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Details:
CY6463 (zagociguat), is a once-daily, oral, clinical-stage investigational medicine with the potential to positively impact both peripheral and central nervous system components of mitochondrial diseases.
Lead Product(s): Zagociguat
Therapeutic Area: Genetic Disease Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2023
Details:
The financing will support the development of the Phase 2 soluble guanylate cyclase (sGC) stimulator CY6463 (zagociguat) in MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes) and other genetic mitochondrial diseases.
Lead Product(s): Zagociguat
Therapeutic Area: Rare Diseases and Disorders Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Invus
Deal Size: $81.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing July 31, 2023
Details:
Under the agreement, Tisento will develop CY6463 (zagociguat), sGC stimulator, to treat Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes syndrome (MELAS) and other diseases associated with mitochondrial dysfunction and advance CY3018.
Lead Product(s): Zagociguat
Therapeutic Area: Genetic Disease Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tisento Therapeutics
Deal Size: $8.0 million Upfront Cash: $8.0 million
Deal Type: Divestment July 31, 2023
Details:
Under the agreement, new company (NewCo) will develop CY6463 (zagociguat), sGC stimulator, to treat Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes syndrome (MELAS) and other diseases associated with mitochondrial dysfunction and advance CY3018.
Lead Product(s): Zagociguat
Therapeutic Area: Rare Diseases and Disorders Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $8.0 million Upfront Cash: $8.0 million
Deal Type: Divestment May 11, 2023
Details:
The proceeds are used to support the ongoing operations regarding Zagociguat, a CNS-penetrant sGC stimulator that has shown rapid improvements across a range of endpoints reflecting multiple domains of disease activity, including mitochondrial disease-associated biomarkers.
Lead Product(s): Zagociguat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Peter Hecht
Deal Size: $5.0 million Upfront Cash: $5.0 million
Deal Type: Agreement April 03, 2023
Details:
CY6463 (zagociguat), is the first CNS-penetrant sGC stimulator to be developed as a symptomatic and potentially disease-modifying therapy for serious diseases that involve the CNS.
Lead Product(s): Zagociguat
Therapeutic Area: Genetic Disease Product Name: CY6463
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2023
Details:
Data from 14-day study demonstrated that CY6463 was safe and well tolerated, with no reports of SAEs, severe adverse events AEs, or treatment discontinuation due to AEs. Study data demonstrate a strong effect on cognitive performance after two weeks of 15mg once-daily dosing.
Lead Product(s): Zagociguat
Therapeutic Area: Psychiatry/Psychology Product Name: CY6463
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Details:
Data for CY6463, a first-in-class, CNS-penetrant, sGC stimulator, demonstrate safety and positive effects across biomarkers of disease in MELAS patients.
Lead Product(s): Zagociguat
Therapeutic Area: Rare Diseases and Disorders Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Details:
CY6463 is the first CNS-penetrant sGC stimulator, as a positive allosteric modulator to be developed as a symptomatic and potentially disease-modifying therapy for serious CNS diseases.
Lead Product(s): Zagociguat
Therapeutic Area: Neurology Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
Research from preclinical studies demonstrates treatment with its lead soluble guanylate cyclase (sGC) stimulator, CY6463, was associated with improved cellular energetics and reduced inflammation in preclinical models of mitochondrial disease.
Lead Product(s): Zagociguat
Therapeutic Area: Genetic Disease Product Name: CY6463
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Details:
CY6463 was well tolerated, with no reports of serious adverse events (SAEs) or treatment discontinuation due to adverse events (AEs); oral, once-daily administration provided expected CNS exposure.
Lead Product(s): Zagociguat
Therapeutic Area: Neurology Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
C6463-202 will evaluate the safety, tolerability, PK, and PD of CY6463 vs placebo in participants with ADv. Participants will be randomized to receive approximately 87 sequential days of study drug once daily and will complete 7 scheduled visits over the course of the study.
Lead Product(s): Zagociguat
Therapeutic Area: Neurology Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
IXICO has been selected by Cyclerion Therapeutics, Inc., a new client, to support the company's Phase IIa clinical trial to investigate CY6463 for treatment of individuals with Alzheimer's disease.
Lead Product(s): Zagociguat
Therapeutic Area: Neurology Product Name: CY6463
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cyclerion Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 02, 2021
Details:
The presentation detailed the application of translational biomarkers to guide clinical activities for IW-6463, the Company’s therapeutic candidate for CNS diseases.
Lead Product(s): Zagociguat
Therapeutic Area: Neurology Product Name: IW-6463
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2020