DelveInsight’s ‘Amyotrophic Lateral Sclerosis Pipeline Insight 2023‘ report provides comprehensive global coverage of available, marketed, and pipeline Amyotrophic Lateral Sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Amyotrophic Lateral Sclerosis pipeline domain.
For Amyotrophic Lateral Sclerosis emerging drugs, the Amyotrophic Lateral Sclerosis pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.
Key Takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report
- DelveInsight’s Amyotrophic Lateral Sclerosis Pipeline analysis depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for Amyotrophic Lateral Sclerosis treatment.
- The leading Amyotrophic Lateral Sclerosis companies include Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others are evaluating their lead assets to improve the Amyotrophic Lateral Sclerosis treatment landscape.
- Key Amyotrophic Lateral Sclerosis pipeline therapies in various stages of development include BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others.
- In April 2023, AB Science S.A. provided an update on the timeline for the evaluation of its applications for conditional approval of masitinib in the treatment of amyotrophic lateral sclerosis by the European Medicines Agency (EMA) and Health Canada’s Committee for Medicinal Products for Human Use (CHMP) (ALS).
- In April 2023, Seelos Therapeutics, Inc. announced that the first patient in an Expanded Access Program (EAP) for patients with ALS who do not qualify for existing clinical trials had been dosed and that an NINDS grant under the ACT for ALS will fully fund the EAP.
- In March 2023, BrainStorm Cell Therapeutics Inc. announced that the FDA would hold an Advisory Committee Meeting (‘ADCOM’) to discuss the company’s Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS).
- In March 2023, Coya Therapeutics, Inc. reported 48-week clinical data from its proof-of-concept open-label study in four ALS patients, indicating that treatment with COYA 302 appeared to slow disease progression.
- In February 2023, NeuroSense Therapeutics Ltd. and QuantalX Neuroscience Ltd, the developer of Delphi-MD, a clinically objective neurodiagnostic medical device, announced a collaboration to improve early diagnosis and treatment of neurodegenerative diseases. In addition, the companies agreed that QuantalX’s Delphi-MD would be used for early diagnosis and ongoing monitoring of trial participants in NeuroSense’s planned future pivotal Phase III efficacy trial of PrimeC in people living with amyotrophic lateral sclerosis (ALS), pending the successful conclusion of its ALS Phase IIb trial.
- In February 2023, Amylyx Pharmaceuticals, Inc. announced the completion of enrollment in PHOENIX, a global, 48-week, randomized, placebo-controlled Phase III clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS). Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS.
- In February 2023, UMass Chan Medical School signed a three-year sponsored research agreement with NeuShen Therapeutics Inc. to investigate a gene therapy treatment for amyotrophic lateral sclerosis, a rare neurological disease. Based in Shanghai and Boston, NeuShen is focused on developing innovative treatments for central nervous system disorders using adeno-associated virus-based gene therapy and small molecule delivery.
- In January 2023, Inflamed Pharma, part of the incubator and accelerator company Xlife Sciences, partnered with researchers at the University Medical Center Gottingen in Germany to develop its investigational therapy ProcCluster for the treatment of amyotrophic lateral sclerosis (ALS). The collaboration, led by Jan C. Koch, MD, a principal investigator at the university’s Department of Neurology, will be focused particularly on investigating ProcCluster in cellular models of ALS.
- In January 2023, Amylyx Pharmaceuticals and Neopharm signed a license and distribution agreement to commercialize AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS). Neopharm will commercialize the oral, fixed-dose medication in Israel, West Bank, Gaza, and the Palestinian Authority, subject to regulatory review and clearance. According to the agreement, Amylyx will grant exclusive rights to Neopharm for commercializing the therapy in the covered territory.
- In January 2023, uniQure N.V. and Apic Bio announced that they have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS. Under the agreement, uniQure acquires global rights for developing and commercializing APB-102, adding to its pipeline of gene therapies to treat neurological disorders.
Request a sample and discover the recent breakthroughs happening in the Amyotrophic Lateral Sclerosis pipeline landscape @ Amyotrophic Lateral Sclerosis Pipeline Outlook
Amyotrophic Lateral Sclerosis Overview
Amyotrophic Lateral Sclerosis (ALS) is a rare neurological disease that affects the nerve cells that control voluntary muscle movement (neurons) (those muscles we choose to move). Voluntary muscles control movements like chewing, walking, and talking. Because the disease is progressive, the symptoms worsen over time. ALS currently has no cure or effective treatment to slow or reverse disease progression. Early ALS symptoms include muscle weakness or stiffness. As all voluntary muscles are affected, people gradually lose strength and the ability to speak, eat, move, and even breathe. Most people with ALS die from respiratory failure within 3 to 5 years of the onset of symptoms. However, 10% of people with ALS live for ten years or longer. There is no single test that can pinpoint the cause of ALS. To make the ALS diagnosis, a detailed history of the symptoms observed by a physician during physical examination, as well as a review of the individual’s full medical history and a series of tests to rule out other diseases, are used.
Find out more about Amyotrophic Lateral Sclerosis medication @ New Drug for Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis Treatment Analysis: Drug Profile
Tofersen: Biogen
Tofersen is an antisense drug being studied for its potential use in the treatment of SOD1-ALS. Tofersen binds to SOD1 mRNA, allowing it to be degraded by RNase-H to reduce SOD1 protein synthesis. Tofersen is also being investigated in the Phase 3 ATLAS study, which aims to assess Tofersen’s ability to delay clinical onset when initiated in presymptomatic individuals with a SOD1 genetic mutation and biomarker evidence of disease activity. Under a collaborative development and license agreement, Biogen obtained tofersen from Ionis Pharmaceuticals, Inc.
RNS60: Revalesio Corporation
RNS60 is being developed to treat neurological diseases by providing disease modifying and potentially restorative treatments. It increases mitochondrial biogenesis and function, decreasing inflammation by activating intracellular signaling pathways. RNS60 protects neurons and oligodendrocytes while also modulating immune cell activity to restore homeostasis. The US Food and Drug Administration has granted RNS60 Orphan Drug and Fast Track designations for ALS.
Key Amyotrophic Lateral Sclerosis Therapies and Companies
- BIIB067: Biogen
- Masitinib: AB Sciences
- Engensis: Helixmith
- RNS60: Revalesio Corporation
- EPI-589: PTC Therapeutics
- AT-1501: Eledon Pharmaceuticals
- ANX005: Annexon
- Pegcetacoplan: Apellis Pharmaceuticals
- PrimeC: NeuroSense Therapeutics
Learn more about the novel and emerging Amyotrophic Lateral Sclerosis pipeline therapies @ Amyotrophic Lateral Sclerosis Clinical Trials
Amyotrophic Lateral Sclerosis Therapeutics Assessment
- By Product Type
- Monotherapy
- Combination Therapy
- By Stage
- Discovery
- Pre-Clinical
- Phase I
- Phase II
- Phase III
- Pre-registration
- By Route of Administration
-
- Oral
- Parenteral
- Intravenous
- Subcutaneous
- Topical
- By Molecule Type
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
- Gene therapy
Scope of the Amyotrophic Lateral Sclerosis Pipeline Report
- Coverage: Global
- Key Amyotrophic Lateral Sclerosis Companies: Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others.
- Key Amyotrophic Lateral Sclerosis Pipeline Therapies: BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others.
Dive deep into rich insights for drugs used for Amyotrophic Lateral Sclerosis treatment; visit @ Amyotrophic Lateral Sclerosis Drugs
Table of Contents
| 1. | Introduction |
| 2. | Executive Summary |
| 3. | Amyotrophic Lateral Sclerosis Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Amyotrophic Lateral Sclerosis Pipeline Therapeutics |
| 6. | Amyotrophic Lateral Sclerosis Pipeline: Late Stage Products (Phase III) |
| 7. | Amyotrophic Lateral Sclerosis Pipeline: Late Stage Products (Phase III) |
| 8. | Amyotrophic Lateral Sclerosis Pipeline: Mid Stage Products (Phase II) |
| 9. | Amyotrophic Lateral Sclerosis Pipeline: Early Stage Products (Phase I) |
| 10. | Therapeutic Assessment |
| 11. | Inactive Products |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the Amyotrophic Lateral Sclerosis therapy in the pipeline, reach out @ Amyotrophic Lateral Sclerosis Medication
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