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- ||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion, Enrollment change: STRIDES-X-ray: A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - Sep 21, 2021
P3, N=501, Completed, Sponsor: Biosplice Therapeutics, Inc.
Active, not recruiting --> Completed | N=725 --> 501
- |||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment open, 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) - Jul 18, 2021
P3, N=300, Recruiting, Sponsor: Biosplice Therapeutics, Inc.
Active, not recruiting --> Completed | N=725 --> 501 Not yet recruiting --> Recruiting
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial primary completion date: 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) - Jul 13, 2021
P2, N=13, Completed, Sponsor: Biosplice Therapeutics, Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Dec 2020 --> Jul 2020
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Journal: A Small-Molecule Inhibitor of the Wnt Pathway, Lorecivivint (SM04690), as a Potential Disease-Modifying Agent for the Treatment of Degenerative Disc Disease. (Pubmed Central) - Jun 23, 2021
The current therapeutic options for DDD are pain management and surgical intervention; there are no approved therapies that alter the progression of DDD. Our data support advancing LOR into clinical development as an injectable, small-molecule, potential disease-modifying treatment for DDD in humans.
- |||||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
New P3 trial, 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) - Jun 18, 2021
P3, N=300, Not yet recruiting, Sponsor: Biosplice Therapeutics, Inc.
- |||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
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) - Jun 14, 2021
P3, N=500, Recruiting, Sponsor: Biosplice Therapeutics, Inc.
Our data support advancing LOR into clinical development as an injectable, small-molecule, potential disease-modifying treatment for DDD in humans. Trial completion date: Sep 2022 --> Sep 2024 | Trial primary completion date: Sep 2022 --> Sep 2024
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Clinical, P2b data, Retrospective data, Journal: Individual Participant Symptom Responses to Intra-Articular Lorecivivint in Knee Osteoarthritis: Post Hoc Analysis of a Phase 2B Trial. (Pubmed Central) - Jun 9, 2021
P2
Trial completion date: Sep 2022 --> Sep 2024 | Trial primary completion date: Sep 2022 --> Sep 2024 LOR (0.07 mg) demonstrated improved PRO threshold responses across single and composite measures of pain, function, and patient global assessment compared with PBO, with benefits sustained to 24 weeks.
- 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 (Room 6) - Jun 7, 2021 - Abstract #EULAR2021EULAR_4606;
- |||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Clinical, P3 data: A single dose of LORECIVIVINT IA (Wnt pathway modulator) in Phase 3 study in knee OA: mild improvement of WOMAC pain -8.16[-15.60, -0.71] P=0.032 and function -9.47[-17.09, -1.84] P=0.015 at 6 and 12months with no particular safety signal. #POS0278 #EULAR2021 @RheumNow (Twitter) - Jun 5, 2021
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
[VIRTUAL] LORECIVIVINT (SM04690), AN INTRA-ARTICULAR, SMALL-MOLECULE CLK2/DYRK1A INHIBITOR THAT MODULATES THE WNT PATHWAY, AS A POTENTIAL TREATMENT FOR MENISCAL INJURIES (Posters Viewing) - May 21, 2021 - Abstract #EULAR2021EULAR_2889;
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.
- || sprifermin (AS-902330) / EMD Serono, lorecivivint (SM04690) / Samumed, Samil Pharma
Review, Journal: Promising targets for therapy of osteoarthritis: a review on the Wnt and TGF-β signalling pathways. (Pubmed Central) - May 6, 2021
Likewise, low levels of Wnt activity appear important to sustain chondrocyte viability but excessive activation is associated with progressive joint damage. Emerging clinical data suggest some potential for the use of sprifermin, a recombinant forms of fibroblast growth factor 18, a distant TGF-β superfamily member, and for lorecivivint, a Wnt pathway modulator.
- lorecivivint (SM04690) / Samumed, Samil Pharma
[VIRTUAL] Lorecivivint (SM04690), an intra-articular, small-molecule CLK/DYRK1A inhibitor that modulates the WNT pathway, as a potential treatment for meniscal injuries () - May 3, 2021 - Abstract #OARSI2021OARSI_125;
The Wnt signaling pathway has been shown to be regulated during meniscal development, suggesting that manipulation of this pathway may influence the regenerative capacity of the meniscus. Lorecivivint (LOR; SM04690), an intra-articular (IA), small-molecule CLK/DYRK1A inhibitor that modulates the Wnt pathway, was evaluated in preclinical studies to determine its protective and anabolic effects in ex vivo explants and in a rat model of chemically induced inflammatory meniscal degeneration.
- 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 (Room 6) - Apr 6, 2021 - Abstract #EULAR2021EULAR_1859;
P=N/A, P2
From these data, LOR appeared to be safe and well tolerated. A post hoc-analyzed subset of completer subjects treated with a single 0.07 mg LOR injection reported durable symptom improvements in WOMAC Pain and Function for up to at least 12 months versus control subjects.
- lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
[VIRTUAL] LORECIVIVINT (SM04690), AN INTRA-ARTICULAR, SMALL-MOLECULE CLK2/DYRK1A INHIBITOR THAT MODULATES THE WNT PATHWAY, PROVIDED CARTILAGE-PROTECTIVE EFFECTS IN AN ANIMAL MODEL OF POST-TRAUMATIC OA (Room 3) - Apr 6, 2021 - Abstract #EULAR2021EULAR_1335;
A post hoc-analyzed subset of completer subjects treated with a single 0.07 mg LOR injection reported durable symptom improvements in WOMAC Pain and Function for up to at least 12 months versus control subjects. 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.
- | lorecivivint (SM04690) / Samumed
Journal: Lorecivivint, an intra-articular potential disease-modifying osteoarthritis drug. (Pubmed Central) - Mar 18, 2021
While the Phase 2A trial did not meet its primary endpoint, pre-planned analyses did identify a target population for further evaluation of its potential as a DMOAD. Phase 3 trials are ongoing, but this intra-articular drug is currently considered safe and well-tolerated, with no significant reported systemic side effects.
- ||| sprifermin (AS-902330) / EMD Serono, lorecivivint (SM04690) / Samumed
I can easily see you bettering the current companies/thinking in the space, if desired: @Samumed_LLC - Lorecivivint (Wnt pathway) @Merck - Sprifermin (FGF-18) Histogen, Invossa etc. Various stem cell therapies EGFR signalling Maybe @bengoertzel and AGI can play a role? (Twitter) - Mar 1, 2021
- ||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment closed, Trial completion date, Trial primary completion date, 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) - Feb 25, 2021
P3, N=726, Active, not recruiting, Sponsor: Samumed LLC
Phase 3 trials are ongoing, but this intra-articular drug is currently considered safe and well-tolerated, with no significant reported systemic side effects. Recruiting --> Active, not recruiting | Trial completion date: Apr 2021 --> Sep 2021 | Trial primary completion date: Apr 2021 --> Sep 2021
- PRI-724 / PRISM Pharma, Ohara Pharma, XAV-939 / Novartis, lorecivivint (SM04690) / Samumed
[VIRTUAL] Targeting Wnt/beta-catenin signaling in CTNNB1-mutant endometrial cancer () - Jan 29, 2021 - Abstract #SGO2021SGO_852;
Further, the inhibitor SM04690 blunted tumor progression in in vivo models. These studies suggest beta-catenin transcriptional inhibitors are effective in EC and have a more significant effect in CTNNB1- mutant than -wildtype EC.
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion: 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) - Jan 14, 2021
P2, N=13, Completed, Sponsor: Samumed LLC
These studies suggest beta-catenin transcriptional inhibitors are effective in EC and have a more significant effect in CTNNB1- mutant than -wildtype EC. Recruiting --> Completed
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion, Trial completion date, Trial primary completion date: Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers (clinicaltrials.gov) - Jan 11, 2021
P1, N=40, Completed, Sponsor: Samumed LLC
Recruiting --> Completed Recruiting --> Completed | Trial completion date: Apr 2021 --> Dec 2020 | Trial primary completion date: Apr 2021 --> Dec 2020
- || lorecivivint (SM04690) / Samumed
Clinical, P2 data, Journal: Lorecivivint, a Novel Intra-articular CLK/DYRK1A Inhibitor and Wnt Pathway Modulator for Treatment of Knee Osteoarthritis: A Phase 2 Randomized Trial. (Pubmed Central) - Jan 7, 2021
Recruiting --> Completed | Trial completion date: Apr 2021 --> Dec 2020 | Trial primary completion date: Apr 2021 --> Dec 2020 This Phase 2a, proof-of-concept trial did not meet its primary endpoint; however, it identified a target population in which to evaluate the potential efficacy of lorecivivint.
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
New P1 trial: Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers (clinicaltrials.gov) - Oct 22, 2020
P1, N=40, Recruiting, Sponsor: Samumed LLC
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion date: 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 11, 2020
P2, N=100, Active, not recruiting, Sponsor: Samumed LLC
This Phase 2a, proof-of-concept trial did not meet its primary endpoint; however, it identified a target population in which to evaluate the potential efficacy of lorecivivint. Trial completion date: Aug 2020 --> Sep 2021
- | lorecivivint (SM04690) / Samumed
Review, Journal: Wnt signaling: a promising target for osteoarthritis therapy. (Pubmed Central) - Sep 10, 2020
P1
Notably, a recent phase I clinical trial (NCT02095548) demonstrated the potential of SM04690, a small-molecule inhibitor of the Wnt signaling pathway, as a disease-modifying oseoarthritis drug (DMOAD). This review summarizes the role and mechanism of Wnt signaling and related molecules in regulating OA progression, with a view to accelerating the translation of such evidence into the development of strategies for OA treatment, particularly with respect to potential applications of molecules targeting the Wnt signaling pathway.
- |||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment open: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee (clinicaltrials.gov) - Sep 2, 2020
P3, N=500, Recruiting, Sponsor: Samumed LLC
This review summarizes the role and mechanism of Wnt signaling and related molecules in regulating OA progression, with a view to accelerating the translation of such evidence into the development of strategies for OA treatment, particularly with respect to potential applications of molecules targeting the Wnt signaling pathway. Not yet recruiting --> Recruiting
- | lorecivivint (SM04690) / Samumed
Journal: Modulation of the Wnt pathway through inhibition of CLK2 and DYRK1A by lorecivivint as a novel, potentially disease-modifying approach for knee osteoarthritis treatment. (Pubmed Central) - Aug 29, 2020
Lorecivivint inhibition of CLK2 and DYRK1A suggested a novel mechanism for Wnt pathway inhibition, enhancing chondrogenesis, chondrocyte function, and anti-inflammation. Lorecivivint shows potential to modify structure and improve symptoms of knee OA.
- |||||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
New P3 trial: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee (clinicaltrials.gov) - Aug 20, 2020
P3, N=500, Not yet recruiting, Sponsor: Samumed LLC
- ||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment closed: STRIDES-X-ray: A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - Aug 7, 2020
P3, N=725, Active, not recruiting, Sponsor: Samumed LLC
Lorecivivint shows potential to modify structure and improve symptoms of knee OA. Recruiting --> Active, not recruiting
- | lorecivivint (SM04690) / Samumed
Journal: The role of Wnt signaling pathway in osteoarthritis via the dual-targeted regulation of cartilage and subchondral bone (Pubmed Central) - Aug 7, 2020
The regulation of metabolism and function of cartilage and subchondral bone and crosstalk between them is through interactions among Wnt signaling pathway and molecules of other signaling. Therefore, it plays an vital role in the occurrence and development of OA and is expected to become a new target of OA treatment through intervention and regulation of Wnt signaling pathway.
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion date, Trial primary completion date: 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) - Jul 21, 2020
P2, N=15, Recruiting, Sponsor: Samumed LLC
Therefore, it plays an vital role in the occurrence and development of OA and is expected to become a new target of OA treatment through intervention and regulation of Wnt signaling pathway. Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020
- | lorecivivint (SM04690) / Samumed
Journal: INHIBITION OF WINGLESS-RELATED INTEGRATION SITE (WNT) SIGNALLING MAY TREAT OSTEOARTHRITIS OF THE KNEE. (Pubmed Central) - Jul 19, 2020
Recently, inhibition of the Wnt/beta-catenin signaling pathway with lorecivivint (LOR; SMO496) was found to prevent the deterioration of the cartilage in preclinical models of posttraumatic OA...LOR has been tested in both Phase I and Phase 2 trials, and a dose of 0.07ug/kg administered through intra-articular injection reduced pain and preserved the articular joint space as assessed by radiograph. Therefore, reduction in Wnt signaling in the knee joint may reduce signs and symptoms and alter the course of osteoarthritis.
- |||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment open, 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) - Jun 22, 2020
P3, N=726, Recruiting, Sponsor: Samumed LLC
Therefore, reduction in Wnt signaling in the knee joint may reduce signs and symptoms and alter the course of osteoarthritis. Not yet recruiting --> Recruiting
- lorecivivint (SM04690) / Samumed
[VIRTUAL] LORECIVIVINT (SM04690), A POTENTIAL DISEASE-MODIFYING TREATMENT FOR KNEE OSTEOARTHRITIS, DEMONSTRATED CARTILAGE-PROTECTIVE EFFECTS ON HUMAN OSTEOARTHRITIC EXPLANTS () - May 22, 2020 - Abstract #EULAR2020EULAR_3922;
These cartilage-protective effects support the development of LOR as a potential disease-modifying treatment for knee OA. Human trials are ongoing.
- lorecivivint (SM04690) / Samumed
[VIRTUAL] THE NOVEL, INTRA-ARTICULAR CLK/DYRK1A INHIBITOR LORECIVIVINT (LOR; SM04690), WHICH MODULATES THE WNT PATHWAY, IMPROVED RESPONDER OUTCOMES IN SUBJECTS WITH KNEE OSTEOARTHRITIS: A POST HOC ANALYSIS FROM A PHASE 2B TRIAL (Poster View) - May 22, 2020 - Abstract #EULAR2020EULAR_2561;
LOR demonstrated significantly higher odds of achieving and maintaining improvements in PROs at 30% and 50% thresholds. Phase 3 studies of 0.07 mg LOR are ongoing.
- lorecivivint (SM04690) / Samumed
[VIRTUAL] LORECIVIVINT (SM04690), AN INTRA-ARTICULAR, SMALL-MOLECULE CLK/DYRK1A INHIBITOR THAT MODULATES THE WNT PATHWAY, AS A POTENTIAL TREATMENT FOR MENISCAL INJURIES () - May 22, 2020 - Abstract #EULAR2020EULAR_2154;
Anti-inflammatory effects of LOR were demonstrated by inhibition of inflammatory cytokine expression. Compared to vehicle, LOR increased expression of collagens in vivo, indicating potential meniscal anabolic effects.
- |||| lorecivivint (SM04690) / Samumed
Phase 2 RCT of Lorecivivint, a Novel Intra‐articular CLK/DYRK1A Inhibitor & Wnt Pathway Modulator for Knee #Osteoarthritis. Symptom benefit only in subgrp w/ unilateral #OA & w/out widespread pain; some + mJSW findings. https://t.co/XpdsuhMGia @OARSInews @OARSI_YI @ACRheum (Twitter) - May 20, 2020
- |||||||||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
New P3 trial, 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) - May 11, 2020
P3, N=726, Not yet recruiting, Sponsor: Samumed LLC
- ||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis (clinicaltrials.gov) - Apr 17, 2020
P=N/A, N=703, Completed, Sponsor: Samumed LLC
Compared to vehicle, LOR increased expression of collagens in vivo, indicating potential meniscal anabolic effects. Active, not recruiting --> Completed | N=2000 --> 703 | Trial completion date: May 2023 --> Oct 2019 | Trial primary completion date: May 2023 --> Oct 2019
- || lorecivivint (SM04690) / Samumed
Review, Journal: Review Article: Is Wnt Signaling an Attractive Target for the Treatment of Osteoarthritis? (Pubmed Central) - Apr 13, 2020
The current concept, based on genetic and functional studies, indicates that tight regulation of Wnt signaling in cartilage is essential to keep the joint healthy. In this review, we discuss how this concept has evolved, provide insights into the regulation of Wnt signaling, in particular by Wnt modulators such as frizzled-related protein and DOT1-like histone lysine methyltransferase, and summarize preclinical evidence and molecular mechanisms of lorecivivint, the first Wnt antagonist in clinical development for osteoarthritis.
- lorecivivint (SM04690) / Samumed
[VIRTUAL] LORECEVIVINT, A POTENTIAL DISEASE-MODIFYING TREATMENT FOR KNEE OSTEOARTHRITIS- FACTORS DRIVING WOMAC PAIN SUBSCORE CHANGES - A POST HOC ANALYSIS OF PHASE 2B DATA () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_2061;
In this post hoc analysis, following LOR treatment, Pain NRS exhibited the greatest ES compared to PBO. ‘Active’ items demonstrated greater ES than ‘static’ items and the full WOMAC Pain domain, providing support for the hypothesized dimensional constructs in knee OA pain assessment.
- lorecivivint (SM04690) / Samumed
[VIRTUAL] ITEMS DRIVING WOMAC PAIN SUBSCORE CHANGES DUE TO LORECIVIVINT, A POTENTIAL DISEASE-MODIFYING TREATMENT FOR KNEE OSTEOARTHRITIS: A POST HOC ANALYSIS OF PHASE 2B TRIAL DATA (Poster Tour) - Mar 5, 2020 - Abstract #EULAR2020EULAR_1096;
These effect sizes were enhanced in the target population with fixed baseline JSW and without widespread pain for all scores relative to the FAS. WOMAC ‘active’ questions demonstrated greater effect sizes with LOR treatment than ‘static’ questions and the full WOMAC Pain domain, providing support for the hypothesized dimensional constructs in knee OA pain assessment.
- |||| lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Trial completion date, Trial primary completion date: STRIDES-X-ray: A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - Mar 5, 2020
P3, N=725, Recruiting, Sponsor: Samumed LLC
WOMAC ‘active’ questions demonstrated greater effect sizes with LOR treatment than ‘static’ questions and the full WOMAC Pain domain, providing support for the hypothesized dimensional constructs in knee OA pain assessment. Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Dec 2020 --> Jun 2021
- lorecivivint (SM04690) / Samumed
[VIRTUAL] INTEGRATED SAFETY SUMMARY OF THE NOVEL, INTRA-ARTICULAR AGENT LORECIVIVINT (SM04690), A CLK/DYRK1A INHIBITOR THAT MODULATES THE WNT PATHWAY, IN SUBJECTS WITH KNEE OSTEOARTHRITIS (Maini) - Mar 4, 2020 - Abstract #EULAR2020EULAR_248;
P1, P2
In exposure to date of 848 subjects, IA LOR for the treatment of knee OA appeared to be safe and well tolerated. These data support the continued evaluation of LOR as a potential treatment for knee OA.
- lorecivivint (SM04690) / Samumed
LORECIVIVINT (SM04690), A POTENTIAL DISEASE-MODIFYING TREATMENT FOR KNEE OSTEOARTHRITIS, DEMONSTRATED CARTILAGE-PROTECTIVE EFFECTS ON HUMAN OSTEOARTHRITIC EXPLANTS (Jubilee Hall KU Leuven) - Feb 28, 2020 - Abstract #EWRR2020EWRR_139;
These cartilage-protective effects support the development of LOR as a potential disease-modifying treatment for knee OA. Human trials are ongoing.
- lorecivivint (SM04690) / Samumed
Preclinical development and mechanism of action of Lorecivivint, a Wnt pathway antagonist (HOGC 02.22, Leuven) - Feb 28, 2020 - Abstract #EWRR2020EWRR_94;
- || lorecivivint (SM04690) / Biosplice Therap, Samil Pharma
Enrollment closed: 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) - Jan 2, 2020
P2, N=100, Active, not recruiting, Sponsor: Samumed LLC
Human trials are ongoing. Recruiting --> Active, not recruiting
- lorecivivint (SM04690) / Samumed
Innovation Theater A: “The Wnt Factor”: Lorecivivint’s Novel Approach to Knee Osteoarthritis (Building B, Level 1, Hall B2-4, Booth 361) - Oct 19, 2019 - Abstract #ACRARHP2019ACR_4152;
Recruiting --> Active, not recruiting Presented by Samumed LLC These non-CME accredited presentations have been planned and will be implemented with the requirements of the FDA and applicable standards of the PhRMA Code on Interactions with Healthcare Professionals.
- lorecivivint (SM04690) / Samumed
The Novel, Intra-articular CLK/DYRK1A Inhibitor Lorecivivint (LOR; SM04690), Which Modulates the Wnt Pathway, Improved Responder Outcomes in Subjects with Knee Osteoarthritis: A Post Hoc Analysis from a Phase 2b Trial (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2238;
Phase 3 studies are ongoing. Figure.
- lorecivivint (SM04690) / Samumed
Safety Profile to Date of the Novel, Intra-articular Agent Lorecivivint (LOR; SM04690), a CLK/DYRK1A Inhibitor That Modulates the Wnt Pathway, in Subjects with Knee Osteoarthritis (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2237;
P1, P2
These data support the continued evaluation of LOR as a treatment for OA. Figure 1.
- lorecivivint (SM04690) / Samumed
Subject Enrichment Criteria for Phase 3 Studies of Lorecivivint (SM04690), a Potential Disease-Modifying Knee Osteoarthritis Drug: A Post Hoc Study on the Effects of Baseline Comorbid Pain and Joint Space Width on Patient-Reported Outcomes (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2219;
These increased point estimates and confidence intervals may help to improve power calculations and create more homogenous populations to test new therapies. Figure 1.