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

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

Coya Therapeutics Announces Issuance of New U.S. Patent Protecting Methods of Producing Recombinant Human (rh) Interleukin-2 (aldesleukin) Liquid Formulations (Coya Press Release) - "Coya Therapeutics, Inc...announced the issuance of a U.S. patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. In particular, the U.S. Patent and Trademark Office (USPTO) has granted patent number US 12,312,389 B2, which covers methods of producing highly stable liquid formulations of IL-2 (aldesleukin). Through an existing agreement, Coya has the exclusive in-vivo rights to this patent and other related intellectual property spanning multiple indications both as monotherapy and combination therapies...Coya is on track and plans to submit the IND for COYA 302 (a proprietary combination of the low dose-rhIL-2 + CTLA4-Ig) by the end of June supporting the initiation of the Phase 2b study in patients with ALS"

IND • New P2b trial • Patent • Amyotrophic Lateral Sclerosis

Coya Therapeutics Reports First Quarter Financial Results and Provides a Corporate Update (Businesswire) - "Research and development (R&D) expenses were $5.2 million for the three months ended March 31, 2025, compared to $3.1 million for the three months ended March 31, 2024. The change was primarily due to a $1.5 million increase in our preclinical expenses primarily due to the Company’s preclinical advancement of COYA 302 in ALS, a $0.4 million increase in internal research and development expenses, and a $0.1 million increase in sponsored research."

Commercial • Amyotrophic Lateral Sclerosis

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 Provides a Corporate Update and Reports Fiscal 2024 Financial Results (Businesswire) - "2H 2025: 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); 2H 2025: Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD; 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with FTD."

Clinical data • IND • P2 data • Alzheimer's Disease • Dementia

Coya Therapeutics Provides Enrollment Update of the Investigator-Initiated Phase 1 Study of Low Dose Interleukin-2 (LD IL-2) + CTLA4-Ig Fusion Protein in Patients with Frontotemporal Dementia (FTD) (Businesswire) - "Coya Therapeutics, Inc...announces that five of eight patients have been enrolled in the investigator-initiated academic study of LD IL-2 + CTLA4-Ig combination in patients with Frontotemporal Dementia (FTD). The study is being conducted by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital. Topline results of the study will be leveraged to inform and finalize the planned trial design of a Company-sponsored, randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD. Coya has been awarded $5 million by the Alzheimer’s Drug Discovery Foundation (ADDF) to support the development of COYA 302 in FTD."

Enrollment status • Financing • CNS Disorders • Dementia

Coya Therapeutics Provides a Corporate Update and Reports Unaudited Third Quarter 2024 Financial Results (Businesswire) - "Q2 2025: Submission of additional data to support the start of the COYA-302 Phase 2 trial in patients with ALS...2H 2025: Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD; 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with FTD."

Clinical data • IND • P2 data • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia

Coya Therapeutics Announces Subcutaneously Administered COYA 302 Elicits Direct Anti-Inflammatory Effect in Brain in a Preclinical Inflammatory Mouse Model of Parkinson’s Disease (Businesswire) - "In an inflammatory mouse model of PD, subcutaneous injections of COYA 302 significantly reduced inflammation and microglial activation in nigrostriatal brain regions responsible for motor control...Microglial inhibition may hold promise as a therapeutic strategy to delay the progression of PD. Additionally, subcutaneous injections of COYA 302 resulted in reductions in astrocyte numbers and their activation (astrogliosis) in the nigrostriatal pathway. It is known that pathogenic astrocyte activation leads to neurodegeneration in PD, and mitigating its damage may be another therapeutic target."

Preclinical • CNS Disorders • Parkinson's Disease

Coya Therapeutics Provides a Corporate Update and Reports Unaudited Second Quarter 2024 Financial Results (Businesswire) - "On August 9, 2024, FDA provided feedback that additional non-clinical toxicology/pharmacology data must be submitted prior to initiating our planned randomized, double-blind, placebo-controlled Phase 2 study of our first-in-class biologic combination COYA 302 in patients with ALS. Coya intends to discuss the recommendations with the FDA in 4Q 2024 to align on our revised non-clinical package to enable the implementation of the study...We believe data from this Phase 1 trial is supportive of COYA 302 as a potential treatment for ALS and submitted an IND to the FDA in the second quarter of 2024...Lastly, in Parkinson’s disease, we anticipate releasing animal model data highlighting the potential therapeutic effects of COYA 302 by the end of the year."

FDA event • IND • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Parkinson's Disease

Coya Therapeutics Announces that Results from a Double-Blind Placebo-Controlled Study in Alzheimer’s Disease will be presented on October 29, 2024 at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid (Businesswire) - "Coya Therapeutics, Inc...announces that data from the IIT, a double-blind, placebo-controlled, phase 2 clinical trial of interleukin-2 (IL-2) in patients with mild to moderate Alzheimer's Disease, conducted at Houston Methodist Research Institute and supported by the Gates Foundation and the Alzheimer’s Association will be presented at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24), to be held in Madrid, Spain on October 29 - November 1, 2024."

P2 data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics faces FDA hold on ALS drug study (Investing.com) - "Coya Therapeutics, Inc...has encountered a regulatory setback with the U.S. Food and Drug Administration (FDA) requiring additional non-clinical data before proceeding with a planned study on its investigational drug for Amyotrophic Lateral Sclerosis (ALS). The FDA's request for more information was communicated to the company via email on July 12, 2024, delaying the initiation of the Phase 2 clinical trial...However, the FDA's recent correspondence has put a hold on the study's commencement, pending the submission of the requested additional data. Coya Therapeutics has been advised to expect further details on the FDA's requirements within the next 30 days."

FDA event • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Expands Sponsored Research Collaboration with Houston Methodist Research Institute Along with Funding from the Johnson Center for Cellular Therapeutics to Advance Regulatory T Cell Exosome Platform into the Clinic (Businesswire) - "Coya Therapeutics...announces the expansion of its research collaboration with the Houston Methodist Research Institute...through a sponsored research agreement (SRA) covering multiple initiatives...Coya and HMRI will advance the development of multiple patented modalities of exosomes, including full characterization of the nanovesicles, and GMP manufacturing to enable a first-in-human academic clinical study. Furthermore, Coya will continue the characterization and validation of several clinical biomarkers in patients with Amyotrophic Lateral Sclerosis, Alzheimer’s Disease, Frontotemporal Dementia, and Parkinson’s Disease....In addition, Coya and HMRI will continue exploring the potential synergy of COYA 301 (LD IL-2) with other relevant drug products, following the innovative approach of COYA 302 (LD IL-2 + CTLA4-Ig) targeting multiple paths involved in the pathophysiology of severe neurodegenerative and autoimmune diseases."

Licensing / partnership • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Immunology • Parkinson's Disease

Coya Therapeutics Announces Publication of ALS Study in Peer-Reviewed Journal Frontiers in Neurology (Businesswire) - P1 | N=5 | NCT06307301 | "'Coya remains on track to file its Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for its proposed randomized double blind placebo controlled study for LD IL-2 + CTLA4-Ig in ALS this month (June, 2024).'...Treatment was well tolerated among all patients. There were no serious adverse events...For all 4 participants, the mean rate of change in the ALSFRS-R over the first 24 weeks was stable (+0.04 points/month). During this time period, the ALSFRS-R improved by 4 points in participant #1, improved by 3 points in participant #2, was unchanged in participant #3, and decreased by 6 points in participant #4."

IND • P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Announces the Completion of a Controlled Phase 2 Study of Low Dose Interleukin-2 (LD IL-2) in Patients with Alzheimer’s Disease (Businesswire) - P2 | N=NA | "Coya Therapeutics, Inc...announces the completion of a randomized, double-blind, placebo-controlled Phase 2 study of LD IL-2 in patients with mild-to-moderate AD....Topline results of the study are still anticipated to be reported in summer of 2024....In addition, an evaluation of cognitive function showed that administration of LD IL-2 resulted in a statistically significant improvement in mean Mini-Mental State Examination (MMSE) scores during the treatment phase, compared to mean MMSE score at baseline (p=0.015). Consistent with the positive trend in MMSE score, mean scores in ADAS-Cog and CDR-SB scales did not significantly change at the end of treatment with LD IL-2, compared to pre-treatment baseline scores, indicating no cognitive decline as measured by these validated instruments."

P2 data • Trial completion • Alzheimer's Disease • CNS Disorders

Coya Therapeutics to Participate in the 3rd Annual ALS Drug Development Summit (Businesswire) - "Coya Therapeutics, Inc...announces that President and Chief Medical Officer Dr. Fred Grossman, D.O., FAPA will participate in the 3^rd Annual ALS Drug Development Summit being held May 21 – 23 at the Hyatt Regency in Boston."

Clinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology

Coya Therapeutics Presents ALS Biomarker Data at Society of Neuroimmune Pharmacology Conference (Yahoo Finance) - "Coya Therapeutics, Inc...announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board and Dr. David Beers, Ph.D., Associate Research Professor of Neurology, Houston Methodist, will present biomarker data today as part of a panel presentation at the Society of Neuroimmune Pharmacology Conference....4-HNE serum levels are significantly elevated in ALS patients compared to healthy controls; 4-HNE serum levels correlate with the rate of disease progression in ALS patients (ALSFRS points/month) - The higher the 4-HNE serum level, the faster the progression; 4-HNE serum levels correlate with survival from onset and diagnosis to death -The higher the 4-HNE serum level, the shorter the survival..."

Clinical data • Amyotrophic Lateral Sclerosis • CNS Disorders