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Cyclerion Therapeutics
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U.S.A
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301 Binney Street Cambridge, MA 02142
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857-327-8778

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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