A Phase 3, 16-Week, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint 0.07 mg Dose in the Target Knee Joint of Subjects With Moderate to Severe Osteoarthritis Pain of the Knee

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target (most painful) knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize standard outcomes to evaluate the safety and efficacy of lorecivivint.

Start Date18 Nov 2022

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

[+1]

NCT04931667

/ TerminatedPhase 3

A 3-Year, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Intra-articular Lorecivivint in Subjects With Osteoarthritis of the Knee in a Real-World Setting (STRIDES-EXTRA)

This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.

Start Date15 Jul 2021

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

NCT04598542

/ CompletedPhase 1

Open-Label, Parallel-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Corticosteroid Intra Articular Injection Given 7 Days Before or 7 Days After Lorecivivint Intra-articular Injection Into the Knee of Healthy Volunteers

This study will be an open-label, parallel-arm study to determine if a prior intra-articular (IA) injection of lorecivivint (LOR) affects the safety, tolerability, and/or pharmacokinetics (PK) of a subsequent IA injection of the corticosteroid triamcinolone acetonide (TA) into the same knee, and to determine if a prior IA injection of TA affects the safety or tolerability of a subsequent IA injection of LOR into the same knee.

Start Date13 Oct 2020

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

100 Clinical Results associated with Lorecivivint

100 Translational Medicine associated with Lorecivivint

100 Patents (Medical) associated with Lorecivivint

Literatures (Medical) associated with Lorecivivint

01 Feb 2025·Veterinary Microbiology

Inhibition of the canonical Wnt/β-catenin pathway interferes with macropinocytosis to suppress pseudorabies virus proliferation

Article

Author: Han, Yu ; Wang, Ting ; Yang, Zengqi ; Wang, Chongyang ; He, Qingrun ; Song, Houhui ; Hu, Ruochen ; Hou, Qili ; Duan, Liuyuan ; Yang, Yongchun

Pseudorabies virus (PRV) is one of the highly contagious pathogens causing significant economic losses to the swine industry worldwide. More importantly, PRV is becoming a potential "life-threatening zoonosis" since the human-originated PRV strain was first isolated in 2019. Previously we found that the canonical Wnt/β-catenin pathway facilitates PRV proliferation, while the underlying mechanism remains unknown. In this study, the antiviral activities of the Wnt inhibitors (Adavivint, CCT251545, FH535, and iCRT14) were identified. Applying these inhibitors significantly inhibited PRV proliferation in different cell lines. Among them, CCT251545 presented the strongest anti-PRV activity with IC₅₀ values less than 200 nM. Our in vivo studies showed that treatment with CCT251545 remarkedly decreased the viral loads and protected mice challenged with PRV. Further study found that CCT251545 neither had a virucidal effect nor affected viral adsorption while mainly interfering with the entry process of the PRV life cycle. Using the FITC-dextran uptake assay, we found that CCT251545 inhibited macropinocytosis. The formation of membrane protrusions, which is important for macropinocytosis, was also inhibited by CCT251545. Consistent with this, knockout of β-catenin suppressed the PRV macropinocytosis and the formation of protrusions. On the contrary, LiCl treatment significantly stimulated the protrusion formation and the PRV entry. Together, these findings suggest that suppression of the Wnt/β-catenin pathway inhibits the macropinocytosis-dependent entry of PRV, thereby providing potential targets for developing antiviral agents against PRV.

01 Dec 2023·Rheumatology and Therapy

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

Article

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

INTRODUCTIONKnee osteoarthritis (OA) is a common painful disorder. Intra-articular (IA) corticosteroid injections are frequently prescribed to treat knee pain. Lorecivivint (LOR), a novel IA cdc2-Like Kinase (CLK)/Dual-Specificity Tyrosine Phosphorylation-Regulated Kinase (DYRK) inhibitor thought to modulate Wnt and inflammatory pathways, has appeared safe and demonstrated improved patient-reported outcomes compared with placebo. While LOR is proposed for stand-alone use, in clinical practice, providers might administer LOR in close time proximity to IA corticosteroid. This open-label, parallel-arm, healthy volunteer study assessed potential short-term safety, tolerability and pharmacokinetic (PK) interactions between IA LOR and triamcinolone acetonide (TCA) administered 7 days apart.METHODSHealthy volunteers were randomized to Treatment Sequence 1 (IA 40 mg TCA followed by IA 0.07 mg LOR) or Treatment Sequence 2 (IA 0.07 mg LOR followed by IA 40 mg TCA). Treatment-emergent adverse events (TEAEs) were categorized by "epoch", with epoch 1 spanning from first until second injection, and epoch 2 spanning from second injection until end of study. Plasma PK was assessed pre injection and out to 22 days after to assess PK treatment interaction.RESULTSA total of 18 TEAEs were reported by 11 (27.5%) of 40 enrolled participants, and there were no serious adverse events. Thirteen TEAEs were reported in Treatment Sequence 1 and five in Treatment Sequence 2, similarly distributed between epochs 1 and 2. In all participants and at all time points, plasma LOR concentrations were below the limit of quantification (0.100 ng/mL). Geometric mean concentrations and PK parameters for TCA were similar between treatment sequences.CONCLUSIONNo safety signals were observed. There were no quantifiable plasma concentrations of LOR in either Treatment Sequence. 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.TRIAL REGISTRATIONClinicalTrials.gov identifier, NCT04598542.

26 Nov 2023·Journal of Drug Targeting

Targeting WNT signalling pathways as new therapeutic strategies for osteoarthritis

Review

Author: Iqbal, Zoya ; Rehman, Khurrum ; Shabbir, Maryam ; Yujie, Liang ; Xia, Jiang ; Murtaza, Ghulam ; Duan, Li

Osteoarthritis (OA) is a highly prevalent chronic joint disease and the leading cause of disability. Currently, no drugs are available to control joint damage or ease the associated pain. The wingless-type (WNT) signalling pathway is vital in OA progression. Excessive activation of the WNT signalling pathway is pertinent to OA progression and severity. Therefore, agonists and antagonists of the WNT pathway are considered potential drug candidates for OA treatment. 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). Therefore, targeting the WNT signalling pathway may be a distinctive approach to developing particular agents helpful in treating OA. This review aims to update the most recent progress in OA drug development by targeting the WNT pathway. In this, we introduce WNT pathways and their crosstalk with other signalling pathways in OA development and highlight the role of the WNT signalling pathway as a key regulator in OA development. Several articles have reviewed the Wnt pathway from different aspects. 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 emphasise 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.

News (Medical) associated with Lorecivivint

12 Sep 2024

·www.globenewswire.com

Biosplice Therapeutics Announces Initiation of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Trial Sponsored by the National Cancer Institute (NCI)

Biosplice expands its clinical candidate, cirtuvivint, as standalone treatment and combination therapy in patients with AML and MDS, representing next step in ongoing collaboration with the NCISAN DIEGO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering advancements in small molecule inhibition of CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the NCI-sponsored Investigational New Drug (IND) application for cirtuvivint. This small molecule inhibitor of CLK and DYRK kinases is in development for the treatment of hematological malignancies and solid tumors. This clearance allows for the initiation of a new clinical trial of cirtuvivint, both as a standalone treatment for patients with relapsed/refractory AML and MDS as well as in combination with ASTX727 for patients with frontline high-risk MDS. The clinical study (NCI protocol 10674, NCT06484062) will be sponsored by the NCI, part of the National Institutes of Health, with Dr. Maximilian Stahl from the Dana-Farber Cancer Institute serving as principal investigator. This trial will be conducted in participating centers of the NCI’s Experimental Therapeutics Clinical Trials Network including Dana-Farber Cancer Institute and Memorial Sloan Kettering Cancer Center. The study aims to enroll up to 52 patients and will be conducted under the Cooperative Research and Development Agreement (CRADA) executed between Biosplice and the NCI. “We are thrilled that the NCI has received FDA clearance to launch this groundbreaking new Phase 1 trial of cirtuvivint in liquid tumors, both as monotherapy and in combination with ASTX727,” stated Dr. Yusuf Yazici, Chief Medical Officer of Biosplice. “This milestone is a major step forward in our efforts to advance innovative treatments targeting CLKs and DYRKs. Given that dysregulated alternative splicing is commonly implicated in AML and MDS, cirtuvivint’s ability to regulate alternative splicing via CLK and DYRK inhibition may provide a promising new therapeutic pathway for patients. Based on compelling anti-tumor activity across both solid and liquid tumors in in vitro and in vivo models, as well as data from two prior Phase 1 trials in solid tumors, cirtuvivint promises to greatly improve outcomes for patients in these critical and underserved areas.” This milestone highlights the ongoing collaboration between Biosplice and the NCI’s Cancer Therapy Evaluation Program (CTEP) through the NCI Experimental Therapeutics (NCI-NExT) program. After extensive evaluation, cirtuvivint was chosen for inclusion by NCI in the NExT programs following a competitive review. NCI-NExT partners with external researchers and leading scientific experts to accelerate the development of the most promising and innovative therapies, guiding them from early-stage research through to regulatory approval. About Biosplice:Biosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for osteoarthritis (completed Phase 3) and cirtuvivint for numerous cancers, with a broad preclinical pipeline that encompasses Alzheimer’s disease, diabetes and other degenerative conditions. About Cirtuvivint:Cirtuvivint is a small molecule inhibitor of CLK and DYRK kinases, which are increasingly recognized as key drivers of various cancers. By targeting these kinases, cirtuvivint modulates alternative pre-mRNA splicing, which may reduce the expression of genes vital for tumor growth, survival, and drug resistance. The compound has shown broad anti-tumor activity across a range of solid and liquid tumors in extensive preclinical studies. Cirtuvivint has also been investigated for the treatment of advanced solid tumors in two clinical trials. The first, SM08502-ONC-01 (NCT03355066), was a first-in-human dose escalation study designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors. The second, SM08502-ONC-03 (NCT05084859), was a Phase 1b trial assessing the efficacy of cirtuvivint in combination with standard treatments for patients with advanced castration-resistant prostate cancer, advanced non-small cell lung cancer, and advanced colorectal cancer. Learn more at https://www.biosplice.com

Phase 1INDPhase 3

13 Jun 2024

·www.biospace.com

Biosplice Announces Collaboration with Novo Nordisk in Diabetes

Biosplice to leverage leading position in small-molecule DYRK inhibition with Novo Nordisk in a pre-clinical collaboration to develop first-in-class therapies for diabetes. SAN DIEGO, June 13, 2024 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of DYRK/CLK kinases, has entered a collaboration with Novo Nordisk to develop drug candidates for the treatment of diabetes. This agreement builds upon Biosplice’s innovative research, supported by robust external scientific literature, demonstrating the potential of DYRK inhibition to stimulate β-cell proliferation in animal models and human islet cells, thus offering a promising avenue for diabetes treatment. The collaboration combines Novo Nordisk’s expertise in diabetes and Biosplice’s research and development efforts focused on creating selective and potent DYRK inhibitors. Under the terms of the agreement, Novo Nordisk will fund further preclinical development, with an exclusive option to license Biosplice’s relevant intellectual property primarily focused on cardiometabolic disorders. Specific financial terms were not disclosed, but would include upfront and milestone payments plus royalties for the exclusive license. “We are extremely pleased to combine our unique DYRK inhibition expertise with Novo Nordisk’s leadership in diabetes treatments,” commented Erich Horsley, CFO and CBO of Biosplice. “For over a decade, Biosplice has pioneered the therapeutic potential of highly selective, small-molecule inhibition of DYRK and CLK kinases. Representing over 500 million patients worldwide, diabetes sufferers stand to benefit enormously from developing therapies, such as ours, which hold the promise of restoring the health of human β-cells. We eagerly anticipate unlocking the immense possibilities through our collaboration with Novo Nordisk.” Biosplice management believes that its selective DYRK inhibitors, which have shown encouraging results in animal models and human islet cells, promise excellent potency and safety margins to enable a first-in-class therapy for diabetes treatment. Scientific literature suggests that DYRK kinases play a pivotal role in maintaining the proliferative capacity of β-cells, essential pancreatic cells responsible for producing insulin, a critical hormone regulating blood sugar. Diabetes patients grapple with insufficient insulin production due to a deficiency or dysfunction of pancreatic β-cells. This approach could potentially go beyond currently approved therapies to address the underlying cause of the disease. Biosplice will present publicly some of its preclinical findings from in vivo and in vitro models at the upcoming American Diabetes Association’s conference in Orlando, Florida on June 23 at 12:30 pm. The DYRK kinase has also been implicated as a key driver of harmful aggregation of tau protein, a potential driver of serious neurological conditions. Biosplice has recently announced a collaboration with The Roskamp Institute for traumatic brain injury and is developing lead candidates for the treatment of various tauopathies and neuroinflammatory conditions, including Alzheimer’s disease, frontal temporal dementia and multiple sclerosis. About Biosplice’s Diabetes Program: Biosplice pioneers the development of highly selective and potent DYRK inhibitors to stimulate insulin-secreting β-cell proliferation, a crucial advancement in diabetes treatment. Targeting DYRK holds immense potential in enhancing pancreatic islet function and refining glucose regulation, addressing a key shortfall in both type 1 and type 2 diabetes management. Biosplice's compounds have shown promising results in animal models and human islet cells, amplifying β-cell regeneration and offering renewed hope for effective diabetes therapies. About Biosplice Biosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for osteoarthritis and cirtuvivint for numerous cancers, with a broad pre-clinical pipeline that encompasses Alzheimer’s disease, diabetes and other degenerative conditions. Learn more at Corporate Contact: Erich Horsley erich.horsley@biosplice.com

License out/in

18 Apr 2024

·www.biospace.com

Biosplice Announces Upcoming Presentation of Successful OA-07 Phase 3 Long-Term Structure and Pain & Function Results for Lorecivivint for Treatment of Knee Osteoarthritis at OARSI Conference, and...

Biosplice Announces Upcoming Presentation of Successful OA-07 Phase 3 Long-Term Structure and Pain & Function Results for Lorecivivint for Treatment of Knee Osteoarthritis at OARSI Conference, and Completion and Preliminary Analysis of OA-21 Trial 12-Week Pain Results Final analysis of OA-07 results demonstrated statistically significant improvement in joint structure, WOMAC Pain and WOMAC Function, highlighting potential of lorecivivint to be first-in-class, structure-modifying drug for treatment of knee osteoarthritis (OA). Preliminary analysis of OA-21 short-term pain results did not achieve statistical significance SAN DIEGO, April 18, 2024 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of CLK/DYRK kinases, recently completed two Phase 3 trials, OA-07 long-term structure, pain and function study, and OA-21 short-term pain study. Preliminary results of OA-07 study, initially reported in November 2023, had demonstrated statistically significant and clinically meaningful improvement in joint structure demonstrated by X-ray results of medial joint space width (medial JSW). Final analysis of OA-07 results confirmed this structural benefit and further demonstrated that patients also experienced statistically significant reduction in their pain (as measured by WOMAC Pain at Month 6 and Month 12) and significant improvement in function (as measured by WOMAC Function at Month 12). Biosplice will present its OA-07 results at the Osteoarthritis Research Society International (“OARSI”) World Congress, April 18-21, 2024, in Vienna, Austria. “Patients are desperately seeking a new and safe approach for treating knee osteoarthritis that can provide durable pain relief, improved function, and joint structure benefit,” commented Biosplice Chief Medical Officer, Dr. Yusuf Yazici. “We are very encouraged by our unique data from our OA development program, and especially the recent OA-07 trial, and look forward to sharing these results with the medical community in upcoming meetings.” With respect to the shorter-term OA-21 study, preliminary analysis showed that the study did not meet the primary endpoint of pain reduction at Week 12. The Company observed an unusually high placebo response in this trial compared to published intra-articular OA trials and Biosplice’s prior trials. The Company is currently analyzing these preliminary OA-21 results to further discern what may have caused this result in contrast with the successful OA-07 results, as well as the successful short- and long-term pain and function results of the OA-04 Phase 2 study. The primary goal of Biosplice OA program has been to develop a first-in-class drug that could provide the more than 30 million OA patients in the US, and many more worldwide, with an effective treatment option that would go beyond mere short term pain relief. The cumulative data from Biosplice’s OA program to date, especially in light of the final results of the OA-07 Phase 3 X-ray study, provide strong support in service of this goal. OA-07 study results show that lorecivivint (1) provided a structural benefit in a statistically significant and clinically meaningful manner in moderate and advanced OA patients, a first-in-class attribute among OA treatment options, (2) reduced patients’ pain, (3) improved their function with (4) a remarkably clean safety pro date. With the benefit of these clinical results, Biosplice intends to consult with the US Food and Drug Administration (FDA), as well as regulatory agencies in other countries, for further guidance on the path to marketing approval of lorecivivint. About Biosplice Biosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for osteoarthritis and cirtuvivint for numerous cancers, with a broad pre-clinical pipeline that encompasses Alzheimer’s disease, diabetes and other degenerative conditions. Learn more at Corporate Contact: Erich Horsley erich.horsley@biosplice.com

Clinical ResultPhase 3Phase 2

100 Deals associated with Lorecivivint

External Link

KEGG	Wiki	ATC	Drug Bank
D11588	-	-	DB14883

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 3	US	SAMIL PHARMACEUTICAL Co., Ltd.	-
Osteoarthritis, Hip	Preclinical	US	Biosplice Therapeutics, Inc.	17 Jul 2023
Shoulder arthritis	Preclinical	US	Biosplice Therapeutics, Inc.	17 Jul 2023
Intervertebral Disc Degeneration	Discovery	US	Biosplice Therapeutics, Inc.	26 Jul 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04520607 (OA-07, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	pnhgnddgzh(uzlhdlxhrt) = jphtuzoicn hqkixziwns (vbkwqhymxd, 0.05)	Positive	14 Jun 2024
				Placebo	pnhgnddgzh(uzlhdlxhrt) = sfqlgoycmb hqkixziwns (vbkwqhymxd, 0.05)
NCT04520607 (OA-07, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	drqbdxmcer(imiesqocyw) = cckfworcmx ykbvtodvwb (afgbrinqjd, 2.0) View more	Positive	14 Jun 2024
				Placebo	drqbdxmcer(imiesqocyw) = iklnvzfxte ykbvtodvwb (afgbrinqjd, 2.1) View more
NCT03928184 (OA-07, WCO_IOF_ESCEO2024)	Phase 3	Osteoarthritis, Knee	276	Lorecivivint 0.07 mg	genhltbxpy(ualasupvgd) = weuveikuud wsnirlhoqp (brqlwkdgxw, 0.05)	Positive	11 Apr 2024
				Placebo	genhltbxpy(ualasupvgd) = skjsfzludo wsnirlhoqp (brqlwkdgxw, 0.05)
NCT03928184 \| NCT04520607 (OA-07, GlobeNewswire) Manual	Phase 3	Osteoarthritis, Knee	-	Lorecivivint	(pgjnfmqsmr) = lorecivivint continued to appear safe and well-tolerated, with no additional safety signals with repeat injections. hlqggbjzlc (tsbyqixkdq ) View more	Positive	13 Nov 2023
				placebo
EULAR2023	Phase 2/3	Osteoarthritis, Knee	-	Lorecivivint 0.07mg	otwlqjfwya(jznjnhvzej) = gofmboixoc ppoizntjvs (ueswcgfygz )	-	31 May 2023
				Placebo	otwlqjfwya(jznjnhvzej) = pbokcgddqv ppoizntjvs (ueswcgfygz )
NCT04520607 (OA-07, EULAR2023)	Phase 3	Osteoarthritis, Knee	277	Lorecivivint	jvlpnbxrnm(qsyisohzsw) = Average change from extension baseline to 24 months in Pain NRS was -0.25 (± 0.19) for LOR (n=121) compared to 0.09 (± 0.19) for placebo (n=130) (Δ=-0.34, 95% CI [-0.87, 0.19], P =0.207). Similar trends were seen for LOR treatment effect over PBO at 24 months for WOMAC Function Δ=-4.90 (95% CI [-9.92, 0.13], P =0.056) and WOMAC Pain Δ=-5.18 (95% CI [-10.28, -0.08], P =0.047). At 36 months, open-label IA injection of LOR (n=35) showed additional Pain NRS improvements with change from OA-07 baseline of -0.91 (±0.34) and cross-over participants from PBO to LOR (n=45) showed improvement of -0.43 (±0.30). Good concordance was shown between change in medial JSW and at least a 20% improvement in Pain NRS at 36 months (n=20, AUC=0.719) rqptvaoewk (tpycdnozwz ) View more	Positive	31 May 2023
				Placebo
LORECIVIVINT (WCO_IOF_ESCEO2023)	Phase 2/3	Osteoarthritis, Knee	-	Lorecivivint	bizkpuiazw(crrzgyqdcu) = myadmhsurz ppphioxxon (wlartaixwk )	-	04 May 2023
				Placebo	bizkpuiazw(crrzgyqdcu) = yzxvwqqsnh ppphioxxon (wlartaixwk )
NCT04520607 (OA-07, WCO_IOF_ESCEO2023)	Phase 3	Osteoarthritis, Knee	277	Lorecivivint	jrsvnyifdv(kbitacorun) = zyvamsovbg ywaquszihy (lpujtdcrip, 0.69)	Positive	04 May 2023
NCT04520607 (OA-07, WCO_IOF_ESCEO2023)	Phase 3	Osteoarthritis, Knee	277	Lorecivivint	vamsnqbdwg(tklzdlidrd) = mwjzebggrp utmlwhxcpf (hoptvbhfyp )	Positive	04 May 2023
ACR2022	Not Applicable	Osteoarthritis, Knee	-	Lorecivivint 0.07 mg	cdekomciit(npdhhmiunr) = drgqssznax iobgablpez (rcuepwzknn ) View more	-	14 Nov 2022
				Lorecivivint 0.23 mg	cdekomciit(npdhhmiunr) = aeqpwfhaab iobgablpez (rcuepwzknn ) View more

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