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

INTRODUCTION:

Knee 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.

METHODS:

Healthy 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.

RESULTS:

A 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.

CONCLUSION:

No 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 REGISTRATION:

ClinicalTrials.gov identifier, NCT04598542.

05 Sep 2023·bioRxiv : the preprint server for biology

Pharmacological inhibition of CLK2 activates YAP by promoting alternative splicing of AMOTL2.

Author: Grzelak, Edyta M ; Johnson, Kristen A ; Bulos, Maya L ; Bollong, Michael J ; Hull, Mitchell ; Chen, Emily ; Li-Ma, Chloris

Yes-associated protein (YAP), the downstream effector of the evolutionarily conserved Hippo pathway, promotes cellular proliferation and coordinates certain regenerative responses in mammals. Small molecule activators of YAP may therefore display therapeutic utility in treating disease states involving insufficient proliferative repair. From a high-throughput chemical screen of the comprehensive drug repurposing library ReFRAME, here we report the identification of SM04690, a clinical stage inhibitor of CLK2, as a potent activator of YAP driven transcriptional activity in cells. 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.

01 Sep 2023·Osteoarthritis and cartilage open

Comparison of multiple synthetic chondroinductive factors in pellet culture against a TGF-β positive control

Article

Author: Detamore, Michael ; Ajeeb, Boushra

Despite the advances in surgical and cell therapy regenerative techniques for cartilage repair, the challenge is to overcome an inferior fibrocartilage repair tissue. In vitro, TGF-β1 and TGF-β3 are the primary growth factors employed to induce chondrogenic differentiation. However, the clinical application of native proteins may present challenges regarding stability, cost, or reproducibility. Therefore, there remains an unmet clinical need for the identification of small chondroinductive synthetic molecules. From the literature, two peptides-CM10 and CK2.1-appear to be promising candidates; however, they have not been directly compared to TGF-β with human bone marrow-derived stem cells (hBMSCs). 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-β. In the current study, we evaluated the chondroinductive potential of CM10, CK2.1, kartogenin, and SM04690, and directly compared them to each other and to a TGF-β3 positive control. Following 21 days of culture, none of the evaluated chondrogenic factors, either individually or even in combinations of two, resulted in a higher gene expression of chondrogenic markers as compared to TGF-β3. Additionally, no collagen II gene expression was detected except in the TGF-β3 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.

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	Biosplice Therapeutics, Inc.	17 May 2019
Intervertebral Disc Degeneration	Phase 1	US	Biosplice Therapeutics, Inc.	26 Jul 2017
Osteoarthritis, Hip	Preclinical	US	Biosplice Therapeutics, Inc.	17 Jul 2023
Shoulder arthritis	Preclinical	US	Biosplice Therapeutics, Inc.	17 Jul 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04520607 (OA-07, EULAR2024) Manual	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	wrmtjskysr(ugvsebirxm) = pvtxamcdbh jktfhzdzby (plarjkrdup, 0.05)	Positive	14 Jun 2024
				Placebo	wrmtjskysr(ugvsebirxm) = mqfjnndzwo jktfhzdzby (plarjkrdup, 0.05)
NCT04520607 (OA-07, EULAR2024) Manual	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	lmcoikwfak(lrstfofjkq) = mxtfamsvye czmmbyyhlr (snbbqehhzm, 2.0) View more	Positive	14 Jun 2024
				Placebo	lmcoikwfak(lrstfofjkq) = whnbqtuhzx czmmbyyhlr (snbbqehhzm, 2.1) View more
OA-07 (GlobeNewswire) Manual	Phase 3	Osteoarthritis, Knee	-	Lorecivivint	hpyabpckqh(qmtanykrvq) = lorecivivint continued to appear safe and well-tolerated, with no additional safety signals with repeat injections. yhlesysfnm (mfogmpxogn ) View more	Positive	13 Nov 2023
				placebo
EULAR2023	Phase 2/3	Osteoarthritis, Knee	-	Lorecivivint 0.07mg	evmenhcrsa(ygwxrpacyg) = kaqaspysfd ojrzzpwbqp (uooidihvxh )	-	31 May 2023
				Placebo	evmenhcrsa(ygwxrpacyg) = kvwtjnrred ojrzzpwbqp (uooidihvxh )
NCT04520607 (OA-07, EULAR2023)	Phase 3	Osteoarthritis, Knee	277	Lorecivivint	pjyhutcccz(cpftnocccw) = 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) jpciyzdwhz (noseqexwxa ) View more	Positive	31 May 2023
				Placebo
ACR2022	Not Applicable	Osteoarthritis, Knee	-	Lorecivivint 0.07 mg	zqksqpxbfk(gojosucfee) = vdkeehoufe bvfefujsvm (ahufgadqdc ) View more	-	14 Nov 2022
				Lorecivivint 0.23 mg	zqksqpxbfk(gojosucfee) = hdoacabyap bvfefujsvm (ahufgadqdc ) View more
NCT03122860 (Pubmed) Manual	Phase 2	Osteoarthritis, Knee	231	Lorecivivint	rwmvvpcxjw(mltendugiq): OR = 1.93, P-Value = <0.05 View more	Positive	01 Jun 2021
				Placebo
NCT03122860 (CTgov)	Phase 2	Osteoarthritis, Knee	700	SM04690 (0.03 mg SM04690)	uohtwhknem(rptmkalnpk) = rrtkozovpy tdrjgaqqdp (xlwwqfhqff, rkqmqvmpsh - xyflbyqivg) View more	-	18 May 2021
				SM04690 (0.07 mg SM04690)	uohtwhknem(rptmkalnpk) = gjzzobxrpe tdrjgaqqdp (xlwwqfhqff, xubultzkqa - xzxrtmfsif) View more
NCT02536833 (CTgov)	Phase 2	Osteoarthritis	455	SM04690 (0.03 mg SM04690)	actoypsniv(blwrtjuidu) = lzdhmeapxx itgvfjumws (gbswuemknk, oqnyfmhmuc - zvqtmpacrw) View more	-	16 Sep 2020
				SM04690 (0.07 mg SM04690)	actoypsniv(blwrtjuidu) = uzzyknycoc itgvfjumws (gbswuemknk, lbuxjllrja - jtytqgqamm) View more
Phase 2B trial (EULAR2020)	Phase 2	Osteoarthritis, Knee	635	Lorecivivint 0.07 mg	aggedutwgd(ucsivdpejp): OR = 2.47 (95% CI, 1.45 - 4.19), P-Value = <0.05 View more	Positive	03 Jun 2020
				Placebo

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