Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Start Date25 Nov 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

CTIS2023-508636-61-00

/ RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease - MK-7240-008

Start Date06 Nov 2024

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

CTR20242056

/ RecruitingPhase 3

一项在中度至重度活动性克罗恩病受试者中评价Tulisokibart的有效性和安全性的III期、随机、双盲、安慰剂对照研究

[Translation] A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Tulisokibart in subjects with moderately to severely active Crohn's disease

研究1：根据第12周和第52周时达到临床缓解以及达到内镜应答的受试者比例，评价MK-7240与安慰剂相比的有效性。评价MK-7240的安全性和耐受性。研究2：根据第12周时达到临床缓解以及达到内镜应答的受试者比例，评价MK-7240与安慰剂相比的有效性。评价MK-7240的安全性和耐受性。

[Translation]

Study 1: To evaluate the effectiveness of MK-7240 compared to placebo based on the proportion of subjects achieving clinical remission and endoscopic response at Week 12 and Week 52. To evaluate the safety and tolerability of MK-7240. Study 2: To evaluate the effectiveness of MK-7240 compared to placebo based on the proportion of subjects achieving clinical remission and endoscopic response at Week 12. To evaluate the safety and tolerability of MK-7240.

Start Date08 Oct 2024

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

[+2]

100 Clinical Results associated with Tulisokibart

100 Translational Medicine associated with Tulisokibart

100 Patents (Medical) associated with Tulisokibart

Literatures (Medical) associated with Tulisokibart

01 Mar 2025·Revue medicale de Liege

[Intestinal fibrosis in Crohn's disease : towards new therapeutic options?]

Review

Author: Vieujean, Sophie ; Stepniak, Marty ; Louis, Édouard ; Meuwis, Marie-Alice ; Bequet, Émeline

Crohn's disease is a chronic inflammatory bowel disease that can lead to fibrostenotic complications. These strictures result from an imbalance between inflammation and excessive healing, leading to an abnormal accumulation of extracellular matrix and a progressive thickening of the intestinal wall. To date, no specific treatment is available to prevent or reverse intestinal fibrosis. The management of strictures primarily focuses on controlling inflammation and addressing obstructive complications through endoscopic balloon dilation, stricturoplasty, or intestinal resection. Current medical therapies, such as anti-TNF agents, can help reduce inflammation but have no direct impact on fibrosis. New therapeutic strategies are emerging, including TL1A inhibitors (duvakitug, tulisokibart), an ALK5 inhibitor (AGMB-129), and targeted AGR2 therapies (TH-009). Additionally, mesenchymal stem cells are being investigated in our hospital center in combination with endoscopic balloon dilation, aiming to assess their therapeutic potential. The development of effective anti-fibrotic therapies remains a critical medical need to improve the management of intestinal strictures and reduce the need for invasive procedures in Crohn's disease.

26 Sep 2024·NEW ENGLAND JOURNAL OF MEDICINE

Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis

Article

Author: Luo, Allison ; Ritter, Timothy E ; Ma, Christopher ; Leszczyszyn, Jaroslaw ; Feagan, Brian G ; Sands, Bruce E ; Lu, Jiandong ; Yen, Mark ; Targan, Stephan ; Nguyen, Deanna D ; Laurent, Olivier ; McGovern, Dermot P B ; Danese, Silvio ; Peyrin-Biroulet, Laurent ; Kempiński, Radosław ; Rubin, David T

BACKGROUND:

Tulisokibart is a tumor necrosis factor-like cytokine 1A (TL1A) monoclonal antibody in development for the treatment of moderately to severely active ulcerative colitis. A genetic-based diagnostic test was designed to identify patients with an increased likelihood of response.

METHODS:

We randomly assigned patients with glucocorticoid dependence or failure of conventional or advanced therapies for ulcerative colitis to receive intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo. Cohort 1 included patients regardless of status with respect to the test for likelihood of response. Cohort 2 included only patients with a positive test for likelihood of response. The primary analysis was performed in cohort 1; the primary end point was clinical remission at week 12. Patients with a positive test for likelihood of response from cohorts 1 and 2 were combined in prespecified analyses.

RESULTS:

In cohort 1, a total of 135 patients underwent randomization. A significantly higher percentage of patients who received tulisokibart had clinical remission than those who received placebo (26% vs. 1%; difference, 25 percentage points; 95% confidence interval [CI], 14 to 37; P<0.001). In cohort 2, a total of 43 patients underwent randomization. A total of 75 patients with a positive test for likelihood of response underwent randomization across both cohorts. Among patients with a positive test for likelihood of response (cohorts 1 and 2 combined), clinical remission occurred in a higher percentage of patients who received tulisokibart than in those who received placebo (32% vs. 11%; difference, 21 percentage points; 95% CI, 2 to 38; P = 0.02). Among all the enrolled patients, the incidence of adverse events was similar in the tulisokibart and placebo groups; most adverse events were mild to moderate in severity.

CONCLUSIONS:

In this short-term trial, tulisokibart was more effective than placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis. (Funded by Prometheus Biosciences, a subsidiary of Merck; ARTEMIS-UC ClinicalTrials.gov number, NCT04996797.).

01 Jan 2024·Advances in pharmacology (San Diego, Calif.)

TL1A: A model for a precision medicine approach in the treatment of Crohn’s disease and ulcerative colitis

Review

Author: Bilsborough, Janine M ; Targan, Stephan R. ; Targan, Stephan R ; Bilsborough, Janine M.

Inflammatory bowel disease (IBD) is a collective term for chronic inflammatory diseases of the intestinal tract. The term IBD encompasses two main forms, Crohn's disease (CD) and Ulcerative colitis (UC). CD is characterized by inflammation throughout the length of the gut, especially the ileum and colon, and is often complicated with fistulae and/or intestinal strictures. Ulcerative colitis (UC) is inflammatory disease restricted to the colon and rectum. In practice however, IBD is a heterogenous disease with CD and UC representing the extremes of a continuum of diseases with varied clinical presentation, including disease location, severity, and manifestation of extraintestinal diseases. This disease heterogeneity poses a challenge to successful and efficacious therapeutic treatment as the etiology driving disease in individual patients is unknown and likely to be multifactorial, including genetic predisposition, environmental factors such as the microbiota, as well as social behaviors such as smoking and diet. Precision medicine provides a strategy to account for disease heterogeneity and diverse etiology to select for patients most likely to respond to a given therapeutic. In this chapter we present an example of the development of a novel antibody therapeutic, Tulisokibart, as a model for a Precision Medicine approach to the successful treatment of patients with IBD.

News (Medical) associated with Tulisokibart

20 Mar 2025

·endpts.com

Updated: Monte Rosa reports first data for molecular glue program licensed to Novartis

Monte Rosa Therapeutics reported Phase 1 data Thursday morning for a Novartis-partnered program that the companies believe could change the treatment paradigm for some immune-mediated diseases. Though the data come from healthy volunteers, observers are keen to see whether the program known as MRT-6160 can affect certain immunological biomarkers while remaining safe. Other drug classes targeting the immune system, particularly JAK and interleukin inhibitors, can sometimes cause taxing side effects for patients. In the Phase 1 study, researchers tested MRT-6160 in 70 individuals across five single-ascending doses and three multiple-ascending doses. The program degraded a protein called VAV1 by greater than 90% in individuals’ peripheral T cells in all but the lowest dose cohorts, according to SEC documents. The results were also dose-dependent. Monte Rosa also measured VAV1 degradation in peripheral B cells, with MRT-6160 inducing “similar” results to the T cell data — although the company did not report specific figures. On an investor call Thursday morning, Monte Rosa executives were asked how the results might translate to patients, given that the Phase 1 came from ex vivo stimulation of healthy volunteers’ blood cells. CEO Markus Warmuth said it would depend on the disease but the company is confident in how MRT-6160 hit its biomarkers. Following the Phase 1 trials, Novartis is expected to take over development and decide which diseases to test Phase 2. Preparation for Phase 2 studies is ongoing. Warmuth said the final decision on which diseases to test MRT-6160 in Phase 2 has not been made, but hinted at where Monte Rosa and Novartis see the most potential. “We had a very strong preclinical data in [ulcerative colitis], very interesting data in rheumatoid arthritis,” Warmuth said. “There’s related diseases you could think about.” MRT-6160 is designed to target VAV1, which works downstream of T cell and B cell receptors, according to Monte Rosa. The idea is to reduce cytokine proteins that fuel autoimmune conditions when modulated. The data also provide an early snapshot into the potential of molecular glues. The space has grown significantly in the last 18 months, with at least 10 licensing deals signed between biotech and pharma partners. Novartis paid Monte Rosa $150 million upfront for full rights to MRT-6160 in the largest upfront payment for a molecular glue deal in that time frame . Jefferies analyst Kelly Shi previewed the data in a Sunday note, saying the expectation heading into Thursday was VAV1 degradation of about 80%, as well as reducing certain biomarker expression by at least 70%. Such a profile, Shi wrote, could “support its early potential” in both rheumatoid arthritis and inflammatory bowel disease. The four main biomarkers Shi highlighted were CD69, IL-2, IL-6, and IL-17, with the latter three implicated in AbbVie’s JAK inhibitor Rinvoq. IL-17 in particular plays an important role in ulcerative colitis. Another experimental drug, Merck and Prometheus’ anti-TL1A program MK-7240, showed a 50% reduction in IL-17 for IBD patients in a Phase 2 study. Results from the trial showed that in CD69, MRT-6160 suppressed regulation by greater than 90% in certain doses, Monte Rosa said. The program also inhibited IL-2, IFN-γ and IL-17A “by up to 99%.” IL-6 levels were between 60% and 90%. Safety data indicated all side effects were mild or moderate. Monte Rosa’s stock price $GLUE was volatile premarket, going up about 6% and then falling as much as 16% Thursday morning. After the market opened, shares were up about 8%. Separately, Monte Rosa released new Phase 2 data for an oncology program called MRT-2359, which it is developing in-house. This molecular glue aims to degrade the GSPT1 protein in the hopes of improving outcomes for cancer patients with tumors driven by what are known as MYC transcription factors. So far, researchers tested the program in 59 patients with MYC-related malignancies. They found that, among 37 evaluable patients, MRT-2359 induced one partial response in a patient with MYC biomarkers. There was also one unconfirmed partial response in an individual who was biomarker negative. Monte Rosa is opting to deprioritize most indications. Warmuth noted on the call that the partial response occurred in a patient with neuroendocrine bladder cancer. The patient had “extremely high expression” of MYC biomarkers. The lead indication for MRT-2359 will now be castration-resistant prostate cancer, and all lung cancer work will be shelved. Monte Rosa will still enroll patients with HR+ breast cancer. Additional data will be available for both prostate and breast cancer in the second half of the year. Monte Rosa does not yet have data from prostate cancer patients, Warmuth said, because it hasn’t received clear biopsies. When the company reports data later this year, Warmuth said he hopes there will be results from 20 to 30 prostate cancer patients. Monte Rosa also reported its full-year and fourth-quarter earnings Thursday morning, saying its cash runway will extend into 2028. Editor’s note: This article was updated to include additional information from Monte Rosa’s investor call on Thursday morning.

Phase 1Clinical ResultPhase 2

24 Feb 2025

·endpts.com

Sanofi, Teva bolster case for IBD drug with Phase 2 data, despite potential competition

Sanofi and Teva’s inflammatory bowel disease candidate could make €1 billion ($1.05 billion) a year by 2032, Leerink analysts said on Sunday. The blockbuster projection comes after the partners shared updated Phase 2b data from the anti-TL1A drug, dubbed duvakitug. The trial had a positive topline readout in December, earlier than was anticipated. But the new results, which were shared in a Saturday release , show “further evidence of efficacy and safety across all predefined subgroups,” the Leerink analysts said. Duvakitug produced responses in IBD patients who had previously been treated with advanced therapies (ATs) such as biologics, as well as those who hadn’t. In particular, 36% of AT-experienced ulcerative colitis patients who got the 900 mg dose achieved clinical remission, representing a 29% improvement over placebo. Just over half the AT-naïve patients also hit remission at that dose, yielding a 26% difference from placebo. In the Crohn’s disease cohort, 48% of AT-experienced patients given the 900 mg dose had an endoscopic response, representing a 44% improvement over placebo. Endoscopic responses were measured via the Simple Endoscopic Score for Crohn’s Disease, which considers ulcer size and surface area, among other factors. Clinical remission was measured per the modified Mayo Score, which looks at symptoms like stool frequency and rectal bleeding. The endoscopic response rate was 47% for AT-naïve patients on the same dose, good for a 25% difference from placebo. Sanofi and Teva plan to start a Phase 3 trial later this year. The French drugmaker spent €469 million ($500 million) upfront to license duvakitug from Teva back in October 2023. Teva could get up to $1 billion in milestones, split across $600 million for Phase 3 initiations and $400 million for launches. Sanofi will be responsible for commercialization in most markets, including the US, while Teva will lead in Europe, Israel and certain other countries. But the sell-side’s blockbuster forecasts should perhaps be taken with a grain of salt. Two other anti-TL1A drugs are ahead of duvakitug in the clinic and they offer less frequent dosing regimens — once every four weeks versus once every two weeks. These are Roche’s RVT-3101 ( acquired from Roivant) and Merck’s MK-7240, which it bought from Prometheus Biosciences in a deal worth $10.8 billion . Both drugs are already in Phase 3 development. Editor’s Note: This article was updated to clarify that RVT-3101 now belongs to Roche.

Clinical ResultPhase 3Phase 2Acquisition

17 Dec 2024

·endpts.com

Teva and Sanofi step on the gas with anti-TL1A in IBD

Teva and Sanofi announced positive mid-stage results ahead of schedule for their inflammatory bowel disease candidate as they look to keep pace in an anti-TL1A race with Merck and Roche. The duo’s duvakitug met the primary endpoints in a Phase 2b trial evaluating patients with ulcerative colitis and Crohn’s disease, two forms of IBD, Teva and Sanofi said Tuesday morning. In ulcerative colitis, 36.2% of patients taking a low dose of duvakitug and 47.8% of patients taking a high dose achieved clinical remission, compared to 20.45% of placebo patients at week 14. P-values came in at 0.05 and 0.003 for the low and high doses, respectively. In Crohn’s disease, 26.1% of low-dose duvakitug patients and 47.8% of high-dose patients saw an endoscopic response as measured by a scoring system for Crohn’s severity, compared to 13% on placebo (p-values were 0.058 for the low dose and <0.001 for the high dose). While 0.05 is typically considered the gold standard for assessing statistical significance, a Teva spokesperson said the Phase 2 study had a “one-sided test at a significance of 0.1.” The partners said duvakitug was “generally well-tolerated,” with similar rates of treatment-emergent adverse events occurring in the treatment and placebo arms. Sanofi put down €469 million ($500 million) upfront in a deal to co-develop and co-commercialize duvakitug with Teva in October 2023. The anti-TL1A contest also includes Roche, which put down $7.1 billion upfront in late 2023 to acquire Roivant’s subsidiary Telavant and RVT-3101. Merck is also a rival, following its acquisition of Prometheus Biosciences and its MK-7240 in a deal worth $10.8 billion. The duvakitug topline results came earlier than expected, due to “significant acceleration in patient recruitment,” Sanofi and Teva said back in July. As a result, they skipped an interim analysis which was originally planned for the second half of this year. Now, the partners said they plan to initiate a Phase 3 trial in 2025 in IBD “pending regulatory discussions.” A Teva spokesperson declined to share further specifics on the timing of Phase 3 initiation or the dose that will be taken forward. Each company will share the development costs globally, while Sanofi will lead Phase 3 development. Teva will lead commercialization in Europe, Israel and certain other countries, and Sanofi will take the commercial lead in North America, Japan and other parts of Asia, and the rest of the world. Editor’s Note: A correction has been made to reflect that Teva and Sanofi are studying duvakitug in inflammatory bowel disease, not irritable bowel disease.

Phase 2Clinical ResultAcquisitionPhase 3

100 Deals associated with Tulisokibart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Phase 3	United States	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	China	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Japan	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Australia	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Austria	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Belgium	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Canada	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Chile	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Colombia	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Croatia	Merck Sharp & Dohme LLC	05 Jun 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Colitis, Ulcerative	-	Tulisokibart 100 mg	vnfmwjixrh(ekclvpafph) = Through week 50, AEs occurred in 63% and 77% of patients receiving tulisokibart 250 mg and 100 mg, respectively; most were mild to moderate in severity. Serious AEs occurred in 1 patient (3%) and two patients (7%) in the tulisokibart 250 mg and 100 mg groups, respectively. vbchlrxand (mbkmahjrtj )	-	13 Oct 2024
				Tulisokibart 250 mg
NCT04996797 (ARTEMIS-UC, Pubmed \| N Engl J Med) Manual	Phase 2	Colitis, Ulcerative	135	Tulisokibart	adiuhuqgoa(viwvzccpze) = xqhpzopujz fnpdhhfvmj (pshnjoiuia )	Positive	26 Sep 2024
				Placebo	adiuhuqgoa(viwvzccpze) = abjyqlyswc fnpdhhfvmj (pshnjoiuia )
NCT04996797 (ARTEMIS-UC, CTgov)	Phase 2	Colitis, Ulcerative	178	Tulisokibart (Cohort 1 Tulisokibart)	uqkmcepdst = henawbzxso awydygcgng (jlirwujjzc, mglcqngvcw - gqefrwqtfk) View more	-	27 Jun 2024
				Placebo (Cohort 1 Placebo)	uqkmcepdst = piuglbmzkr awydygcgng (jlirwujjzc, tsmnknhnjv - ntxcyvawtt) View more
NCT05013905 (APOLLO-CD, CTgov)	Phase 2	Crohn Disease	55	Companion diagnostic (CDx)+PRA023 IV	qvbjbzrwae = uvdiymslqs ueezdiaeej (wftqhdammd, hfqebioccn - oferscsajz) View more	-	01 Nov 2023
NCT04996797 (ARTEMIS-UC, UEGW2023)	Phase 2	Ulcerative colitis, active moderate eosinophils \| neutrophils	135	PRA023	njeupkmwuc(vrbzpmocny) = jzhucpoult ryfzhhfurg (tuyavsqbpz ) View more	Positive	15 Oct 2023
				Placebo	njeupkmwuc(vrbzpmocny) = omzhefxlpv ryfzhhfurg (tuyavsqbpz ) View more
UEGW2023	Not Applicable	Ulcerative colitis, active moderate	-	PRA023	tqnxvtkdff(mgrcybmzuu) = kwlczhbumo wnbrmyxjgu (vlqzgjhqfn, 34.85) View more	-	15 Oct 2023
				Placebo	tqnxvtkdff(mgrcybmzuu) = txqvqicrdb wnbrmyxjgu (vlqzgjhqfn, 37.59) View more
ARTEMIS-UC \| COHORT 1 (UEGW2023)	Phase 2	Ulcerative colitis, active moderate TL1A	135	PRA023	cedzfreymg(zakfjgiilq) = dcoxaygitm yrxsrkflyn (ovxopdnvbv ) View more	Positive	15 Oct 2023
				Placebo	cedzfreymg(zakfjgiilq) = jarycgxzyo yrxsrkflyn (ovxopdnvbv ) View more

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