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)

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) reports progress in its Phase 1 study of low-dose Interleukin-2 (LD IL-2) combined with CTLA4-Ig fusion protein for Frontotemporal Dementia (FTD) treatment. The study has enrolled five out of eight planned patients at Houston Methodist Hospital. The trial aims to evaluate safety, inflammation markers, Treg cell populations, and disease progression.

The company received a $5 million grant from the Alzheimer's Drug Discovery Foundation (ADDF) to support COYA 302 development. Results will guide the design of a planned randomized, double-blinded Phase 2 trial. Recent data presented at AD/PD 2024 showed significantly reduced Treg suppressive function in FTD patients compared to controls, supporting the immune system's role in FTD pathophysiology.

Positive

• Secured $5 million funding from ADDF for COYA 302 development
• Achieved 62.5% enrollment (5 of 8 patients) in Phase 1 study
• Demonstrated significant scientific evidence supporting treatment approach through AD/PD 2024 Conference data

Negative

• None.

Insights

Medical Research Analyst

The Phase 1 study update for Coya Therapeutics' FTD treatment shows promising progress with 5 out of 8 planned patients enrolled. This trial evaluating LD IL-2 + CTLA4-Ig combination therapy is particularly significant as it targets the immune system dysfunction in FTD patients, specifically the compromised Treg cells. The study's findings will directly influence the design of a larger Phase 2 trial of COYA 302, supported by a substantial $5 million ADDF grant. The preliminary data presented at AD/PD 2024 showing significantly reduced Treg suppressive function in FTD patients (p<0.01) validates the therapeutic approach. This mechanistic validation, combined with the multi-pathway strategy of COYA 302, strengthens the scientific rationale for the treatment's potential effectiveness in neurodegenerative diseases.

Financial Analyst

The enrollment progress and $5 million ADDF funding represent significant milestones for Coya Therapeutics, particularly given its market cap of $93 million. The study's positive progression strengthens COYA's position in the neurodegenerative disease space, with potential expansion beyond FTD into other conditions like ALS. The investigator-initiated trial design provides a cost-effective approach to gathering preliminary data, while the ADDF funding significantly reduces the financial burden of the planned Phase 2 trial. The scientific validation of Treg dysfunction in FTD patients adds credibility to COYA's therapeutic approach and could attract additional investor interest in this emerging biotech company.

This open-label Phase 1 study measures safety, peripheral and central inflammation, effects on Treg cell populations, and FTD progression;

Five of the 8 planned FTD subjects have been enrolled to date;

Results of study will inform Coya’s randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, 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.

The current investigator-initiated study is evaluating the effects of LD IL-2 + CTLA4-Ig on a variety of parameters in patients with FTD, including safety, tolerability, Treg cell populations, peripheral and central inflammation, and disease progression. COYA 302 is a proprietary formulation of this biologic combination therapy, comprised of low dose interleukin-2 (LD IL-2) and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin fusion protein (CTLA4-Ig).

Fred Grossman D.O., President and CMO of Coya, stated, “We plan to submit an IND for FTD, and the data from the investigator-initiated study will inform some design features of this planned trial. COYA 302 has potential therapeutic application in a variety of neurodegenerative diseases, starting with ALS and FTD.”

Tregs are dysfunctional and compromised in patients with FTD, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. The combination of LD IL-2 + CTLA4-Ig is believed to have additive and/or synergistic effects on enhancing Treg cell populations and lowering peripheral/central inflammation.

Prior data presented by the investigators at the AD/PD 2024 Conference in March 2024 demonstrated that Treg suppressive function was significantly reduced in patients with FTD, compared to controls (p<0.01), demonstrating that Treg immunomodulatory function is negatively impacted in FTD and peripheral levels of inflammatory cytokines and chemokines are increased, supporting the critical role of the immune system in the pathophysiology of FTD. Treg dysfunction and increased levels of inflammatory cytokines and chemokines have been previously reported by Coya in other serious and progressive neurodegenerative diseases and support the multi-pathway combination approach of COYA 302 to target numerous components of the dysfunctional immune system.

About Frontotemporal Dementia

Frontotemporal dementia (FTD) is the result of damage to neurons in the frontal and temporal lobes of the brain. Many possible symptoms can result, including unusual behaviors, emotional problems, trouble communicating, difficulty with work, or difficulty with walking. FTD is rare and tends to occur at a younger age than other forms of dementia. About 60% of people with FTD are 45 to 64 years old. FTD is progressive, meaning symptoms get worse over time. In the early stages, people may have just one symptom. As the disease progresses, other symptoms appear as more parts of the brain are affected. It is difficult to predict how long someone with FTD will live. Some people live more than 10 years after diagnosis, while others live less than two years after they are diagnosed. There is no cure for FTD, and no treatments slow or stop the progression of the disease.¹

References

1. Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725.

About COYA 302

COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin fusion protein (CTLA4-Ig) and is being developed for subcutaneous administration for the treatment of patients with ALS, FTD, and Parkinson’s Diseases (PD). These mechanisms may have additive or synergistic effects.

In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA-4 Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas). This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale.

During the 48-week treatment period, the therapy was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported.

Patients' disease progression was measured using the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean ALSFRS-R scores at week 24 and week 48 after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline, suggesting that disease progression was ameliorated over the 48-week treatment period. Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period.

The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggested a decrease in these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing.

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system.

Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

COYA 302 – the Company’s lead biologic investigational product, or “Pipeline in a Product,” is a proprietary combination therapy consisting of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach is designed to enhance the number and anti-inflammatory function of Tregs and simultaneously lower the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone.

For more information about Coya, please visit www.coyatherapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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Investor Contact

David Snyder, CFO

david@coyatherapeutics.com

CORE IR

Bret Shapiro

brets@coreir.com

561-479-8566

Media Contacts

For Coya Therapeutics:

Kati Waldenburg

media@coyatherapeutics.com

212-655-0924

Source: Coya Therapeutics, Inc.

FAQ

What is the current enrollment status of COYA's Phase 1 FTD trial?

Five out of eight planned patients have been enrolled in the Phase 1 study of LD IL-2 + CTLA4-Ig combination therapy for FTD at Houston Methodist Hospital.

How much funding did COYA receive from the Alzheimer's Drug Discovery Foundation?

Coya Therapeutics received $5 million from the Alzheimer's Drug Discovery Foundation (ADDF) to support the development of COYA 302 in FTD.

What were the key findings presented by COYA at the AD/PD 2024 Conference?

Data presented showed significantly reduced Treg suppressive function in FTD patients compared to controls (p<0.01), with increased peripheral levels of inflammatory cytokines and chemokines.

What is COYA 302 and how does it work in FTD treatment?

COYA 302 is a proprietary combination therapy of low dose interleukin-2 (LD IL-2) and CTLA4-Ig, designed to enhance Treg cell populations and reduce peripheral/central inflammation in FTD patients.

What are the next steps for COYA's FTD treatment development?

Coya plans to submit an IND and conduct a randomized, double-blinded Phase 2 trial of COYA 302, with the current Phase 1 study results informing the trial design.