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6 Diseases |  |
2 Trials |
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- || Review, Journal: Advances and Challenges in the Pursuit of Disease-Modifying Osteoarthritis Drugs: A Review of 2010-2024 Clinical Trials. (Pubmed Central) - Feb 26, 2025
Eleven DMOAD candidates are reviewed and critically analyzed for their potential benefit in OA treatment-Lorecivivint (SM04690), TissueGene-C, Cindunistat (SD-6010), Sprifermin, UBX0101, TPX-100, GLPG1972/S201086, Lutikizumab (ABT-981), SAR113945, MIV-711, and LNA043-and relevant challenges to their development are discussed. Six DMOADs have demonstrated statistically significant evidence of a structural or symptomatic benefit without major safety concerns in phase II and III randomized controlled trials post-2010.
- | Xtandi (enzalutamide) / Pfizer, Astellas, cirtuvivint (SM08502) / Biosplice Therap, lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: Targeting the CLK2/SRSF9 splicing axis in prostate cancer leads to decreased ARV7 expression. (Pubmed Central) - Feb 4, 2025
Both inhibitors show potent anti-proliferative effects in enzalutamide-treated or -naive PC models. Thus, targeting aberrant alternative splicing at the 3'UTR of ARV7 by disturbing the CLK2/SRSF9 axis might be a valuable therapeutic approach in late stage, ARSI-resistant PC.
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: Inhibition of the canonical Wnt/?-catenin pathway interferes with macropinocytosis to suppress pseudorabies virus proliferation. (Pubmed Central) - Jan 18, 2025
In this study, the antiviral activities of the Wnt inhibitors (Adavivint, CCT251545, FH535, and iCRT14) were identified...On the contrary, LiCl treatment significantly stimulated the protrusion formation and the PRV entry. Together, these findings suggest that suppression of the Wnt/?-catenin pathway inhibits the macropinocytosis-dependent entry of PRV, thereby providing potential targets for developing antiviral agents against PRV.
- ||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
P2 data, P3 data, Journal: Impact of Structural Severity on Outcomes in Knee Osteoarthritis: An Analysis of Data from Phase 2 and Phase 3 Lorecivivint Clinical Trials. (Pubmed Central) - Nov 4, 2024
P2, P3
LOR demonstrated greater symptomatic improvements in patients with less structurally advanced disease, indicative of an association between OA structural damage and pain. Early treatment interventions may improve outcomes and provide insight for future OA trial inclusion criteria development.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
RADIOGRAPHIC AND PAIN OUTCOMES FROM A PHASE 3 EXTENSION STUDY (OA-07) EVALUATING THE SAFETY AND EFFICACY OF REPEAT LORECIVIVINT INJECTIONS OVER 3 YEARS IN SUBJECTS WITH SEVERE KNEE OSTEOARTHRITIS (C8) - May 11, 2024 - Abstract #EULAR2024EULAR_2781;
P3
Beneficial LOR effects compared to PBO were also seen across pain and function PROs and were more pronounced in KL2 patients. PBO patients who crossed to LOR treatment showed similar benefits after 12 months, providing further evidence of potential efficacy.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
TREATMENT WITH LORECIVIVINT LEADS TO IMPROVED LONG-TERM PATIENT ACCEPTABLE SYMPTOM STATE (PASS) COMPARED TO PLACEBO: DATA FROM PHASE 3 EXTENSION TRIAL (Poster View) - Mar 29, 2024 - Abstract #EULAR2024EULAR_2358;
P3
Pain and function outcomes showed greater improvement for those subjects reporting an acceptable symptom state. These data suggest that multiple once-yearly doses of LOR are safe and may provide long-term benefits for knee OA symptoms.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
EFFECT OF LORECIVIVINT ON CARTILAGE REPAIR IN A MOUSE MODEL OF JOINT SURFACE INJURY (Poster View) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1642;
These findings indicate that LOR may promote cartilage repair, which could contribute to its OA-protective activity. Further studies with different dosing regimens are needed to confirm.
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Preclinical, Journal: Chondrocyte membrane-coated nanoparticles promote drug retention and halt cartilage damage in rat and canine osteoarthritis. (Pubmed Central) - Feb 25, 2024
Simulated synovial fluid clearance studies showed that CM-NPs loaded with a Wnt pathway inhibitor, adavivint (CM-NPs-Ada), delayed the catabolic metabolism of rat and human chondrocytes and cartilage explants under inflammatory conditions...OA progression was also mitigated by CM-NPs-Ada in a canine model of anterior cruciate ligament transection. These results demonstrate the feasibility of using chondrocyte membrane-coated nanoparticles to improve the pharmacokinetics and efficacy of anti-OA drugs.
- ||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion, Patient reported outcomes: A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES) (clinicaltrials.gov) - Feb 23, 2024
P3, N=496, Completed, Sponsor: Biosplice Therapeutics, Inc.
These results demonstrate the feasibility of using chondrocyte membrane-coated nanoparticles to improve the pharmacokinetics and efficacy of anti-OA drugs. Active, not recruiting --> Completed
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: Pharmacological inhibition of CLK2 activates YAP by promoting alternative splicing of AMOTL2. (Pubmed Central) - Dec 21, 2023
CLK2 inhibition promotes alternative splicing of the Hippo pathway protein AMOTL2, producing an exon-skipped gene product that can no longer associate with membrane-bound proteins, resulting in decreased phosphorylation and membrane localization of YAP. This study reveals a novel mechanism by which pharmacological perturbation of alternative splicing inactivates the Hippo pathway and promotes YAP-dependent cellular growth.
- ||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion, Trial completion date, Trial primary completion date: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee (clinicaltrials.gov) - Dec 20, 2023
P3, N=276, Completed, Sponsor: Biosplice Therapeutics, Inc.
This study reveals a novel mechanism by which pharmacological perturbation of alternative splicing inactivates the Hippo pathway and promotes YAP-dependent cellular growth. Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Jun 2023 | Trial primary completion date: Sep 2024 --> Jun 2023
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Review, Journal: Targeting WNT Signalling Pathways as New Therapeutic Strategies for Osteoarthritis. (Pubmed Central) - Nov 30, 2023
For example, SM04690, a novel small molecule inhibitor of WNT signalling, has demonstrated its potential in a recent phase III clinical trial as a disease-modifying osteoarthritis drug (DMOAD)...This candid review provides an introduction to WNT pathways and their crosstalk with other signalling pathways in OA development, highlighting the role of the WNT signalling pathway as a key regulator in OA development with the latest research. Particularly, we emphasize the state-of-the-art in targeting the WNT pathway as a promising therapeutic approach for OA and challenges in their development and the nanocarrier-based delivery of WNT modulators for treating OA.
- |||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion date, Trial primary completion date, Patient reported outcomes: A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES) (clinicaltrials.gov) - Nov 9, 2023
P3, N=496, Active, not recruiting, Sponsor: Biosplice Therapeutics, Inc.
Particularly, we emphasize the state-of-the-art in targeting the WNT pathway as a promising therapeutic approach for OA and challenges in their development and the nanocarrier-based delivery of WNT modulators for treating OA. Trial completion date: Oct 2023 --> Feb 2024 | Trial primary completion date: Oct 2023 --> Feb 2024
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
PK/PD data, Journal: Safety, Tolerability, and Pharmacokinetics of Same-Knee Intra-Articular Injection of Corticosteroid and Lorecivivint Within 7 (Pubmed Central) - Oct 30, 2023
P1
The PK of TCA was unaffected by previous LOR injection. These results suggest that IA administration of LOR and TCA in close time proximity is unlikely to pose a safety concern.
- ||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment closed, Patient reported outcomes: A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES) (clinicaltrials.gov) - Oct 18, 2023
P3, N=425, Active, not recruiting, Sponsor: Biosplice Therapeutics, Inc.
These results suggest that IA administration of LOR and TCA in close time proximity is unlikely to pose a safety concern. Recruiting --> Active, not recruiting
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Radiographic and Pain Outcomes from a Phase 3 Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects with Severe Osteoarthritis of the Knee (OA-07): 36 Month Single Blind and Placebo Crossover Phase Results (Room 6F/6C; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1695;
P3
A potential benefit of LOR 0.07 mg compared with PBO in medial JSW was observed 12 months after the extension baseline (second) injection, which persisted in those who completed an additional 12 months (total 36 months, 3 injections) and in PBO participants who crossed to LOR treatment. Potential LOR benefit compared to PBO is also seen across PROs with preliminary good concordance between medial JSW and pain improvement.
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Retrospective data, Review, Journal: Effect of lorecivivint on osteoarthritis: A systematic review and meta-analysis. (Pubmed Central) - Aug 14, 2023
Lorecivivint was found to significantly improve WOMAC discomfort, WOMAC function, and joint space width in osteoarthritis patients. It is anticipated to be a reliable, safe, and effective treatment option for osteoarthritis with significant therapeutic utility and potential applications.
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: Comparison of multiple synthetic chondroinductive factors in pellet culture against a TGF-? positive control. (Pubmed Central) - May 30, 2023
Similarly, two promising compounds-kartogenin and SM04690-have been reported in the literature to exhibit chondroinductive potential in vivo and in vitro; however, kartogenin was not directly compared against TGF-?...Additionally, no collagen II gene expression was detected except in the TGF-?3 positive control group. Given that the evaluated factors have confirmed efficacy in the literature, but not in the current study with a positive control, there may be value in the future identification of new chondroinductive factors that are less situation-dependent, with rigorous evaluations of their effect on chondrogenesis using positive controls.
- || cirtuvivint (SM08502) / Biosplice Therap, silmitasertib (CX-4945) / Senhwa Biosci, University of California, lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Review, Journal: Cdc2-like kinases: structure, biological function, and therapeutic targets for diseases. (Pubmed Central) - Apr 12, 2023
In this review, we comprehensively documented the structure and biological functions of CLKs in various human diseases and summarized the significance of related inhibitors in therapeutics. Our discussion highlights the most recent CLKs research, paving the way for the clinical treatment of various human diseases.
- |||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment open, Patient reported outcomes: A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES) (clinicaltrials.gov) - Dec 1, 2022
P3, N=550, Recruiting, Sponsor: Biosplice Therapeutics, Inc.
Our discussion highlights the most recent CLKs research, paving the way for the clinical treatment of various human diseases. Not yet recruiting --> Recruiting
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma, dazodalibep (HZN-4920) / Horizon Therapeutics, lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
#ACR22 #ACRambassador Abstracts: Whats in the future? @anzypanzywanzy @KarlasRheum @rheum4you . 1894: Lorecivivint: https://t.co/Tjey2ccRb7 . 0371: Lenabasum: https://t.co/qNmyZcI5Sd 2008: Dazodalibep: https://t.co/3nXyyN811j (Twitter) - Nov 6, 2022
- |||||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
New P3 trial, Patient reported outcomes: A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES) (clinicaltrials.gov) - Nov 3, 2022
P3, N=550, Not yet recruiting, Sponsor: Biosplice Therapeutics, Inc.
- |||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial primary completion date: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee (clinicaltrials.gov) - Oct 20, 2022
P3, N=276, Active, not recruiting, Sponsor: Biosplice Therapeutics, Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Aug 2022 --> Sep 2024
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
A Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial (OA-11) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderate to Severe Osteoarthritis Participants (Room 120) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_3384;
P3
Multiple potential reasons for discrepancies between this and other LOR trials were identified. These participants had the most structurally advanced disease enrolled in the program to date, with baseline mJSW < 3 mm for 68%.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Structural Severity in Knee Osteoarthritis Impacts Treatment Response: A Post Hoc Pooled Analysis of Lorecivivint Clinical Trials (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2274;
P2, P3
Participants with less structurally advanced knee OA showed greater pain treatment responses to 0.07 mg LOR compared to those with more advanced disease. These data support the hypothesis that the amount of OA structural damage is associated with the pain of knee OA and that earlier intervention may improve outcomes.Figure 1.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (OA-10) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2272;
P3
Efficacy signals were identified in participants with less severe structural disease, suggesting earlier intervention may be more effective. This trial was conducted during the COVID pandemic, and while its impact was difficult to quantify, effects on activity levels and pain PROs in knee OA patients have been reported (Larghi et al., Acta Biomed 2020; Endstrasser et al., ESSKA 2020).
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
A Phase 2, 104-Week Study of Repeat Lorecivivint Injections Evaluating Safety, Efficacy, and Bone Health Utilizing Quantitative Computed Tomography (qCT) in Knee Osteoarthritis (OA-06) (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2268;
P2
Multiple injections of LOR over 2 years did not appear to lead to any bone health adverse effects locally around the knee or regionally at spine or hip.Figure 1. Total Target Knee BMD over 104 weeksTable 1A and 1B
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma, Raylumis (tanezumab) / Eli Lilly, Pfizer
Journal: Osteoarthritis: what's new? (Pubmed Central) - Apr 30, 2022
Unfortunately, the results of the phase 2 study on the Wnt inhibitor lorecivivint are barely encouraging. However, the results of the according phase 3 study are eagerly awaited.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
USING PAIN TOLERABILITY THRESHOLDS TO CHARACTERIZE CLINICALLY MEANINGFUL TREATMENT OUTCOMES IN KNEE OSTEOARTHRITIS: POST HOC ANALYSIS OF A PHASE 2B TRIAL OF INTRA-ARTICULAR LORECIVIVINT () - Apr 29, 2022 - Abstract #OARSI2022OARSI_695;
P2
Retrospective analyses of clinical trial data that uses such cut-offs to define responders and compares the results to other frequently used methods to define response (i.e., responders defined as having 30% or 50% improvement) will help to characterize the clinical meaningfulness of the response to particular interventions and could also inform how tolerability-based cut-offs would perform in regard to assay sensitivity of clinical trials. This post hoc analysis of a Phase 2b (NCT03122860) placebo (PBO)-controlled trial of lorecivivint (LOR) (0.07 mg dose) assessed the proportion of participants who were defined as responders using pain tolerability-based cut-offs (i.e., NRS 4-7) and frequently used definitions of 30%, 50%, and 70% improvement in pain.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Lorecivivint post hoc analysis – getting the most out of clinical trial data (Markman #649) (Tiergarten) - Apr 29, 2022 - Abstract #OARSI2022OARSI_117;
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Clinical, Journal, Patient reported outcomes: Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint. (Pubmed Central) - Apr 8, 2022
P2
PBO and sham groups demonstrated equivalent patient-reported outcomes at all time points through week 24, suggesting that responses attributed to saline were contextual (ie, to the procedure) and not physiological. NCT03122860 (ClinicalTrials.gov identifier).
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: Intra-articular injection of a novel Wnt pathway inhibitor, SM04690, upregulates Wnt16 expression and reduces disease progression in temporomandibular joint osteoarthritis. (Pubmed Central) - Apr 6, 2022
Further in vitro studies revealed that SM04690 enhanced FCSCs chondrogenesis and formation of cartilaginous-like tissue in pellet cultures. Taken together, our work demonstrates that SM04690 treatment might be able to promote FCSCs chondrogenesis and repair TMJ cartilage, highlighting the therapeutic potential of intra-articular injection of SM04690 in TMJOA.
- |||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial primary completion date: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee (clinicaltrials.gov) - Mar 3, 2022
P3, N=276, Active, not recruiting, Sponsor: Biosplice Therapeutics, Inc.
Taken together, our work demonstrates that SM04690 treatment might be able to promote FCSCs chondrogenesis and repair TMJ cartilage, highlighting the therapeutic potential of intra-articular injection of SM04690 in TMJOA. Trial primary completion date: Sep 2024 --> Jun 2022
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Real-world evidence, Real-world: STRIDES-EXTRA: 3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee (clinicaltrials.gov) - Jan 9, 2022
P3, N=73, Terminated, Sponsor: Biosplice Therapeutics, Inc.
Trial primary completion date: Sep 2024 --> Jun 2022 N=300 --> 73 | Trial completion date: Jul 2026 --> Dec 2021 | Recruiting --> Terminated | Trial primary completion date: Jul 2026 --> Dec 2021; Study was terminated due to business reasons by Sponsor.
- ||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment closed, Enrollment change: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee (clinicaltrials.gov) - Jan 6, 2022
P3, N=276, Active, not recruiting, Sponsor: Biosplice Therapeutics, Inc.
N=300 --> 73 | Trial completion date: Jul 2026 --> Dec 2021 | Recruiting --> Terminated | Trial primary completion date: Jul 2026 --> Dec 2021; Study was terminated due to business reasons by Sponsor. Recruiting --> Active, not recruiting | N=500 --> 276
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Clinical, P2b data, Journal: A Phase 2b Randomized Trial of Lorecivivint, a Novel Intra-articular CLK2/DYRK1A Inhibitor and Wnt Pathway Modulator for Knee Osteoarthritis. (Pubmed Central) - Dec 16, 2021
This 24-week Phase 2b trial demonstrated the efficacy of LOR on PROs in knee OA subjects. The optimal dose for future studies was identified as 0.07 mg LOR.
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: Development of Cdc2-like Kinase 2 Inhibitors: Achievements and Future Directions. (Pubmed Central) - Dec 16, 2021
However, highly selective CLK2 inhibitors are rarely reported. This Perspective summarizes the biological roles and therapeutic potential of CLK2 along with progress on the development of CLK2 inhibitors and discusses the achievements and future prospects of CLK2 inhibitors for therapeutic applications.
- ||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial termination: A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - Nov 17, 2021
P2, N=13, Terminated, Sponsor: Biosplice Therapeutics, Inc.
This Perspective summarizes the biological roles and therapeutic potential of CLK2 along with progress on the development of CLK2 inhibitors and discusses the achievements and future prospects of CLK2 inhibitors for therapeutic applications. Completed --> Terminated; The study was terminated early due to COVID-19-related issues.
- ||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Preclinical: Join Biosplice online tomorrow at 9:15 am ET for a presentation highlighting the effect of #lorecivivint on cartilage protection in an animal model of post-traumatic OA. https://t.co/clFaF3EzWt #ACR21 (Twitter) - Nov 6, 2021
- ||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Don't miss Dr. Timothy McAlindon present an overview of the #lorecivivint program during Biosplice's Lightning Talk, now streaming on the #ACR21 virtual platform. (Twitter) - Nov 6, 2021
- || Review, Journal: Recent updates on Wnt signaling modulators: a patent review (2014-2020). (Pubmed Central) - Nov 5, 2021
Antibody based Wnt modulator, OTSA101-DTPA-90Y is currently under Phase I for the treatment of relapsed or refractory synovial sarcoma while OMP-18R5 is under Phase I for metastatic breast cancer. Ongoing preclinical and clinical trials will define the role of the Wnt pathway in different therapeutic areas and have opened new opportunities.
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: WNT Signalling in Osteoarthritis and Its Pharmacological Targeting. (Pubmed Central) - Nov 4, 2021
Pathway components whose targeting showed therapeutic potential will be highlighted and described. A specific section will be dedicated to Lorecivivint, the first inhibitor of the β-catenin-dependent pathway currently in phase III clinical trial as OA-modifying agent.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
[VIRTUAL] 6S310: Lorecivivint: A First-in-Class, Intra-articular Drug Candidate for Knee Osteoarthritis (Pathable On Demand Only - 11) - Oct 13, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_2918;
A specific section will be dedicated to Lorecivivint, the first inhibitor of the β-catenin-dependent pathway currently in phase III clinical trial as OA-modifying agent. Developed and offered by Biosplice Therapeutics
- ||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion, Enrollment change, Patient reported outcomes: STRIDES-1: A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - Oct 7, 2021
P3, N=498, Completed, Sponsor: Biosplice Therapeutics, Inc.
Developed and offered by Biosplice Therapeutics Active, not recruiting --> Completed | N=726 --> 498
- | PRI-724 / PRISM Pharma, Ohara Pharma, XAV-939 / Novartis, lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: Inhibiting Wnt/beta-catenin in CTNNB1-mutated endometrial cancer. (Pubmed Central) - Sep 29, 2021
Targeting the Wnt/β-catenin pathway in CTNNB1-mutant EC effectively inhibited proliferation and β-catenin/TCF transcriptional activity and blunted tumor progression in in vivo models. These studies suggest β-catenin transcriptional inhibitors are effective in EC and particularly in CTNNB1-mutant EC, highlighting a potential therapeutic vulnerability for treatment of CTNNB1-mutant EC.
- ||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion: A Study Evaluating the Safety, Tolerability and Efficacy of Two Injections of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - Sep 22, 2021
P2, N=101, Completed, Sponsor: Biosplice Therapeutics, Inc.
These studies suggest β-catenin transcriptional inhibitors are effective in EC and particularly in CTNNB1-mutant EC, highlighting a potential therapeutic vulnerability for treatment of CTNNB1-mutant EC. Active, not recruiting --> Completed
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
[VIRTUAL] Lorecivivint (SM04690), an Intra-articular, Small-Molecule CLK/DYRK Inhibitor That Modulates the Wnt Pathway, as a Potential Treatment for Meniscal Injuries () - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_1783;
Anti-inflammatory effects of LOR were demonstrated by inhibition of inflammatory cytokine expression. Compared with vehicle, LOR increased collagen expression in vivo, indicating potential meniscal anabolic effects.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
[VIRTUAL] Safety, Tolerability, and Pharmacokinetics of an Intra-articular Corticosteroid Injection Administered 7 Days Before or After Intra-articular Lorecivivint Injection into the Same Knee of Healthy Volunteers: An Open-Label, Parallel-Arm Study () - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_1003;
No safety signals were observed. These results suggest that IA administration of lorecivivint and triamcinolone in close proximity (7 days apart) should not pose a safety concern.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
[VIRTUAL] A Multicenter, Observational, Extension Study Evaluating the Safety, Tolerability, and Efficacy of a Single Lorecivivint Injection in Knee OA Subjects () - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_1002;
P=N/A
LOR appeared safe and well tolerated. Efficacy analyses on the described subset of completer subjects demonstrated durable symptom improvements in WOMAC Pain and Function for up to at least 12 months vs. controls.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
[VIRTUAL] Lorecivivint (SM04690), an Intra-articular, Small-Molecule CLK/DYRK Inhibitor That Modulates the Wnt Pathway, Provided Cartilage-Protective Effects in an Animal Model of Post-traumatic OA (Room 11) - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_89;
Efficacy analyses on the described subset of completer subjects demonstrated durable symptom improvements in WOMAC Pain and Function for up to at least 12 months vs. controls. LOR exhibited cartilage-protective effects and slowed disease progression in the ACLT+pMMx model in vivo and, therefore, has potential as a structure-modifying treatment for OA.