Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1129 |
| INN | Tulisokibart |
| Status | Clinical |
| Drug code(s) | PRA023, MK-7240 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | TL1a |
| Indications of clinical studies | Systemic Sclerosis Associated With Interstitial Lung Disease, Crohn’s disease, Ulcerative colitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 14, 2020 |
| Start of Phase 2 | July 14, 2021 |
| Start of Phase 3 | October 15, 2023 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Merck Sharp & Dohme LLC |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06651281 Phase 3 extension study in Crohn's and UC due to start in Dec 2024. NCT06430801 Phase 3 in Crohn's Disease started in June 2024. NCT06052059 Phase 3 in ulcerative colitis started in Oct 2023. June 2023: Prometheus acquired by Merck Dec 2022: Prometheus’ Phase 2 ARTEMIS-UC clinical trial was a 12-week, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of PRA023 in patients with moderate-to-severely active UC who have failed conventional or advanced therapy. PRA023 met the primary and all ranked secondary endpoints including clinical, endoscopic, histologic, and patient-reported outcome measures in the initial cohort (Cohort 1) of the trial. Prometheus intends to advance PRA023 into Phase 3 studies for UC and CD in 2023 NCT05013905 Phase 2 in Crohn's disease started in July 2021. July 19, 2021 I Prometheus Biosciences, Inc. announced the initiation of the Phase 2 ARTEMIS-UC clinical trial (NCT04996797) evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment. NCT04676178 Phase 1 in healthy volunteers December 15, 2020: Prometheus Biosciences, Inc. announced FDA acceptance of its Investigational New Drug Application (IND) for PRA023 and that dosing has commenced in a Phase 1a clinical study in normal healthy volunteers. Prometheus is developing PRA023 for the two most common forms of IBD, ulcerative colitis (UC) and Crohn’s disease (CD). |
| Full address of company | Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/ |
PRA023 is an IgG1 humanized mAb that has been shown to block TL1A. Third-party antibody programs against TL1A have been shown to reduce both intestinal inflammation and fibrosis in preclinical studies, and this target has been clinically-validated in a third-party Phase 2a clinical trial in UC. PRA023 binds both soluble and membrane-associated human TL1A with high affinity and specificity and has the potential to substantially improve outcomes for moderate-to-severe IBD patients. Target is vascular endothelial growth inhibitor (VEGI), also known as TNF-like ligand 1A (TL1A) and TNF superfamily member 15 (TNFSF15)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |