Neurology | Phase I/ Phase II Developments | UNITED STATES

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

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.

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

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

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

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

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

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

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

BioXcel Therapeutics

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BioXcel Therapeutics Announces Proposed Public Offering

Lead Product(s): Dexmedetomidine

Therapeutic Area: Neurology

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

Partner/Sponsor/Collaborator: BofA Securities

Deal Size: $64.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 19, 2020

Details:

The Company intends to use the net proceeds of this offering to advance the development of product candidates, including the funding of clinical trials for BXCL501.

resTORbio

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resTORbio Announces Interim Results for Phase 1b/2a Trial of RTB101 in Patients with Parkinson’s Disease

Lead Product(s): RTB101

Therapeutic Area: Neurology

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 February 19, 2020

Details:

Interim data from three cohorts in the Phase 1b/2a study demonstrate that RTB101 is well tolerated, effective in preclinical models to inhibit the activity of TORC1 and induce autophagy.

Alexion Pharmaceuticals

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Alexion Announces Planned Initiation of Pivotal Phase 3 Study of ULTOMIRIS® (ravulizumab) in ALS

Lead Product(s): Ravulizumab

Therapeutic Area: Neurology

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 January 14, 2020

Details:

A 50-week global study to enroll approximately 350 patients across broad ALS population.

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Heron Therapeutics

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

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

BioXcel Therapeutics

BioXcel Therapeutics Announces Proposed Public Offering

resTORbio

resTORbio Announces Interim Results for Phase 1b/2a Trial of RTB101 in Patients with Parkinson’s Disease

Alexion Pharmaceuticals

Alexion Announces Planned Initiation of Pivotal Phase 3 Study of ULTOMIRIS® (ravulizumab) in ALS