Neurology | Phase II/ Phase III Developments | UNITED STATES

Axsome Therapeutics

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ASCO 2020

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Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer’s Disease Agitation

Lead Product(s): Dextromethorphan,Bupropion

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2020

Details:

AXS-05 met the primary endpoint in the ADVANCE-1 Phase 2/3 trial and rapidly, substantially, and significantly improved agitation in patients with Alzheimer’s disease as compared to placebo.

Anavex Life Sciences

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Anavex Life Sciences Announces Publication of Clinical Data for ANAVEX®2-73 (blarcamesine) in Alzheimer’s Disease

Lead Product(s): Blarcamesine

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2020

Details:

Clinically meaningful biomarkers identified in ANAVEX®2-73 (Blarcamesine) studies demonstrate a significant impact on clinical outcomes at one year (57 weeks) and beyond three years (148 weeks)

Biohaven Pharmaceuticals

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Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migrain

Lead Product(s): Vazegepant

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 23, 2020

Details:

The Company addressed all issues raised by the FDA and will advance the 10 mg dose of intranasal vazegepant into a double-blind, placebo-controlled Phase 3 clinical trial.

Axsome Therapeutics

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Axsome Accelerates Completion Of Advance-1 Phase 2/3 Trial Of Axs-05 In Alzheimer's Disease Agitation

Lead Product(s): Dextromethorphan,Bupropion

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 20, 2020

Details:

Company is accelerating the completion of the ADVANCE-1 Ph 2/3 trial of AXS-05 in Alzheimer’s disease agitation to ensure the safety of this patient population during the COVID-19 pandemic.

Cortexyme

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Cortexyme Announces Gain Trial in Alzheimer’s Disease Has Reached Enrollment Milestone of 300 Patients

Lead Product(s): COR388

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2020

Details:

Sub-study shows greater than 90% of enrolled patients have moderate to severe periodontal disease, indicating relevance to mechanism of action against P. gingivalis.

Cortexyme

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Cortexyme Provides Regulatory Update For COR388 Development Program In Alzheimer’S Disease

Lead Product(s): COR388

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 13, 2020

Details:

Interim analysis in phase 2/3 gain trial expected to occur in q4 2020.

Eli Lilly

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Lilly Announces Topline Results for Solanezumab from DIAN-TU Study

Lead Product(s): Solanezumab

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 10, 2020

Details:

Study showed that solanezumab did not meet the primary endpoint.

Genentech

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Genentech Provides Topline Results From Gantenerumab Study

Lead Product(s): Gantenerumab

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 07, 2020

Details:

Primary endpoint was not met in a study sponsored by Washington University; additional analyses are ongoing to understand the totality of the data

PTC Therapeutics

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SUNFISH Pivotal Results for Risdiplam Demonstrate Meaningful Benefit

Lead Product(s): Risdiplam

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 06, 2020

Details:

Risdiplam is the first SMA treatment to have positive placebo-controlled data in pivotal studies across a real world population of infants, children, teenagers and adults

Cortexyme

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Cortexyme Announces Publication of New Data Further Demonstrating the Therapeutic Potential of COR388, the Company’s Lead Investigational ...

Lead Product(s): COR388

Therapeutic Area: Neurology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 30, 2020

Details:

Data in aged dogs shows oral dosing of COR388 results in target engagement, reduction of bacterial load and beneficial effects on downstream pathology.

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Axsome Therapeutics

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer’s Disease Agitation

Anavex Life Sciences

Anavex Life Sciences Announces Publication of Clinical Data for ANAVEX®2-73 (blarcamesine) in Alzheimer’s Disease

Biohaven Pharmaceuticals

Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migrain

Axsome Therapeutics

Axsome Accelerates Completion Of Advance-1 Phase 2/3 Trial Of Axs-05 In Alzheimer's Disease Agitation

Cortexyme

Cortexyme Announces Gain Trial in Alzheimer’s Disease Has Reached Enrollment Milestone of 300 Patients

Cortexyme

Cortexyme Provides Regulatory Update For COR388 Development Program In Alzheimer’S Disease

Eli Lilly

Lilly Announces Topline Results for Solanezumab from DIAN-TU Study

Genentech

Genentech Provides Topline Results From Gantenerumab Study

PTC Therapeutics

SUNFISH Pivotal Results for Risdiplam Demonstrate Meaningful Benefit

Cortexyme

Cortexyme Announces Publication of New Data Further Demonstrating the Therapeutic Potential of COR388, the Company’s Lead Investigational ...