abatacept/aldesleukin (COYA 302) / Coya Therap, Houston Methodist Hospital, Dr. Reddy’s - LARVOL DELTA

Coya Therapeutics…announced that the 100th patient has been enrolled in the Company’s ongoing Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302, Coya’s combination of proprietary low-dose IL-2 and CTLA-4 Ig, for the treatment of amyotrophic lateral sclerosis (ALS) (Businesswire) - "Based on current enrollment trends, Coya anticipates completing full enrollment of 120 participants in sufficient time to permit reporting topline data in early Q2 of 2027....The ALSTARS Trial is a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of COYA 302 in patients with ALS. Approximately 120 subjects will be randomized 1:1:1 to receive one of two pre-specified dosing regimens of COYA 302 or placebo during a 24-week double-blind treatment phase."

Enrollment status • P2/3 data • Amyotrophic Lateral Sclerosis

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

ALSTARS: Study of COYA 302 for the Treatment of ALS (clinicaltrials.gov) - P2/3 | N=120 | Recruiting | Sponsor: Coya Therapeutics | Phase classification: P2 ➔ P2/3

Phase classification • Amyotrophic Lateral Sclerosis • CNS Disorders

ALSTARS: A Precision Immunomodulatory Phase 2 Trial Of Coya 302 Targeting Regulatory T Cells And Neuroinflammation In ALS (ENCALS 2026) - "COYA 302 combines CTLA4-Ig (abatacept) to suppress inflammation together with low-dose (LD) IL-2 to restore Treg neuroprotective function. The primary endpoint is the ALSFRS-R change at 24 weeks, with other clinical endpoints including CAFS, respiratory status, NfL, and pharmacodynamic and immunologic endpoints related to the proposed mechanism of action.Results COYA 302 treatment is expected to reduce downstream motor neuron injury from chronic inflammation, slowing ALS progression. The ALSTARS trial combines a unique therapeutic mechanism with novel design to rigorously test COYA 302 as an ALS treatment.Conclusion ALSTARS combines Treg-directed immunotherapy with NfL-based stratification, a mechanism-informed, biomarker-enriched trial design to enhance signal detection and expedite development of this immunomodulatory therapy for ALS."

Immunomodulating • IO biomarker • P2 data • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • IL2 • NEFL

Coya Therapeutics to Present ALSTARS Trial Design at the ENCALS 2026 Meeting (Businesswire)

Clinical protocol • Amyotrophic Lateral Sclerosis

Coya Therapeutics Announces the First Cohort of Patients in the ALSTARS Trial Have Begun the Blinded Active-Treatment Extension Phase (Coya Press Release) - "Patients who complete the 24-week placebo-controlled double-blind phase enter the blinded extension phase of the study and continue on their regimen from the first phase; placebo patients are re-randomized to receive one of the two pre-specified dosing regimens of COYA 302 for a total of 24-weeks to provide a total of up to 48 weeks of data on COYA 302."

Trial status • Amyotrophic Lateral Sclerosis

Coya Therapeutics to Present ALSTARS Trial Design at the 5th ALS Drug Development Summit (Businesswire)

Clinical protocol • Trial status • Amyotrophic Lateral Sclerosis

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 Has Been Granted U.S. FDA Fast Track Designation for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) (Yahoo Finance)

Fast track • Amyotrophic Lateral Sclerosis

Coya Therapeutics Announces Publication Demonstrating Correlation Between Longitudinal Biomarker Data and Clinical Outcomes Supporting the Mechanistic Rationale for COYA 302 in Patients with ALS (Yahoo Finance UK) - "This study used longitudinal serum samples collected between January 2018 to December 2022...All three biomarkers were increased in ALS patients compared to controls. 4-HNE and LBP were increased at ALS diagnosis and continued to increase as disease progressed and both biomarkers correlated with disease progression rates and survival. NfL was increased at diagnosis and exhibited a more limited increase over time. Levels of 4-HNE, LBP, and NfL at ALS diagnosis were significantly correlated with length of survival (p < 0.001 for 4-HNE and LBP; p = 0.001 for NfL). Similarly, levels of 4-HNE and LBP were significantly correlated with the rate of disease progression (p < 0.001) as measured by ALSFRS-R."

Retrospective data • Amyotrophic Lateral Sclerosis

Coya Therapeutics to Host Webinar with Leading Medical Experts on Amyotrophic Lateral Sclerosis (ALS) Drug Development, Patient Landscape, and Ongoing Clinical Trial (PharmiWeb) - "...the webinar will explore recent breakthroughs and ongoing challenges in the ALS landscape, including the biological drivers of disease and how advances in drug development are improving the patient experience, while underscoring where significant gaps remain. The discussion will highlight Coya’s novel immunotherapy approach for treating ALS, including the scientific rationale behind its combination therapy COYA 302 and will feature an overview of the Company’s ALSTARS Phase 2 clinical trial, including its design and enrollment information."

Trial status • Amyotrophic Lateral Sclerosis

Coya Therapeutics Announces $11.1 Million Private Placement (Businesswire) - "The Company intends to use the net proceeds to accelerate tech transfer and scale-up manufacturing activities for low dose IL-2 to support the commercial readiness of COYA 302."

Financing • Amyotrophic Lateral Sclerosis

Investigational COYA 302 Shows Feasibility, Preliminary Efficacy in Small Trial of Frontotemporal Dementia (NeurologyLive) - "The trial featured 9 patients with FTD who received subcutaneous CTLA4-IgG, along with a 5-day course of low-dose IL-2 every 4 weeks for a treatment period lasting 22 weeks in total. Although not powered for significance, results revealed relatively unchanged scores on Montreal Cognitive Assessment (MoCA), a cognitive outcome, over the 22-week period (baseline: 13.5; week 22: 14). While there were slightly higher Clinical Dementia Rating-Frontotemporal Lobe Dementia (CDR-FTLD) scores at week 22, these were still considered unchanged relative to baseline (baseline: 4.8; week 22: 5.5)."

P1 data • Dementia • Frontotemporal Lobar Degeneration

Coya Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Frontotemporal Dementia (FTD) (Yahoo Finance)

IND • Frontotemporal Lobar Degeneration

Coya expects to announce topline results from the previously announced investigator-initiated open-label study evaluating low-dose IL-2 and CTLA4-Ig in patients with mild-to-moderate FTD in the coming weeks. (Yahoo Finance)

P1 data • Frontotemporal Lobar Degeneration

Coya Therapeutics Announces Patients Have Been Dosed in the ALSTARS Trial of COYA 302 for the Treatment of ALS (Businesswire) - "The ALSTARS Trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of COYA 302 in patients with amyotrophic lateral sclerosis (ALS) being conducted at clinical sites in the United States and Canada...COYA will receive a $4.2 million milestone payment from its strategic partner, Dr. Reddy’s Laboratories (DRL), for the achievement of this milestone."

Financing • Trial status • Amyotrophic Lateral Sclerosis

Upcoming Expected Catalysts (Businesswire) - "First patient enrolled in COYA 302 ALSTARS Trial; First patient dosed in COYA 302 ALSTARS Trial; Upon first patient dosing of COYA 302 in ALS, expect to receive $4.2 million milestone payment from strategic partner, Dr. Reddy’s Laboratories (DRL)...ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS; Report additional single cell 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 FTD; IND submission for FTD anticipated in Q4 2025."

Clinical data • Financing • IND • Trial status • Amyotrophic Lateral Sclerosis • Frontotemporal Lobar Degeneration

Coya Therapeutics Announces Completion of Patient Enrollment of an Investigator-Initiated, Open-Label Study with Low-Dose IL-2 and CTLA4-Ig Combination Treatment in Patients with Mild to Moderate Frontotemporal Dementia (Coya Press Release) - "Study patients received subcutaneously administered CTLA4-Ig, followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up....The trial is progressing according to the study protocol and no serious adverse events or discontinuations due to safety issues have been reported. Study completion is anticipated in Q4 2025 with topline to follow. Following database lock and analysis of the data, the Company plans to release the results of the study."

Clinical data • Enrollment closed • Trial completion date • Frontotemporal Lobar Degeneration

ALSTARS: Study of COYA 302 for the Treatment of ALS (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Coya Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Launches the ALSTARS Trial, a Phase 2 Clinical Study to Assess the Efficacy and Safety of COYA 302 in Amyotrophic Lateral Sclerosis (PRNewswire) - "The ALSTARS Trial is a well powered randomized, multi-center, double-blind, placebo-controlled, 24-week study of COYA 302 in people with Amyotrophic Lateral Sclerosis (ALS). Patients completing the initial 24-week treatment will be invited to participate in a 24-week blinded extension period, during which all participants will receive COYA 302. The ALSTARS Trial will enroll 120 ALS participants at approximately 25 centers in the United States and Canada."

Trial status • Amyotrophic Lateral Sclerosis

ALSTARS: Study of COYA 302 for the Treatment of ALS (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Coya Therapeutics

New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) (PRNewswire) - "FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS....The approval of the IND by the FDA triggers a $4.2 million milestone payment to Coya from DRL."

Financing • IND • New P2 trial • Amyotrophic Lateral Sclerosis

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

Upcoming Expected Catalysts for 2025 (PRNewswire) - "Upon IND acceptance and first patient dosing of COYA 302 in ALS, Coya will receive milestone payments of $8.4 million from strategic partner, Dr. Reddy's Laboratories (DRL)....'We also plan to submit an IND for FTD by the end of the year.'"

Financing • IND • Amyotrophic Lateral Sclerosis • Frontotemporal Lobar Degeneration

FDA misses IND deadline for Coya’s ALS asset, cites lack of resources (FierceBiotech) - "On July 29, the federal drug agency told Coya it would not meet the initial review goal date of July 30, according to a Securities and Exchange Commission filing from the Houston-based biotech. If approved, the IND application would allow Coya to launch a phase 2 trial for its investigational amyotrophic lateral sclerosis (ALS) treatment. The FDA said it would deliver a decision before or by Aug. 29, according to the filing....For Coya, the delay will stretch out the time—and the company’s cash runway—that the biotech must wait to see if it can start clinical trials for COYA 302, its lead biologic investigational product that the biotech dubs a 'pipeline in a product'."

FDA event • Amyotrophic Lateral Sclerosis