COYA 303 / Coya Therap - LARVOL DELTA

Coya Therapeutics Announces Publication of Preclinical Study Demonstrating Combination Immunomodulatory Effects of COYA 303 in a Well-Established Model of Peripheral and CNS Inflammation (Businesswire) - "Peripherally, the combination treatment produced significant reductions in pro-inflammatory myeloid interleukin 6 (IL-6) and tumor necrosis factor (TNF) transcript expression, while increasing arginase-1 (ARG1) expression. The combination also enhanced Treg-associated IL-2 receptor alpha (IL-2Ra, also known as CD25), transforming growth factor beta 1 (TGF-b1), and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immunomodulatory transcript expression, relative to monotherapies."

Preclinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Dementia • Inflammation

Upcoming Expected Milestones 2026 (Businesswire) - "2H 2026: Complete enrollment in the ALSTARS Phase 2 trial; 2H 2026: Initiate a Phase 2 study evaluating COYA 302 for the treatment of FTD; 2H 2026: Announce biomarker data from the completed investigator-initiated study in patients with FTD; 2H 2026: Report additional single-cell proteomics data from the completed ALS and AD investigator-initiated trials; 2H 2026: Publish in vivo data on COYA 303 in an inflammatory animal model of peripheral and CNS inflammation."

New P2 trial • P1 data • P2 data • Preclinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Frontotemporal Lobar Degeneration

Upcoming Expected Catalysts for 2026 (Businesswire) - "June 2026: Scientific presentations at upcoming 5th Annual ALS Drug Development Summit and ENCALS (European Network to Cure ALS); 2H 2026: Targeting full enrollment of our ALSTARS Phase 2 trial; 2H 2026: Initiate Phase 2a study evaluating COYA 302 for the treatment of FTD; 2H 2026: Report additional single cell proteomics data from the completed ALS and AD investigator-initiated trials; 2H 2026: Publication of COYA 303 in vivo data in inflammatory animal model of peripheral and CNS inflammation."

Enrollment status • P2a data • Preclinical • Alzheimer's Disease • Frontotemporal Lobar Degeneration • Inflammation

Coya Therapeutics Reports Third Quarter Financial Results and Provides a Corporate Update (Businesswire) - "Presentation and publication of the comprehensive in-vivo animal data set of COYA 303 (LD IL-2 + CTLA-4 Ig) and impact on systemic and brain inflammation."

Preclinical • CNS Disorders • Inflammation

Coya Therapeutics' COYA 303 Shows Promising Central Nervous System (CNS) Anti-inflammatory Effects and Systemic Regulatory T Cell (Treg) Enhancing Effects in a Preclinical Animal Inflammation Model (PRNewswire) - "Upon completion of the full data set, Coya intends to present and/or publish the findings in a peer-reviewed forum....Highlights from Cohort 1: COYA 303 produced significant systemic and CNS immunomodulatory effects in the LPS model of inflammation; COYA 303 significantly (a) enhanced Treg numbers and suppressive function, (b) reduced peripheral activated myeloid cells and (c) attenuated neuroinflammation in the cortex and hippocampus."

Preclinical • Alzheimer's Disease • Inflammation

Upcoming Expected Catalysts for 2025 (PRNewswire) - "ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in tracking progression and survival in patients with ALS; Report new proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer's disease (AD); Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with Frontotemporal Dementia (FTD); Top-line data for COYA 303 in an in-vivo inflammatory animal model."

Clinical data • Preclinical • Alzheimer's Disease • Frontotemporal Lobar Degeneration

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2024 Financial Results (Businesswire) - "Q2 2025: Submission of additional nonclinical data to support the start of the COYA-302 Phase 2 trial in patients with ALS; Upon IND acceptance and first patient dosing of COYA-302 in ALS, eligible to receive milestone payments of $8.4 million from strategic partner, Dr. Reddy’s Laboratories (DRL); Q2 2025: Publication of COYA-303 combination mechanistic data; Q2 2025: Publication of data documenting role of inflammation in Parkinson’s Disease; Q2 2025: ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS."

Biomarker • Clinical data • IND • Preclinical • Amyotrophic Lateral Sclerosis • Immunology • Inflammation

Coya Therapeutics to Participate in KOL Call Hosted by BTIG to Discuss the Potential Treatment of Alzheimer’s Disease Using GLP-1 Agonists and Combinations (Businesswire) - "Coya Therapeutics, Inc...announces that Chief Executive Officer Arun Swaminathan, Ph.D. and Dr. Stanley H. Appel, Professor of Neurology, Houston Methodist Hospital will participate in a BTIG hosted KOL webcast 'Is Alzheimer’s next for GLP-1s and Combos?' on February 27, 2025 to discuss the potential treatment of Alzheimer’s disease using GLP-1 agonists and combination therapy...Coya recently announced the expansion of its investigational pipeline and advancement of COYA 303 for the treatment of inflammatory diseases."

Clinical data • Alzheimer's Disease • Inflammation

Coya Therapeutics Announces Pipeline Expansion - COYA 303: COYA 301 in Combination with GLP-1 Receptor Agonist for the Treatment of Inflammatory Diseases (Businesswire) - "Coya Therapeutics...announces the expansion of its investigational pipeline and advancement of COYA 303 for the treatment of inflammatory diseases. Sustained inflammatory responses driven by dysfunctional immune regulation is a hallmark of serious autoimmune and neurodegenerative diseases...In a preclinical study, COYA 303 exhibited a dual immunomodulatory mechanism of action resulting in an additive/synergistic anti-inflammatory effect, which the Company believes was due to increased Treg function and suppressed pro-inflammatory myeloid cells and responder T cells. Coya intends to publish the results of this study in a peer-reviewed publication in the first half of 2025 and has filed several patent applications to protect the compound....Following the positive results of this study, Coya intends to continue ongoing strategic discussions to advance COYA 303 through IND-enabling studies and into the clinic."

Pipeline update • Preclinical • CNS Disorders • Immunology • Inflammation