Neurology | Phase I/ Phase II Developments

Axovant Gene Therapies

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Four Patients Given Higher AXO-Lenti-PD Dose in Gene Therapy Trial

Lead Product(s): AXO-Lenti-PD

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2020

Details:

A Phase 1/2 clinical trial testing AXO-Lenti-PD (OXB102), Axovant‘s experimental gene therapy for Parkinson’s disease, has completed dosing of all four adults in a second group in its dose-escalation part of the study.

Aim ImmunoTech

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AIM ImmunoTech files provisional patent application for Ampligen as treatment for COVID-19 induced fatigue

Lead Product(s): Rintatolimod,Interferon Alfa-2B

Therapeutic Area: Neurology Product Name: Ampligen

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

Company has filed a provisional patent application for, among other discoveries, the use of its experimental drug Ampligen® as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue, which shows similarities to ME/CFS.

Heron Therapeutics

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Heron Therapeutics Begins Phase 1b/2 Study of HTX-034 to Treat Postoperative Pain

Lead Product(s): Bupivacaine,Meloxicam

Therapeutic Area: Neurology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2020

Details:

The study initiation follows clearance from the US Food and Drug Administration (FDA) of Heron's Investigational New Drug (IND) application for HTX-034 for the treatment of postoperative pain.

Alpha Cognition

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CANADA Canada

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Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy

Lead Product(s): Alpha-1062

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2020

Details:

U.S. FDA agreed upon a clinical and regulatory pathway for the approval of Alpha-1062 and has suggested that a single pivotal trial, scheduled for mid-2021.

Harbour BioMed

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Harbour BioMed Announces First Patient Dosed in Phase 1b/2a Study of Anti-FcRn Batoclimab to Treat Neuromyelitis Optica Spectrum Disorder

Lead Product(s): Batoclimab

Therapeutic Area: Neurology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2020

Details:

The study aims to assess the safety, tolerability, pharmacodynamics, and efficacy of batoclimab in patients with NMOSD in China. It is the first anti-FcRn PoC study for the treatment of NMOSD.

resTORbio

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resTORbio Announces Delay of its Ongoing Phase 1b/2a trial of RTB101

Lead Product(s): RTB101

Therapeutic Area: Neurology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 03, 2020

Details:

Company will postpone enrollment in the fifth cohort of its ongoing Phase 1b/2a trial of RTB101 alone or in combination with sirolimus, in Parkinson’s disease (PD).

Axial Biotherapeutics, Inc

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Axial Biotherapeutics Announces Positive Topline Results from Phase 1b/2a Clinical Trial of AB-2004 for Autism Spectrum Disorder

Lead Product(s): AB-2004

Therapeutic Area: Neurology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 02, 2020

Details:

The study met the primary endpoint of safety, tolerability and adherence with no drug-related adverse events (AE) reported.

Prevail Therapeutics

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Prevail Therapeutics to Present at AAT-AD/PD Focus Meeting 2020: Advances in Alzheimer’s and Parkinson’s Therapies

Lead Product(s): PR001

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 31, 2020

Details:

The presentation will highlight preclinical data related to PR001 for PD-GBA and the design of PROPEL, Phase 1/2 clinical trial to evaluate the safety and efficacy of PR001 in patients with PD-GBA.

Regenacy Pharmaceuticals

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Regenacy Pharmaceuticals Raises $30 Million in Series A Financing

Lead Product(s): Ricolinostat

Therapeutic Area: Neurology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Cobro Ventures

Deal Size: $30.0 million Upfront Cash: Undisclosed

Deal Type: Series A Financing March 25, 2020

Details:

Regenacy plans to use the proceeds to initiate a Phase 2 proof-of-concept trial for ricolinostat, an oral, selective histone deacetylase 6 (HDAC6) inhibitor, in diabetic peripheral neuropathy.

Prevail Therapeutics

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Prevail Therapeutics Provides Clinical Advancement Update on PR001 for the Treatment of Parkinson’s Disease with GBA1 mutations

Lead Product(s): PR001

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 03, 2020

Details:

Enrollment in the PR001 Phase 1/2 PROPEL clinical trial is progressing, patient dosing continues, and the Company is on track to report interim data in the second half of 2020.

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Phase I/ Phase II

Product Type

Companies

Axovant Gene Therapies

Four Patients Given Higher AXO-Lenti-PD Dose in Gene Therapy Trial

Aim ImmunoTech

AIM ImmunoTech files provisional patent application for Ampligen as treatment for COVID-19 induced fatigue

Heron Therapeutics

Heron Therapeutics Begins Phase 1b/2 Study of HTX-034 to Treat Postoperative Pain

Alpha Cognition

Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy

Harbour BioMed

Harbour BioMed Announces First Patient Dosed in Phase 1b/2a Study of Anti-FcRn Batoclimab to Treat Neuromyelitis Optica Spectrum Disorder

resTORbio

resTORbio Announces Delay of its Ongoing Phase 1b/2a trial of RTB101

Axial Biotherapeutics, Inc

Axial Biotherapeutics Announces Positive Topline Results from Phase 1b/2a Clinical Trial of AB-2004 for Autism Spectrum Disorder

Prevail Therapeutics

Prevail Therapeutics to Present at AAT-AD/PD Focus Meeting 2020: Advances in Alzheimer’s and Parkinson’s Therapies

Regenacy Pharmaceuticals

Regenacy Pharmaceuticals Raises $30 Million in Series A Financing

Prevail Therapeutics

Prevail Therapeutics Provides Clinical Advancement Update on PR001 for the Treatment of Parkinson’s Disease with GBA1 mutations