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The funding aims to focus on the clinical development of their product SM07883, which is a DYRK1A inhibitor. Currently, it is being evaluated in preclinical trial studies for the treatment of Tauopathies including Alzheimer's Disease and Frontotemporal Dementia.


Lead Product(s): SM07883

Therapeutic Area: Neurology Product Name: SM07883

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Roskamp Institute

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Funding March 08, 2024

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Results from the study continue to support the potential efficacy of multiple injections of SM04690 (lorecivivint) in delaying structural progression and providing symptomatic benefic.


Lead Product(s): Lorecivivint

Therapeutic Area: Immunology Product Name: SM04690

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 15, 2022

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SM04690 (lorecivivint), demonstrated clinical efficacy in earlier, less structurally damaged patients, although these trials fell short of reaching statistical significance in their primary endpoints of Pain NRS (daily pain score) at week 12 with all subjects.


Lead Product(s): Lorecivivint

Therapeutic Area: Immunology Product Name: SM04690

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 11, 2022

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Cirtuvivint (SM08502) is a small-molecule inhibitor of the CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases that are emerging as key contributors to numerous forms of cancer.


Lead Product(s): Cirtuvivint

Therapeutic Area: Oncology Product Name: SM08502

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 September 10, 2022

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Cirtuvivint is a small-molecule inhibitor of the CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases that are emerging as key contributors to numerous forms of cancer.


Lead Product(s): Cirtuvivint,Abiraterone Acetate,Prednisone

Therapeutic Area: Oncology Product Name: SM08502

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 November 17, 2021

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Lorecivivint has showed structural benefit, as measured by X-ray analysis of medial joint space width, 52 weeks following a single injection in the target knee. Lorecivivint has appeared safe and well-tolerated in studies to date.


Lead Product(s): Lorecivivint

Therapeutic Area: Musculoskeletal Product Name: SM04690

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Haisco Pharmaceutical

Deal Size: $140.0 million Upfront Cash: $20.0 million

Deal Type: Licensing Agreement September 15, 2021

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Biosplice showed that study subjects dosed with 0.07 mg lorecivivint were over two times more likely to meet the criteria for OMERACT-OARSI Strict Response, a measure that includes 50% improvement in pain or function, than those on placebo at 12 weeks.


Lead Product(s): Lorecivivint

Therapeutic Area: Musculoskeletal Product Name: SM04690

Highest Development Status: 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

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In this 24-week clinical trial, Biosplice’s groundbreaking knee OA drug candidate, lorecivivint, met primary endpoints of Pain NRS (daily pain measurement) at both 12 and 24-week timepoints.


Lead Product(s): Lorecivivint

Therapeutic Area: Musculoskeletal Product Name: SM04690

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 26, 2021

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Lorecivivint (SM04690) is currently being evaluated in Phase 3 pivotal trials for the treatment of knee osteoarthritis in the United States. Samil will lead development, regulatory and commercialization activities for lorecivivint in the Republic of Korea.


Lead Product(s): Lorecivivint

Therapeutic Area: Musculoskeletal Product Name: SM04690

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Samil Pharmaceutical

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement April 22, 2021

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