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Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
Phase 2a data highlight the disease modifying promise of lorecivivint based on its ability to slow joint space narrowing, while durably improving pain and function over one year.
Lead Product(s): Lorecivivint
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
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 May 22, 2020
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