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Details:
COR 388 (atuzaginstat) is an orally administered bacterial protease inhibitor, being developed for treatment of Alzheimer's Disease, targets the toxic proteases, or gingipains, produced by P. gingivalis, which have been discovered in greater than 90% of AD patients.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
By engaging a novel upstream target, COR388 (atuzaginstat) demonstrated numerical trends to benefit in tau biomarkers, which is consistent with the observed slowing of Alzheimer’s disease progression.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
Gain trial will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 (atuzaginstat) oral capsules in subjects with probable AD dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2022
Details:
First-in-class lysine gingipain inhibitor, atuzaginstat, has the potential to reduce the malignant progression of oral potentially malignant disorders, In vitro study results demonstrate that PD-L1 is induced by P. gingivalis and can be blocked by atuzaginstat.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
COR388 (atuzaginstat), a novel gingipain inhibitor decreases fragmentation of APOE in the central nervous system of Alzheimer’s disease patients in a Phase 2/3 GAIN Trial for P. gingivalis infection.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2022
Details:
The study data showed that treatment with atuzaginstat slowed decline compared to placebo on the majority of clinical endpoints in prespecified populations that were selected based on P. gingivalis infection markers.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2021
Details:
Atuzaginstat (COR388), an investigational orally administered small-molecule that targets gingipain proteases from the bacterium Porphyromonas gingivalis (P. gingivalis) to treat moderate patients with Alzheimer’s disease.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2021
Details:
Cortexyme shares updated and new baseline biomarker data from the full set of patients in the study that supports that this is an appropriate population for testing atuzaginstat for Alzheimer’s disease.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2021
Details:
Two poster presentations covering an update from its pivotal Phase 2/3 GAIN Trial of atuzaginstat, in addition to new data demonstrating the upstream role that P. gingivalis plays in key pathology of Alzheimer’s disease.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
Multiple studies were used to determine an effective exposure and dose regimen. A previously peer-reviewed publication established efficacy of atuzaginstat in reducing oral infection and periodontal disease in a naturally occurring aged dog model.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
Details:
The U.S. Food and Drug Administration (FDA) stating that a partial clinical hold has been placed on atuzaginstat (COR388) impacting the open-label extension (OLE) phase of the company’s ongoing Phase 2/3 study, the GAIN Trial.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2021
Details:
Independent Data Monitoring Committee (DMC) conducted a pre-planned interim analysis and recommended Cortexyme continue the Phase 2/3 GAIN Trial of atuzaginstat (COR388) as planned to the 1-year endpoint.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 04, 2020
Details:
Data demonstrate that patients enrolled in the GAIN Trial have baseline biomarkers consistent with Alzheimer’s disease and potential responders to atuzaginstat.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
GAIN Trial for Alzheimer’s disease (AD) has exceeded its enrollment target of 570 patients. GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of atuzaginstat (COR388), Cortexyme’s lead investigational medicine, in patients with mild to moderate AD.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
Cortexyme's ‘826 patent provides additional composition of matter protection for atuzaginstat and gingipain inhibitors, with additional claims pending in related applications.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of atuzaginstat (COR388), Cortexyme’s lead investigational medicine, in patients with mild to moderate AD.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 14, 2020
Details:
The accepted abstracts further document the role that P. gingivalis plays as a driver of Alzheimer’s-like neuropathology, and highlight the potential of atuzaginstat (COR388) to target the virulence factor proteases released by the bacterium.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: COR388
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2020
Details:
The International Nonproprietary Naming Committee of the World Health Organization (WHO) has selected atuzaginstat as the proposed International Nonproprietary Name, or pINN, for the company’s lead product candidate COR388.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 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.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2020
Details:
Interim analysis in phase 2/3 gain trial expected to occur in q4 2020.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 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.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 30, 2020
Details:
Open-label extension study will provide COR388 to patients for an additional 48 weeks. GAIN Trial to continue as planned following pre-specified DMC safety data review.
Lead Product(s): Atuzaginstat
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2020
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