INCB000262 / Incyte - LARVOL DELTA

CALM-CSU: Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=113 | Terminated | Sponsor: Escient Pharmaceuticals, Inc | Trial completion date: Jul 2025 ➔ Jan 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Dec 2024; Strategic Business Decision

Trial completion date • Trial primary completion date • Trial termination • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

EP-262-104: An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Escient Pharmaceuticals, Inc | Active, not recruiting ➔ Completed

Trial completion

CALM-CIndU: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Escient Pharmaceuticals, Inc | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Urticaria

EP-262-104: An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Escient Pharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed

CALM-CSU: Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=154 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc | N=114 ➔ 154 | Trial completion date: Feb 2025 ➔ Jul 2025 | Trial primary completion date: Jan 2025 ➔ Jun 2025

Enrollment change • Trial completion date • Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

CALM-CIndU: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (clinicaltrials.gov) - P1 | N=33 | Active, not recruiting | Sponsor: Escient Pharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Urticaria

EASE: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: Escient Pharmaceuticals, Inc | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Incyte Completes Acquisition of Escient Pharmaceuticals (Businesswire) - "Incyte...today announced that it has completed its acquisition of Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders....Through this transaction, Incyte has added EP262 and EP547 to its portfolio."

M&A • Atopic Dermatitis • Chronic Spontaneous Urticaria • Immunology • Pruritus • Urticaria

EASE: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Escient Pharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

CALM-CSU: Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc | Trial completion date: Nov 2024 ➔ Feb 2025 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Incyte Announces Acquisition of Escient Pharmaceuticals and its Pipeline of First-in-Class Oral MRGPR Antagonists (Businesswire) - "Incyte...and Escient Pharmaceuticals...have entered into a definitive agreement under which Incyte has agreed to acquire Escient, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist....By blocking MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell-mediated diseases including atopic dermatitis (AD), chronic inducible urticaria (CIndU) and chronic spontaneous urticaria (CSU)....EP547 is a first-in-class oral MRGPRX4 antagonist with the potential to treat cholestatic pruritus and other conditions with severe pruritus....Under the terms of the agreement, Incyte will acquire Escient and its assets for $750 million plus Escient’s net cash remaining at the close of the transaction, subject to customary adjustments."

M&A • Atopic Dermatitis • Chronic Spontaneous Urticaria • Pruritus • Urticaria

MRPGRX2 Antagonist EP262 Inhibits Mast Cell Activation and Attenuates Disease in a Mouse Model of Atopic Dermatitis (AAD 2024) - "The MRGPRX2 antagonist, EP262, attenuated HDM/SEB-induced atopic dermatitis disease phenotypes and mast cell-associated transcriptional changes. Results support further evaluation of EP262 as a novel oral treatment for atopic dermatitis and other mast cell-mediated diseases."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

CALM-CIndU: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc

Trial completion date • Trial primary completion date • Dermatology • Immunology • Urticaria

EASE: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc

Trial completion date • Trial initiation date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

CALM-CSU: Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc

Trial completion date • Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

CALM-CIndU: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc | Phase classification: P1b ➔ P1

Phase classification • Dermatology • Immunology • Urticaria

CALM-CSU: Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc

New P2 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

CALM-CIndU: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc

New P1 trial • Dermatology • Immunology • Urticaria

MRPGRX2 Antagonist EP262 Prevents Inflammation and Disease in a Mouse Model of Atopic Dermatitis (AAD 2023) - "EP262 is a MRGPRX2 antagonist that inhibits HDM/SEB-induced atopic dermatitis disease phenotype and inflammation. EP262 is a potential novel oral treatment for atopic dermatitis and other mast cell-mediated diseases."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MRGPRX2 Antagonist EP262 Potently Inhibits Agonist-Induced Mast Cell Degranulation In Vitro and In Vivo (AAAAI 2023) - "EP262 is a potent MRGPRX2 inverse agonist which inhibits agonist-induced mast cell degranulation both in vitro and in vivo, supporting potential utility as a therapeutic treatment for a broad range of mast cell mediated diseases."

Preclinical