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Osteoarthritis

Osteoarthritis (OA), the most common form of arthritis, is a serious chronic disease that affects an estimated 51.9 million U.S. adults1 and 527.8 million adults globally.2 Osteoarthritis is the most prevalent joint disease and a leading source of chronic pain and disability in the United States.3,4  While often considered a disease of old age, an estimated 11.6 million U.S. adults suffering with OA are of working age (20-64 years).5 OA may affect the knees, hips, hands, spine, or great toes6; current estimates indicate that there are 24.7 million, 1 in 10 U.S. adults, with knee osteoarthritis.7

Those who live with OA experience pain, stiffness, and swelling, which limits their function and mobility; these symptoms often impact osteoarthritis suffers in their daily lives. People living osteoarthritis may experience a variety of symptoms; for some, pain is mild and occurs occasionally, while for others pain is severe and chronic. Regardless of where patients are in their OA progression, their lives are impacted when everyday activities like walking a few blocks or going up and down stairs cause too much pain. In addition, many people with OA are also diagnosed with other chronic conditions, such as heart disease, diabetes, and obesity; these comorbidities add to the burden that osteoarthritis sufferers manage.

While OA is frequently described as a “wear and tear” disease, we understand it now as a disease of the whole joint, involving the cartilage, joint lining, ligaments, and bone.6 Characteristics of the disease include: degradation of tendons, ligaments and cartilage (the cushioning tissue between joints), bony changes of the joints, and inflammation of the joint lining (called the synovium).6 Palliative therapeutics compromise on efficacy, safety or durability. Currently, there are no approved treatments which alter the course of osteoarthritis; at Biosplice, we hope to change this with lorecivivint.

References

Lorecivivint (SM04690)

Overview Mechanism of Action Data to Date

Overview

Biosplice Therapeutics has developed an injectable small-molecule inhibitor of the CDC2-like kinase (CLK) and dual-specificity tyrosine regulated kinase (DYRK) family. Lorecivivint has demonstrated improvement in pain and function as well as structural benefit.

Biosplice is conducting two large placebo-controlled phase 3 clinical trials where it hopes to demonstrate reduction in knee osteoarthritis pain with a single injection over the course of 6 months, 12 months, and beyond.

Based on the mechanism of action, Biosplice is also exploring the impact lorecivivint plays on inflammation, function, and cartilage protective effects through patient reported outcomes and structural endpoints.

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Mechanism of Action

Since its discovery in the early 1980s the Wnt pathway has increasingly been recognized as a critical cell signalling pathway that affects tissue health and homeostasis. Simply put, Wnt proteins interact with stem cells, which reside in all adult tissues, to orchestrate tissue remodelling.

Recently, increased understanding of cartilage growth mechanisms during OA progression and aging has identified Wnt signaling to play a critical role in OA pathogenesis, particularly cartilage and subchondral bone remodeling. Wnt pathway upregulation in diseased joints, which can occur through age, obeisity, trauma or overuse, contributes to cartilage degeneration and OA disease progression.

Lorecivivint potently inhibits the DYRK1A kinase, which leads to STAT3 inhibition, producing a powerful anti-inflammatory affect, resulting in both near-term pain relief and functional improvement.

Through the selective inhibition of the kinases CLK2 and DYRK1A, lorecivivint downregulates downstream Wnt pathway proteins through alternative splicing (AS). This decreases cartilage breakdown, which results in cartilage protective effects. Downregulation of the Wnt pathway also prompts mesenchymal stem cells to develop into chondrocytes. This both protects and replenishes the hyalin cartilage matrix, leading to structural improvement and long-term pain benefit.

Our novel mechanism of action is described in greater detail in our manuscript published by Osteoarthritis Research Society’s Osteoarthritis and Cartilage.

In animal models, lorecivivint has demonstrated the ability to significantly inhibit inflammation, to protect and regrow cartilage. This has produced both functional and pain improvement in numerous experiments.

The images below represent a cross section of a rat knee. The red staining represents the presence of hyalin cartilage. Both the control and treated groups received clipping of ligaments, which can erode cartilage over time. The control group (placebo-injected; represented on the left) experienced significant cartilage degradation. The treated group (lorecivivint-injected; represented on the right) showed significant cartilage improvements over the placebo-injected group. The dose used represents the equivalent of 0.07mg in humans, the dose represented in our Phase 3 approval trials.

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Data to Date

Pain

In a Phase 2b study, lorecivivint demonstrated separation from placebo and statistically significant improvements in patient-reported pain at multiple time points, with duration of response up to 24 weeks.

Function

In the same Phase 2b study, lorecivivint also demonstrated separation from placebo and statistically significant improvements in patient-reported function at multiple time points, with duration of response up to 24 weeks.

Safety and Bone Health

To date, more than 800 subjects have been treated with lorecivivint. Across all clinical trials, lorecivivint has appeared well tolerated with similar rates of adverse events compared to placebo and no evidence of systemic exposure. All SAEs observed were deemed unrelated to lorecivivint by investigators.

Structure and Cartilage

Based on the mechanism of action and cartilage protective effects in preclinical studies, Biosplice continues to investigate the full potential of lorecivivint in treating the whole joint by including structural endpoints in its Phase 3 trials

As with animal studies, the regenerative and protective effects of lorecivivint on cartilage have indirectly been demonstrated in human clinical trials. Clinicians and practicing physicians treating osteoarthritis commonly use medial joint space width (mJSW) as a measure of joint health, as decreasing mJSW predicts knee replacement in clinical practice. In Biosplice’s Phase 2a trial, patients dosed with lorecivivint showed significant increases in mJSW at a year relative to placebo subjects (prespecified unilateral symptomatic subgroup). As the figure below demonstrates, these same patients also experienced significant improvements in pain at a year, demonstrating clinical benefit as well as structural improvements.

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Publications

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

American College of Rheumatology (ACR) Annual Meeting | November 14 - 19, 2024

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

ACR 2023 | November 10 - 15, 2023

Rheumatology and Therapy | October 30, 2023

  • Safety, Tolerability, and Pharmacokinetics of Same-Knee Intra-Articular Injection of Corticosteroid and Lorecivivint Within 7 Days: An Open-Label, Randomized, Parallel-Arm Study


    Mark S. Fineman, Timothy E. McAlindon, Christian Lattermann, Christopher J. Swearingen, Sarah Kennedy, Victor A. Lopez, Ismail Simsek, Jeyanesh R. S. Tambiah, Yusuf Yazici.

Structural Severity in Knee Osteoarthritis Impacts Treatment Response: A Post Hoc Pooled Analysis of Lorecivivint Clinical Trials

ACR 2022 | November 11 - 14, 2022

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)

ACR 2022 | November 11 - 14, 2022

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

ACR 2022 | November 11 - 14, 2022

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 Participant

ACR 2022 | November 11 - 14, 2022

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 

Osteoarthritis Research Society International (OARSI) World Congress | April 07 - 10, 2022

The American Journal of Sports Medicine | January 10, 2022

  • Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint

    The American Journal of Sports Medicine. doi: 10.1177/03635465211067201


    Jeyanesh R.S. Tambiah, MD, Ismail Simsek, MD, Christopher J. Swearingen, PhD, Sarah Kennedy, PhD, Brian J. Cole, MD, Timothy E. McAlindon, MD, Yusuf Yazici MD

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

World Congress on Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases | August 26 - 28, 2021

Rheumatology and Therapy | June 08, 2021

  • Individual Participant Symptom Responses to Intra-Articular Lorecivivint in Knee Osteoarthritis: Post Hoc Analysis of a Phase 2B Trial

    Rheumatology and Therapy. doi: 10.1007/s40744-021-00316-w


    Jeyanesh R. S. Tambiah, Sarah Kennedy, Christopher J. Swearingen, Ismail Simsek, Yusuf Yazici, Jack Farr & Philip G. Conaghan

A Multicenter, Observational, Extension Study Evaluating the Safety, Tolerability, and Efficacy of a Single Lorecivivint Injection in Knee OA Subjects

European League Against Rheumatism (EULAR) | June 02 - 05, 2021

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

European League Against Rheumatism (EULAR) | June 02 - 05, 2021

ClinicoEconomics and Outcomes Research | May 21, 2021

  • Real-World Health Care Resource Utilization and Costs Among US Patients with Knee Osteoarthritis Compared with Controls

    ClinicoEconomics and Outcomes Research. doi: 10.2147/CEOR.S302289


    Angela V Bedenbaugh, Machaon Bonafede, Elizabeth H Marchlewicz, Vinson Lee, Jeyanesh Tambiah

Patient Characteristics and Factors Affecting Total Knee Replacement Decision-Making by Different Physician Types Treating Knee Osteoarthritis Patients

Osteoarthritis Research Society International (OARSI) Virtual World Congress | April 29 - May 03, 2021

The Patient Journey in Knee OA: Variations in Patient Characteristics and Treatment by Physician Specialty

Osteoarthritis Research Society International (OARSI) Virtual World Congress | April 29 - May 03, 2021

Osteoarthritis and Cartilage | February 12, 2021

  • A Phase 2b Randomized Trial of Lorecivivint, a Novel Intra-articular CLK2/DYRK1A Inhibitor and Wnt Pathway Modulator for Knee Osteoarthritis

    Osteoarthritis and Cartilage. doi: 10.1016/j.joca.2021.02.004


    Yusuf Yazici, MD, Timothy E. McAlindon, MD, MPH, Allan Gibofsky, MD, JD, Nancy E. Lane, MD, Christian Lattermann, MD, Nebojsa Skrepnik, MD, PhD, Christopher J. Swearingen, PhD, Ismail Simsek, MD, Heli Ghandehari, MS, Anita DiFrancesco, BS, BA, Jamielle Gibbs, MPH, Jeyanesh Tambiah, MD, Marc C. Hochberg, MD, MPH

Lorecivivint (SM04690), an Intra-articular, Small-Molecule CLK/DYRK1A Inhibitor That Modulates the Wnt Pathway, as a Potential Treatment for Meniscal Injuries

Orthopaedic Research Society (ORS) | February 12 - 16, 2021

Journal of Medical Economics | August 13, 2020

  • Health care resource utilization and burden of disease in a U.S. Medicare population with a principal diagnosis of osteoarthritis of the knee

    Journal of Medical Economics. doi: 10.1080/13696998.2020.1801453


    Fang Chen, Wenqing Su, Angela V. Bedenbaugh & Arman Oruc

Safety Profile of the Novel, Intra-articular Agent Lorecivivint (LOR; SM04690), a CLK/DYRK1A Inhibitor That Modulates the Wnt Pathway, in Subjects with Knee Osteoarthritis

European League Against Rheumatism (EULAR) | June 03 - 06, 2020

Lorecivivint (SM04690), an Intra-articular, Small-Molecule CLK/DYRK1A Inhibitor that Modulates the Wnt Pathway, as a Potential Treatment for Meniscal Injuries

European League Against Rheumatism (EULAR) | June 03 - 06, 2020

Arthritis & Rheumatology | May 20, 2020

  • Lorecivivint, a Novel Intra‐articular CLK/DYRK1A Inhibitor and Wnt Pathway Modulator for Treatment of Knee Osteoarthritis: A Phase 2 Randomized Trial

    Arthritis & Rheumatology. doi: 10.1002/art.41315


    Yusuf Yazici, Timothy E. McAlindon, Allan Gibofsky, Nancy E. Lane, Daniel Clauw, Morgan Jones, John Bergfeld, Christopher J. Swearingen, Anita DiFrancesco, Ismail Simsek, Jeyanesh Tambiah, Marc C. Hochberg

Lorecivivint (SM04690), a Potential Disease-Modifying Treatment for Knee Osteoarthritis, Demonstrated Cartilage-Protective Effects on Human Osteoarthritic Explants

European Workshop for Rheumatology Research (EWRR) | February 13 - 15, 2020

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

American College of Rheumatology (ACR) | November 08 - 13, 2019

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

American College of Rheumatology (ACR) | November 08 - 13, 2019

Lorecivivint (SM04690), a Potential Disease-Modifying Osteoarthritis Drug, Inhibits CLK2 and DYRK1A, Novel Molecular Regulators of Wnt Signaling, Chondrogenesis, and Inflammation

American College of Rheumatology (ACR) | November 08 - 13, 2019

Prospective Comparison of Sham vs. Placebo Injections: Data from a Trial of Lorecivivint, a Wnt Pathway Inhibitor for Knee Osteoarthritis

Cartilage Regeneration & Joint Preservation Society (ICRS) World Congress | October 05 - 08, 2019

Wnt Pathway Modulation via CLK2 and DYRK1A Inhibition by Lorecivivint, a Potential Disease-Modifying Treatment for Knee Osteoarthritis

Cartilage Regeneration & Joint Preservation Society (ICRS) World Congress | October 05 - 08, 2019

Lorecivivint (SM04690), a Potential Disease-Modifying Osteoarthritis Drug, Inhibits CLK2 and DYRK1A, Novel Molecular Regulators of Wnt Signaling, Chondrogenesis, and Inflammation

Gordon Research Conference (GRC) - Wnt Signaling Networks in Development, Disease and Regeneration | August 11 - 16, 2019

Efficacy and Safety from a Phase 2b Trial of Lorecivivint (SM04690), a Novel Intra-articular Wnt Pathway Inhibitor for the Treatment of Osteoarthritis of the Knee

European League Against Rheumatism (EULAR) | June 12 - 15, 2019

Comparison of Knee Osteoarthritis Treatment Patterns by Rheumatologists vs. Other Providers in a U.S. Administrative Claims Database

European League Against Rheumatism (EULAR) | June 12 - 15, 2019

Osteoarthritis and Cartilage | May 24, 2019

  • Modulation of the Wnt pathway through inhibition of CLK2 and DYRK1A by lorecivivint as a novel, potentially disease-modifying approach for knee osteoarthritis treatment

    Osteoarthritis and Cartilage. doi: 10.1016/j.joca.2019.05.006


    V. Deshmukh, A.L. O'Green, C. Bossard, T. Seo, L. Lamangan, M. Ibanez, A. Ghias, C. Lai, L. Do, S. Cho, J. Cahiwat, K. Chiu, M. Pedraza, S. Anderson, R. Harris, L. Dellamary, S. KC, C. Barroga, B. Melchior, B. Tam, S. Kennedy, J. Tambiah, J. Hood, Y. Yazici

An Analysis of Treatment Patterns in Knee Osteoarthritis in a U.S. Administrative Claims Database

International Society for Pharmaeconomics and Outcomes Research (ISPOR) | May 18 - 22, 2019

An Analysis of the Burden of Illness and Treatment in Knee Osteoarthritis in a U.S. Administrative Claims Database

Academy of Managed Care Pharmacy (AMCP) | March 25 - 28, 2019

A 52-Week, Randomized, Double-Blind, Phase 2 Study of an Intra-articular Wnt Pathway Inhibitor (SM04690) for Osteoarthritis

American Academy of Orthopaedic Surgeons (AAOS) | March 12 - 16, 2019

SM04690, a Potential Disease-Modifying Treatment for Knee Osteoarthritis, Functions Through Inhibition of CLK2 and DYRK1A, Novel Molecular Regulators of Wnt Signaling, Chondrogenesis, and Inflammation

Orthopaedic Research Society (ORS) | February 02 - 05, 2019

Efficacy and Safety from a Phase 2b Trial of SM04690: A Novel, Intra-Articular Wnt Pathway Inhibitor for the Treatment of Knee Osteoarthritis

International Cartilage Regeneration & Joint Preservation Society (ICRS) Summit | January 17 - 18, 2019

Efficacy and Safety from a Phase 2b Trial of SM04690, a Novel, Intra-Articular, Wnt Pathway Inhibitor for the Treatment of Osteoarthritis of the Knee

American College of Rheumatology (ACR) | October 19 - 24, 2018

Assessment of Health-Related Quality of Life in a 52-Week, Phase 2, Randomized, Controlled Trial of a Novel, Intra-Articular, Wnt Pathway Inhibitor (SM04690) for Treatment of Knee Osteoarthritis

American College of Rheumatology (ACR) | October 19 - 24, 2018

Results from a 52-week, phase 2a study of an intra-articular, small molecule Wnt pathway inhibitor, SM04690, for knee osteoarthritis

Asia Pacific League of Associations for Rheumatology (APLAR) | September 06 - 09, 2018

Treatment of Knee Osteoarthritis with SM04690 Improved WOMAC A1 “Pain on Walking” – Results from a 52 week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular, Wnt Pathway Inhibitor

European League Against Rheumatism (EULAR) | June 13 - 16, 2018

Potential Nociceptive Pain Relief of Intra-Articular Saline Control in Clinical Trials of Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Trials

European League Against Rheumatism (EULAR) | June 13 - 16, 2018

Radiographic outcomes were associated with pain and function responses: post-hoc analysis from a phase 2 study of a Wnt pathway inhibitor, SM04690, for knee osteoarthritis treatment

European League Against Rheumatism (EULAR) | June 13 - 16, 2018

Radiographic Outcomes Were Concordant with Outcome Measures in Rheumatology Osteoarthritis Research Society International (OMERACT-OARSI) Strict Response: Post-Hoc Analysis from a Phase 2 Study of a Wnt Pathway Inhibitor, SM04690, for Knee Osteoarthritis Treatment

Osteoarthritis Research Society International (OARSI) World Congress | April 26 - 29, 2018

Joint Space Width Inclusion Criteria Can Reduce Knee Osteoarthritis Trial Heterogeneity: Post-Hoc Data from a Phase 2 Trial of Wnt Pathway Inhibitor, SM04690

Osteoarthritis Research Society International (OARSI) World Congress | April 26 - 29, 2018

SM04690, a small molecule Wnt pathway inhibitor, appeared to have no deleterious effects on bone, joint, and tissue health in knee OA models

World Congress on Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases | April 19 - 22, 2018

SM04690 caused dose-dependent Wnt pathway modulation within a homeostatic range in a rat model of knee osteoarthritis

World Congress on Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases | April 19 - 22, 2018

SM04690, a Wnt Pathway Inhibitor: Anti-Inflammatory and Cartilage Protective Effects in Preclinical OA Models

International Cartilage Repair Society (ICRS) | April 09 - 12, 2018

Radiographic Outcomes Were Concordant with Pain and Function Response: Post-Hoc Analysis from a Phase 2 Study of SM04690, a Wnt Pathway Inhibitor for Knee Osteoarthritis Treatment

International Cartilage Repair Society (ICRS) | April 09 - 12, 2018

Joint Space Width Criteria Can Reduce Knee OA Trial Heterogeneity: P2 Post-Hoc Data from Wnt Pathway Inhibitor, SM04690

International Cartilage Repair Society (ICRS) | April 09 - 12, 2018

A 52 Week Randomized, Double-Blind Phase 2 Study of Intra-Articular, Wnt Pathway Inhibitor (SM04690) for Osteoarthritis

International Cartilage Repair Society (ICRS) | April 09 - 12, 2018

Results from a 52 Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular, Wnt Pathway Inhibitor (SM04690) for the Treatment of Knee Osteoarthritis

American College of Rheumatology (ACR) | November 03 - 08, 2017

Reducing Heterogeneity in OA Clinical Trials: Data from a Phase 2 Study of SM04690, a Novel, Intra-Articular, Wnt Pathway Inhibitor in Knee Osteoarthritis

American College of Rheumatology (ACR) | November 03 - 08, 2017

Osteoarthritis and Cartilage | September 15, 2017

Discovery of a Small Molecule Inhibitor of the Wnt Pathway (SM04690) as a Potential Disease Modifying Treatment for Knee Osteoarthritis

Gordon Research Conference: Wnt Signaling | August 06 - 11, 2017

Osteoarthritis and Cartilage | July 13, 2017

  • A novel Wnt pathway inhibitor, SM04690, for the treatment of moderate to severe osteoarthritis of the knee: results of a 24-week, randomized, controlled, phase 1 study

    Osteoarthritis and Cartilage, 25(10), 1598-1606. doi: 10.1016/j.joca.2017.07.006


    Y. Yazici, T.E. McAlindon, R. Fleischmann, A. Gibofsky, N.E. Lane, A.J. Kivitz, N. Skrepnik, E. Armas, C.J. Swearingen, A. DiFrancesco, J.R.S. Tambiah, J. Hood, M.C. Hochberg

  • Related Review: Osteoarthritis in 2017: Latest advances in the management of knee OA

Cartilage Regeneration in a Rat Model of Knee OA by SM04690, a Potential Disease Modifying Wnt Pathway Inhibitor

International Cartilage Repair Society Heritage Summit | June 29 - July 01, 2017

Radiographic Outcomes from a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular, Injectable, Wnt Inhibitor (SM04690) in the Treatment of Osteoarthritis of the Knee: Week 26 Interim Analysis

European League Against Rheumatism (EULAR) | June 14 - 17, 2017

Clinical Outcomes from a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular, Injectable, Wnt Pathway Inhibitor (SM04690) for the Treatment of Knee Osteoarthritis: Week 26 Interim Analysis

European League Against Rheumatism (EULAR) | June 14 - 17, 2017

Health Care Resource Use of Medicare Beneficiaries With Primary Osteoarthritis (OA) Of The Knee – A Claims Data Analysis

International Society for Pharmacoeconomics and Outcomes (ISPOR) | May 20 - 24, 2017

A Statistical Analysis Plan to Understand Osteoarthritis Patient Journey by Linking Medicare Claims Across Care Delivery Settings

International Society for Pharmacoeconomics and Outcomes (ISPOR) | May 20 - 24, 2017

Anti-inflammatory Properties of SM04690, a Small Molecule Inhibitor of the Wnt Pathway as a Potential Treatment for Knee Osteoarthritis

Osteoarthritis Research Society International (OARSI) | April 27 - 30, 2017

A Small Molecule, SM04690, has Inhibitory Effects on the Wnt Pathway and Inflammation In Vitro, With Potential Implications For the Treatment of Osteoarthritis

American College of Rheumatology (ACR) | November 11 - 16, 2016

OMERACT-OARSI ‘Strict Responders’ Analysis from Results of a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of a Novel, Intra-Articular, Injectable Wnt Inhibitor (SM04690) in the Treatment of Osteoarthritis of the Knee

Osteoarthritis Research Society International (OARSI) | March 31 - April 03, 2016

Discovery of a Small Molecule Inhibitor of the Wnt Pathway (SM04690) as a Potential Disease Modifying Treatment for Knee Osteoarthritis

Osteoarthritis Research Society International (OARSI) | March 31 - April 03, 2016

Safety, Efficacy and Biomarker Outcomes of a Novel, Intra-Articular, Injectable, Wnt Inhibitor (SM04690) in the Treatment of Osteoarthritis of the Knee: Interim, Exploratory Analysis of Results from a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study

American College of Rheumatology (ACR) | November 06 - 11, 2015

Magnetic Resonance Imaging Outcomes Using an Intra-Articular Injection (SM04690) in the Treatment of Osteoarthritis of the Knee: Interim, Exploratory Analysis of Results from a Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study

American College of Rheumatology (ACR) | November 06 - 11, 2015

Discovery of an Intra-Articular Injection Small Molecule Inhibitor of the Wnt Pathway (SM04690) As a Potential Disease Modifying Treatment for Knee Osteoarthritis

American College of Rheumatology (ACR) | November 06 - 11, 2015

Award Winning

Corporate Memberships and Collaborations

ORBIT Registry (Brigham and Women’s Hospital)

Biosplice Therapeutics is sponsoring the Osteoarthritis Registry of Biomarker and Imaging Trajectories (ORBIT). The data from this study will enhance our understanding of the natural history of knee osteoarthritis. This registry was developed in collaboration with investigators at Brigham and Women’s Hospital at Harvard Medical School.

PROGRESS OA (Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium)

Biosplice Therapeutics is a partner on the FNIH Biomarkers Consortium’s PROGRESS OA Project: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers. The project seeks to qualify imaging and biochemical biomarkers with the FDA as prognostic biomarkers of disease progression in knee osteoarthritis.

Osteoarthritis Research Society International (OARSI)

Biosplice Therapeutics is proud to be a Corporate Member of OARSI, the leading medical society for advancing the understanding, early detection, treatment, and prevention of osteoarthritis through its exclusive dedication to research.  OARSI is the only organization that is exclusively dedicated to advancing osteoarthritis research.

International Cartilage Regeneration & Joint Preservation Society (ICRS)

Biosplice Therapeutics is proud to be a Corporate Member of the ICRS, the main forum for international collaboration in cartilaginous tissue research and joint preservation. The ICRS seeks to improve patients’ quality of life, decrease their disability, and reduce the impact of degenerative joint disease on healthcare systems worldwide.

STEpUP OA (Oxford University)

Biosplice Therapeutics is pleased to support Synovial fluid To define molecular EndotyPes by Unbiased Proteomics in OA (STEpUP OA), an Oxford University-led effort, which has created a partnership to characterize the synovial fluid protein signatures of osteoarthritis patients. Data generated as part of this endeavor may potentially guide clinical decision-making by allowing for better characterization of osteoarthritis disease stages and risk of progression.

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