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Find Neurology Drugs in Phase I/II Clinical Development in UNITED STATES

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            Lead Product(s): STK-001

            Therapeutic Area: Neurology Product Name: STK-001

            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 October 07, 2020

            Details:

            Following recent interactions with the U.S. FDA related to the partial clinical hold on higher dose levels in the MONARCH study, the FDA will allow the Company to add an additional higher dose level to the single ascending dose portion of the study assessing STK-001.

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            Lead Product(s): STK-001

            Therapeutic Area: Neurology Product Name: STK-001

            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 August 26, 2020

            Details:

            Data published in the journal Science Translational Medicine showed that STK-001 achieved target engagement, pharmacologic activity and efficacy by selectively increasing Scn1a gene and Nav1.1 protein expression.

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            Lead Product(s): PR006

            Therapeutic Area: Neurology Product Name: PR006

            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 July 27, 2020

            Details:

            PR006 is being developed as a potential one-time gene therapy for FTD-GRN, a progressive neurodegenerative disease caused by mutations in the GRN gene that reduce production of progranulin.

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            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.

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            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.

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            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.

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            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.

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            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).

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            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.

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            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.

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