SYX-5219 / Sitryx - LARVOL DELTA

Sitryx Completes Enrollment in Phase 1b Trial of First-in-Class Oral PKM2 Modulator SYX-5219 in Atopic Dermatitis (GlobeNewswire) - "Phase 1b trial on track to readout in Q4 2026."

Enrollment closed • Atopic Dermatitis

A novel oral pyruvate kinase M2 (PKM2) modulator for atopic dermatitis (SYX-5219) demonstrates favorable safety, pharmacokinetics, target engagement and evidence of type 2 immunomodulation: results from a first-in-human Phase 1a study. (SID 2026) - "SYX-5219 demonstrates a favorable profile supporting further evaluation of this novel immunometabolic approach. A Phase 1b study to evaluate SYX-5219 in adults with moderate-to-severe AD is ongoing."

Clinical • First-in-human • Immunomodulating • Late-breaking abstract • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • PKM

First-in-Class Oral PKM2 Modulator SYX-5219 Phase 1a Trial Data to be Presented at SID 2026 (GlobeNewswire) - "SYX-5219 was safe and well tolerated across all doses, with no serious, unexpected or severe adverse events or treatment-related lab abnormalities. At steady state, exposures were within a model-predicted range associated with efficacy in preclinical dermatitis models. Exposure-dependent target engagement was observed, with pyruvate kinase activity reaching ≥EC95 at doses ≥30 mg, once daily...A Phase 1b clinical trial evaluating SYX-5219 in adults with moderate to severe atopic dermatitis commenced in January 2026 and will investigate the safety, tolerability and initial efficacy of SYX-5219 in up to 45 adult patients in the United States and Europe. The Company expects to receive data from the trial by year end."

First-in-human • P1 data • Atopic Dermatitis

A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=149 | Recruiting | Sponsor: Sitryx Therapeutics Ltd

First-in-human • New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SYX-5219-101: A multi-part, adaptive, Phase 1, first time in human study in healthy participants and participants with atopic dermatitis (AD) to assess the safety, tolerability, pharmacokinetics (PK) of single ascending (SAD), multiple ascending doses (MAD) and selected dose of SYX-5219 (AD Participants) (clinicaltrialsregister.eu) - P1 | N=28 | Recruiting | Sponsor: Sitryx Therapeutics Limited

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SYX-5219-102: The effect of SYX-5219 on an immune response in the skin. (clinicaltrialsregister.eu) - P1 | N=20 | Completed | Sponsor: Sitryx Therapeutics Limited | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SYX-5219-101: A multi-part, adaptive, Phase 1, first time in human study in healthy participants and participants with atopic dermatitis (AD) to assess the safety, tolerability, pharmacokinetics (PK) of single ascending (SAD), multiple ascending doses (MAD) and selected dose of SYX-5219 (AD Participants) (clinicaltrialsregister.eu) - P1 | N=23 | Recruiting | Sponsor: Sitryx Therapeutics Limited

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SYX-5219-102: The effect of SYX-5219 on an immune response in the skin. (clinicaltrialsregister.eu) - P1 | N=20 | Recruiting | Sponsor: Sitryx Therapeutics Limited

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Sitryx advances development of PKM2 modulator SYX-5219 into atopic dermatitis patients following clinical evidence of immunomodulatory activity (Yahoo Finance) - "Results from completed Phase 1a trial in healthy volunteers showed SYX-5219 was safe and well tolerated with predictable pharmacology and robust target engagement; Additionally, a dose-dependent reduction in TARC, a well-established biomarker of type 2 inflammation, was demonstrated....A Phase 1b clinical trial evaluating SYX-5219 in adults with moderate to severe atopic dermatitis has now commenced with the first patients successfully dosed. This trial will investigate the safety, tolerability and initial efficacy of SYX-5219 in up to 45 adult patients in the United States and Europe."

P1 data • Trial status • Atopic Dermatitis

PKM2 is a promising novel target in atopic dermatitis (ISDS 2025) - "The PKM2 modulator, SYX-5219, has recently entered clinical trials in healthy volunteers and patients with moderate to severe AD. SYX-5219 could address the major unmet needs of AD as a safe oral, convenient and effective therapy for AD."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • CD4 • CORT • FLG • IL13 • IL17A • IL6 • LORICRIN • PKM

Sitryx presents new preclinical data highlighting PKM2 as a promising metabolic target for the treatment of atopic dermatitis at the Inflammatory Disease Skin Summit 2025 (GlobeNewswire) - "PKM2 has been identified as a key enzyme in the central metabolic pathway and shown to be upregulated in inflamed tissues, with Sitryx’s preclinical data demonstrating that it is overexpressed in immune cell infiltrate and in keratinocytes in atopic dermatitis compared to healthy skin. The Company’s novel small molecule PKM2 modulator, developed as a potential atopic dermatitis therapeutic, potently activated PKM2 enzymes in human and preclinical models of inflammatory skin diseases, resulting in a decrease of itch cytokines and normalization of gene expression required for barrier function....The Company expects to initiate the trial in Q1 2026."

New P1 trial • Preclinical • Atopic Dermatitis

Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis (The Manila Times) - "Phase 1b trial to investigate the safety, tolerability and initial efficacy of SYX-5219 in patients with atopic dermatitis starting Q1 2026"

IND • New P1 trial • Atopic Dermatitis

Sitryx initiates Phase 1 clinical trial of potential disease-modifying treatment for atopic dermatitis SYX-5219 (GlobeNewswire) - "Sitryx Therapeutics...today announces the initiation of its first-in-human Phase 1a clinical trial evaluating SYX-5219 for the treatment of atopic dermatitis....The Phase 1a trial, initiated in the UK, is an interventional placebo-controlled study designed to assess the safety, tolerability and pharmacokinetics of SYX-5219 in healthy volunteers. It is the first of a two-part study, with the Phase 1b trial in adults with moderate to severe atopic dermatitis expected to commence later in 2025 in the UK, Europe and the US."

Trial status • Atopic Dermatitis

Sitryx nominates SYX-5219 a novel, oral and targeted PKM2 activator for clinical development in atopic dermatitis (GlobeNewswire) - "Sitryx Therapeutics...has nominated SYX-5219 as the first candidate from its proprietary pipeline to progress to regulatory non-clinical studies to support a clinical trial authorization (CTA). SYX-5219 has the potential to address a broad range of inflammatory diseases and will advance into the clinic for the treatment of atopic dermatitis, the most common inflammatory skin disease....Regulatory submission preparation for SYX-5219 is underway, with clinical trials expected to commence in early 2025. SYX-5219 is expected to be the first program to enter clinical development from Sitryx’s proprietary pipeline of potential therapies that leverage metabolism to modulate immune cell function."

New molecule • New trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology