase 4	2005-12-01	The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation leads to adverse consequences even if the direct renal effects are positive. Therefore, this study will look at the effects of direct intrarenal administration of nesiritide on GFR and RPF.
NCT01033630 ↗	Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen	Completed	Chinese University of Hong Kong	Phase 2	2006-01-01	Atherosclerosis (in particular stroke and heart attack) is the most important health issue in modernized society and high blood pressure is an important predisposing factor. Hypertensive subjects with other chronic disease such as diabetes mellitus or impaired renal function are particularly vulnerable to these atherosclerotic complications in spite of standard antihypertensive therapies. Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac symptoms and atherosclerosis-related disorders. The objective of this study is to test Danshen and Gegen as an cardiovascular-protective adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.
NCT01677247 ↗	Bioequivalence Study of 4 mg Glimepiride Tablet	Completed	Dexa Medica Group	N/A	2011-02-01	This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).
NCT01682577 ↗	Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition	Completed	Dexa Medica Group	N/A	2008-09-01	The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).
NCT01729663 ↗	Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients	Unknown status	Agencia Nacional de Promocion Cientifica y Tecnica, Argentina	Phase 2/Phase 3	2009-04-01	Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine , allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar). The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.). Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months. CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then one dose every two months for the first year and them every three months for the second year. Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines, not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used. IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for four weeks and then 5 MU (3t/w) for 23 months. Both treatments will also compare quality of life (QOL) and study a possible correlation in the CSF470 vaccine arm between the induced immune response and clinical outcome
NCT01729663 ↗	Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients	Unknown status	Fundacion Cancer FUCA	Phase 2/Phase 3	2009-04-01	Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine , allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar). The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.). Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months. CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then one dose every two months for the first year and them every three months for the second year. Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines, not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used. IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for four weeks and then 5 MU (3t/w) for 23 months. Both treatments will also compare quality of life (QOL) and study a possible correlation in the CSF470 vaccine arm between the induced immune response and clinical outcome

Clinical Trial Conditions for Germa-medica Mg

Condition Name

Condition Name for Germa-medica Mg
Intervention	Trials
Healthy	7
Small-cell Lung Cancer	2
Diabetes	1
Palliative Care	1

Condition MeSH

Condition MeSH for Germa-medica Mg
Intervention	Trials
Small Cell Lung Carcinoma	2
Lung Neoplasms	2
Calcinosis	1
Hypertension	1

Clinical Trial Locations for Germa-medica Mg

Trials by Country

Trials by Country for Germa-medica Mg
Location	Trials
China	11
Indonesia	8
Colombia	4
Mexico	1
Guatemala	1

Trials by US State

Trials by US State for Germa-medica Mg
Location	Trials
Maryland	1

Clinical Trial Progress for Germa-medica Mg

Clinical Trial Phase

Clinical Trial Phase for Germa-medica Mg
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	3
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Germa-medica Mg
Clinical Trial Phase	Trials
Completed	11
Recruiting	6
Unknown status	4

Clinical Trial Sponsors for Germa-medica Mg

Sponsor Name

Sponsor Name for Germa-medica Mg
Sponsor	Trials
Dexa Medica Group	8
Chinese University of Hong Kong	2
Peking University First Hospital	2

Sponsor Type

Sponsor Type for Germa-medica Mg
Sponsor	Trials
Other	44
Industry	11

Current Landscape and Future Projections for Myasthenia Gravis Treatments: A Comprehensive Update

Introduction to Myasthenia Gravis

Myasthenia gravis (MG) is a chronic autoimmune disorder characterized by muscle weakness and fatigue, resulting from the immune system's attack on the acetylcholine receptors at the neuromuscular junction. The treatment landscape for MG is evolving rapidly, with several promising clinical trials and market projections indicating significant growth.

Clinical Trials Update

Ongoing Clinical Trials

Several clinical trials are currently underway to evaluate new and innovative treatments for MG.

RESET-MG Study

• This Phase 1/2 study by Cabaletta Bio is investigating the safety and efficacy of CABA-201, a chimeric antigen receptor (CAR) T cell therapy, in patients with generalized MG[1].

Descartes-08 CAR-T Cells

• Cartesian Therapeutics is conducting a Phase Ib/IIa study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with generalized MG[1].

SYNAPSE-MG Study

• NMD Pharma A/S and Novartis Pharmaceuticals are conducting a Phase 2 proof-of-concept study to evaluate the safety and efficacy of NMD670 in adult patients with MG. This study involves three dose levels of NMD670 versus placebo[1].

ADAPT SERON Study

• This Phase 3 study by argenx is assessing the efficacy and safety of efgartigimod IV in patients with AChR-Ab seronegative generalized MG[1].

MuSK-CAART Study

• A Phase 1, open-label study by the University of Kansas Health Center is evaluating the safety and dose-finding of autologous muscle-specific tyrosine kinase chimeric autoantibody receptor T cells (MuSK-CAART) in subjects with anti-MuSK-antibody-positive MG[4].

Advanced Pipeline Programs

• Batoclimab (HBM9161): Harbour BioMed’s fully human anti-FCGRT monoclonal antibody is pending approval in China and is expected to launch in Q1 2025. It has shown significant efficacy in reducing MG-ADL scores in Phase 3 trials[3].

• Nipocalimab: Johnson & Johnson’s FCGRT antagonist is in advanced Phase 3 trials and is expected to reach the market in the fourth quarter of 2025[3].

• Inebilizumab: Amgen’s anti-CD19 mAb is also in Phase 3 trials and is anticipated to be available in the fourth quarter of 2025[3].

Market Analysis and Projections

Current Market Size and Growth

The global myasthenia gravis treatment market was valued at USD 2.01 billion in 2022 and is expected to grow at a CAGR of 9.0% from 2023 to 2030. This growth is driven by an increase in pipeline studies for drug development, with the pipeline studies segment anticipated to grow at a CAGR of 41.8% over the forecast period[2].

Segment Analysis

• End Use: The hospital segment holds the largest market share, around 55% in 2022, due to the high demand for advanced equipment and a large patient pool. This segment is expected to grow at a CAGR of 9.0% over the forecast period[2].

• Geographical Distribution: The Middle East and Africa region is expected to grow at the fastest CAGR of 14.9%, driven by the rising prevalence of MG, increasing awareness, and expansion of healthcare infrastructure. The Asia Pacific region is also anticipated to grow significantly due to increased revenue from medications such as immunosuppressants and monoclonal antibodies[2].

Key Market Players

Companies like Alexion Pharmaceuticals and Astellas Pharma dominate the market with strong sales of their flagship products, including Soliris and Prograf. Other key players include argenx, Harbour BioMed, and Amgen, which are advancing with promising pipeline programs[2].

Future Projections

Market Size by 2032

The myasthenia gravis market is projected to grow from $3 billion in 2022 to $6.7 billion by 2032 across the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) at a CAGR of 8.3%[5].

Emerging Therapies

• CAR-T Cell Therapies: These therapies involve genetically modifying T cells to target specific proteins in the autoimmune response, aiming to eliminate autoreactive B cells that produce antibodies against AChRs. This approach is being explored in several ongoing clinical trials[3].

• FCGRT Antagonists and Complement Inhibitors: These mechanisms of action are expected to continue playing a significant role in the treatment landscape, with batoclimab and nipocalimab being key examples[3].

Key Takeaways

• The myasthenia gravis treatment landscape is rapidly evolving with several promising clinical trials.
• CAR-T cell therapies and FCGRT antagonists are among the innovative approaches being investigated.
• The global MG treatment market is expected to grow significantly, driven by pipeline developments and increasing demand for advanced treatments.
• Key market players are investing heavily in research and development, leading to improved treatment options for patients.

FAQs

What are the current clinical trials for myasthenia gravis?

• Several clinical trials are ongoing, including the RESET-MG study for CABA-201, Descartes-08 CAR-T cells, SYNAPSE-MG for NMD670, and ADAPT SERON for efgartigimod IV[1].

Which companies are leading in the myasthenia gravis treatment market?

• Companies like Alexion Pharmaceuticals, Astellas Pharma, argenx, Harbour BioMed, and Amgen are key players in the MG treatment market[2].

What is the projected growth of the myasthenia gravis treatment market?

• The market is expected to grow from $3 billion in 2022 to $6.7 billion by 2032 at a CAGR of 8.3%[5].

What are the emerging therapies for myasthenia gravis?

• Emerging therapies include CAR-T cell therapies, FCGRT antagonists, and complement inhibitors, such as batoclimab and nipocalimab[3].

Where is the fastest growth in the myasthenia gravis treatment market expected?

• The Middle East and Africa region is expected to grow at the fastest CAGR of 14.9% due to rising prevalence, increasing awareness, and expansion of healthcare infrastructure[2].

Sources

1. Myasthenia Gravis Foundation of America: Clinical Trial Opportunities.
2. Grand View Research: Myasthenia Gravis Treatment Market Size Report, 2030.
3. IQVIA: Myasthenia Gravis: An Update on Key Selected Pipeline.
4. Myasthenia Gravis Association: Clinical Trials.
5. Clinical Trials Arena: Myasthenia gravis market to generate sales of $6.7bn by 2032.