Neurology | IND Enabling Drugs | Pipeline Prospector

AEON Biopharma

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AEON Biopharma Announces FDA Acceptance of IND for ABP-450 as a Treatment for Cervical Dystonia; Secures $25 Million Investment

Lead Product(s): PrabotulinumtoxinA

Therapeutic Area: Neurology Product Name: ABP-450

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Daewoong Pharmaceutical

Deal Size: $25.0 million Upfront Cash: Undisclosed

Deal Type: Investment September 03, 2020

Details:

The milestone is expected to provide funding AEON's clinical programs into 2021. The U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ABP-450 to treat cervical dystonia.

Polyneuron Pharmaceuticals

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Switzerland

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Polyneuron’s PN-1007 Receives U.S. FDA Orphan Drug Designation in Anti-MAG Neuropathy

Lead Product(s): PN-1007

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2020

Details:

In a dose titration study in mice, intravenous administration of PN-1007 was able to efficiently remove all anti-MAG IgM antibodies, strongly supporting the anticipated effective dose range for the upcoming phase I/IIa study in patients.

Retrotope

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US FDA Allows Trial to Proceed for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

Lead Product(s): Linoleic Acid

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2020

Details:

Retrotope filed this IND for a PSP Phase 2/3 trial after 3 patients treated with RT001 in PSP Expanded Access protocols showed encouraging results after more than a year on drug.

Neuraptive Therapeutics

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Neuraptive Therapeutics Announces FDA Release of IND Order for Ntx-001, A New Approach For Treating Patients With Peripheral Nerve Injuries

Lead Product(s): NTX-001

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2020

Details:

Neuraptive will conduct a Phase 2 study evaluating the safety and efficacy of NTX-001 vs standard of care in patients with acute single transected peripheral nerve injuries of the upper extremities.

Green Valley Pharmaceuticals

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CHINA China

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Green Valley to Start US Trials of Algae-Based Alzheimer’s Drug

Lead Product(s): Sodium oligomannate

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling 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:

Green Valley Pharma’s scientists have suggested that GV-971 may work by altering the balance of microorganisms in the GI tract that contribute to inflammation in the central nervous system.

ReAlta Life Sciences

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United Kingdom

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ReAlta Life Sciences Closes $14 Million Series A2 Financing to Support Transition into a Clinical Organization

Lead Product(s): RLS-0071

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Children’s Research Holdings

Deal Size: $14.0 million Upfront Cash: Undisclosed

Deal Type: Series A Financing April 21, 2020

Details:

Proceeds will fund advancement of programs addressing acute lung injury due to COVID-19 and severe birth asphyxia (HIE).

Polaryx Therapeutics

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Polaryx Therapeutics Receives IND Approval From the FDA to Study PLX-200

Lead Product(s): PLX-200

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 08, 2020

Details:

Company has received an IND approval from the U.S.FDA to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients.

ProMIS Neurosciences

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ProMIS Neurosciences to Present Data and Moderate Session at AAIC 2020

Lead Product(s): PMN310

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2020

Details:

Both posters highlight data for antibodies that are highly selective for toxic vs. physiologically important forms of proteins implicated in AD and a variety of neurodegenerative diseases.

Aspen Neuroscience

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Aspen Neuroscience Announces $70 Million Series A Financing to Advance First Autologous Neuron Replacement Therapy

Lead Product(s): ANPD001

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: OrbiMed

Deal Size: $70.0 million Upfront Cash: Undisclosed

Deal Type: Series A Financing April 01, 2020

Details:

The funding will support the completion of all remaining IND-enabling studies and FDA submission of the IND relating to Aspen's lead product (ANPD001).

AgeX Therapeutics

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ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared IND for IMS001

Lead Product(s): IMS001

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 20, 2020

Details:

ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.

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Find FDA Investigational New Drug (IND) Submissions for Neurology

IND Enabling

Product Type

Companies

AEON Biopharma

AEON Biopharma Announces FDA Acceptance of IND for ABP-450 as a Treatment for Cervical Dystonia; Secures $25 Million Investment

Polyneuron Pharmaceuticals

Polyneuron’s PN-1007 Receives U.S. FDA Orphan Drug Designation in Anti-MAG Neuropathy

Retrotope

US FDA Allows Trial to Proceed for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

Neuraptive Therapeutics

Neuraptive Therapeutics Announces FDA Release of IND Order for Ntx-001, A New Approach For Treating Patients With Peripheral Nerve Injuries

Green Valley Pharmaceuticals

Green Valley to Start US Trials of Algae-Based Alzheimer’s Drug

ReAlta Life Sciences

ReAlta Life Sciences Closes $14 Million Series A2 Financing to Support Transition into a Clinical Organization

Polaryx Therapeutics

Polaryx Therapeutics Receives IND Approval From the FDA to Study PLX-200

ProMIS Neurosciences

ProMIS Neurosciences to Present Data and Moderate Session at AAIC 2020

Aspen Neuroscience

Aspen Neuroscience Announces $70 Million Series A Financing to Advance First Autologous Neuron Replacement Therapy

AgeX Therapeutics

ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared IND for IMS001