Parkinson’s Disease Pipeline Assessment, FDA Approvals, Clinical Trials, Emerging Drugs, and Therapeutics Assessment 2023 | Major Companies – Biogen, Roche, BioVie Inc, AbbVie, and Others
DelveInsight’s, “Parkinson’s Disease Pipeline Insight 2023” report provides comprehensive insights about 140+ companies and 150+ pipeline drugs in Parkinson’s Disease pipeline landscape. It covers the Parkinson’s Disease pipeline drug profiles, including Parkinson’s Disease clinical trials and nonclinical stage products. It also covers the Parkinson’s Disease therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Recent Developmental Activities in the Parkinson’s Disease Treatment Landscape
- In December 2021, Pharma Two B Ltd. announced that its Phase III double-blind, active-controlled study of P2B001 in early Parkinson’s disease successfully met its primary and key secondary endpoints in the Phase III study, P2B001 was superior to each of its individual components as measured by the change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale (UPDRS Part II and III; primary endpoint). P2B001 was superior to the pramipexole component by 2.66 points (p=0.0018) and superior to the rasagiline component by 3.30 points (p=0.0001).
- In December 2021, UCB announced that it has entered into a global co-development and co-commercialization agreement with Novartis covering UCB0599, a potential first in class, small molecule, alpha-synuclein misfolding inhibitor currently in Phase 2 clinical development, and upon completion of the ongoing Phase 1 program, an opt-in to co-develop UCB7853, an anti-alpha-synuclein antibody, both in Parkinson’s Disease (PD).
- Gain Therapeutics presented preclinical data during a poster session at the Society for Neuroscience Annual Meeting, being held virtually from November 8 – 11, 2021. The findings demonstrate that the Company’s lead compound GT-02287, which specifically binds to lysosomal enzyme glucocerebrosidase (GCase), reduces alpha-synuclein pathology and neuroinflammation in a dose-dependent manner, as well as improves behavioral deficits in an animal model of Parkinson’s Disease.
- In November 2021, Sio Gene Therapies Inc. provided a manufacturing and regulatory update for AXO-Lenti-PD, its clinical-stage gene therapy for Parkinson’s disease. Three GMP batches successfully completed fill and finish, achieving target titers using the updated suspension-based process
- In October 2021, AbbVie announced that continuous 24 hours/day subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) was statistically superior to oral levodopa/carbidopa in reducing motor fluctuations in patients with advanced Parkinson’s disease (PD) in a Phase 3, randomized, double-blind, double-dummy, active-controlled study. The study met its primary endpoint of increase from baseline in “On” time (hours) without troublesome dyskinesia (involuntary movements) after 12 weeks based on the Parkinson’s Disease Diary (PD Diary). These results will be a key component of global regulatory submissions.
- In October 2021, Inhibikase Therapeutics announced the dosing of the first Parkinson’s patient in its Phase 1b clinical trial of IkT-148009, an Abelson Tyrosine Kinase, or c-Abl, an inhibitor for the treatment of Parkinson’s disease.
- In May 2021, Denali Therapeutics announced final results from Phase 1 and Phase 1b studies of its small molecule LRRK2 inhibitor, BIIB122/DNL151, which is being developed in collaboration with Biogen as a potential treatment of Parkinson’s disease.
- In April 2021, Cerevel Therapeutics announced an up to $125 million non-dilutive financing transaction with NovaQuest and Bain Capital to fund the full Phase 3 development program for tavapadon in Parkinson’s disease, also known as the TEMPO trials.
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Parkinson’s Disease Overview
Parkinson’s disease is a progressive disorder that is caused by degeneration of nerve cells in the part of the brain called the substantia nigra, which controls movement. These nerve cells die or become impaired, losing the ability to produce an important chemical called dopamine. Studies have shown that symptoms of Parkinson’s develop in patients with an 80 percent or greater loss of dopamine-producing cells in the substantia nigra.
Key Takeaways from the Parkinson’s Disease Pipeline Report
- DelveInsight’s Parkinson’s Disease pipeline report depicts a robust space with 140+ active players working to develop 150+ pipeline therapies for Parkinson’s Disease treatment.
- The leading Parkinson’s Disease Companies include Cerevel Therapeutics, Abbvie, Pharma Two B, Roche, Kissei Pharmaceutical, Peptron, Inc., Lundbeck A/S, AstraZeneca, Nobilis Therapeutics, Treefrog Therapeutics, Cantabio Pharmaceuticals, Anavex Life Sciences, Ipsen, Prevail Therapeutics, AFFiRiS, Sio Gene Therapies, UCB Pharma, Brain Neurotherapy Bio, Inc., Neuraly, Inc., NeuroDerm, BlueRock Therapeutics, Sun Pharma Advanced Research Company, Xoc Pharmaceuticals, Hong Kong WD Pharmaceutical, 1ST Biotherapeutics, Inc., Biogen, Denali Therapeutics, Inhibikase Therapeutics,Cerevance, Aspen Neuroscience,Prilenia Therapeutics,Cortexyme Inc.,Gain Therapeutics, Clexio Biosciences, Orpheris, Inc., Alkahest, Inc, and others.
- Promising Parkinson’s Disease Pipeline Therapies in various stages of development include Rotigotine, extended-release microspheres, LY03003, LY3884961, Methylprednisolone, Sirolimus, VY-AADC02, ERE-120: AAV2-NTN, Liatermin, MEDI1341, and others.
- The Parkinson’s Disease Companies and academics that are working to assess challenges and seek opportunities that could influence Parkinson’s disease R&D. The Parkinson’s Disease pipeline therapies under development are focused on novel approaches to treat/improve the disease condition.
For further information, refer to the detailed Parkinson’s Disease Drugs Launch, Parkinson’s Disease Developmental Activities, and Parkinson’s Disease News, click here for Parkinson’s Disease Ongoing Clinical Trial Analysis
Parkinson’s Disease Emerging Drugs Profile
- Tavapadon: Cerevel Therapeutics
Tavapadon was designed to improve motor symptoms in Parkinson’s disease by selectively targeting and binding to dopamine D1/D5 receptor subtypes. Tavapadon differentially activates the direct motor pathway, potentially driving motor benefit while minimizing side effects typical of drugs that non-selectively stimulate dopamine, such as daytime sedation, or somnolence, compromised impulse control and risk of psychotic symptoms including hallucinations. Tavapadon is also designed to activate the D1/D5 receptor subtypes at levels that maximize motor benefit while reducing the prolonged receptor overexcitation and desensitization caused by full agonists, which can lead to dyskinesias and exacerbation of “off” time. Currently, it is in Phase III stage of clinical trial evaluation to treat Parkinson disease.
- IkT-148009: Inhibikase Therapeutics
Inhibikase Therapeutics’ lead product candidate, IkT-148009, is a potent, selective small-molecule medication designed and engineered as chronically administered, once-daily oral medication targeting the underlying biological mechanism resulting in Parkinson’s disease, with the goal of halting disease progression and reversing functional loss. IkT-148009 is designed to block the activation of Abl kinase, a clinically validated drug target, to halt and reverse the loss of dopamine-secreting neurons in the brain and GI tract by restoring neuroprotective mechanisms.
- NLY01: Neuraly
NLY01 is a proprietary long-acting analogue of exendin-4, a glucagon-like peptide-1 receptor (GLP-1R) agonist. NLY01 penetrates the blood-brain barrier (BBB) in animal models and its receptor (GLP-1R) is highly expressed on glial cells. NLY01 is being developed as a disease-modifying agent for neurodegenerative disorders including Parkinson’s and Alzheimer’s disease. In clinically relevant animal models, NLY01 was found to prevent neuronal cell death by inhibition of microglial activation and formation of A1 neurotoxic astroglial cells. Treatment with NLY01 slowed disease progression, improved motor and cognitive functions and extended the lifespan in mice with Parkinson’s disease.
- PT320: Peptron
PT320 is a sustained-release Exenatide (GLP1 agonist) for biweekly injection (Q2W). Due to its short half-life of 2.4 hours in the plasma of Exenatide, Peptron has developed a long-acting SR-Exenatide (PT320), resulting in sustained elevations of Exenatide for 20 days. With the result of preclinical and Phase I study of PT320, Peptron is testing the efficacy of PT320 of Parkinson’s disease in the on-going Phase II trial.
Parkinsons Disease Therapeutics Assessment
There are approx. 140+ key companies which are developing the therapies for Parkinson’s disease. The companies which have their Parkinson’s disease drug candidates in the most advanced stage, i.e. phase III include, Cerevel Therapeutics.
Find out more about the Parkinson’s disease Pipeline Segmentation, Therapeutics Assessment, and Parkinson’s disease Emerging Drugs @ Parkinson’s Disease Treatment Landscape
Scope of the Parkinson’s Disease Pipeline Report
- Coverage- Global
- Parkinson’s Disease Companies- Cerevel Therapeutics, Abbvie, Pharma Two B, Roche, Kissei Pharmaceutical, Peptron, Inc., Lundbeck A/S, AstraZeneca, Nobilis Therapeutics, Treefrog Therapeutics, Cantabio Pharmaceuticals, Anavex Life Sciences, Ipsen, Prevail Therapeutics, AFFiRiS, Sio Gene Therapies, UCB Pharma, Brain Neurotherapy Bio, Inc., Neuraly, Inc., NeuroDerm, BlueRock Therapeutics, Sun Pharma Advanced Research Company, Xoc Pharmaceuticals, Hong Kong WD Pharmaceutical, 1ST Biotherapeutics, Inc., Biogen, Denali Therapeutics, Inhibikase Therapeutics, Cerevance, Aspen Neuroscience, Prilenia Therapeutics, Cortexyme Inc., Gain Therapeutics, Clexio Biosciences, Orpheris, Inc., Alkahest, Inc., and many others.
- Parkinson’s Disease Pipeline Therapies- Rotigotine, extended-release microspheres, LY03003, LY3884961, Methylprednisolone, Sirolimus, VY-AADC02, ERE-120: AAV2-NTN, Liatermin, MEDI1341, and others.
- Parkinson’s Disease Segmentation: Molecule Type, Mechanism of Action, Route of Administration, Product Type
Dive deep into rich insights for drugs for Parkinson’s Disease Pipeline Companies and Therapies, click here @ Parkinson’s Disease Unmet Needs and Analyst Views
Table of Content
- Introduction
- Parkinson’s Disease Executive Summary
- Parkinson’s Disease: Overview
- Parkinson’s Disease Pipeline Therapeutics
- Parkinson’s Disease Therapeutic Assessment
- Parkinson’s Disease – DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Tavapadon: Cerevel Therapeutics
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Prasinezumab : Roche
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- MEDI1341: AstraZeneca
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Neural microtissues: Treefrog Therapeutics
- Drug profiles in the detailed report…..
- Inactive Products
- Parkinson’s Disease Key Companies
- Parkinson’s Disease Key Products
- Parkinson’s Disease- Unmet Needs
- Parkinson’s Disease- Market Drivers and Barriers
- Parkinson’s Disease- Future Perspectives and Conclusion
- Parkinson’s Disease Analyst Views
- Parkinson’s Disease Key Companies
- Appendix
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