Tulisokibart Clinical Naked monospecific

Antibody Information

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

Therapeutic information

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

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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 information

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/

Description/comment

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)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None