Coya Therapeutics Announces Successful Pre-IND and Type C Meetings with the FDA to Advance the Development of COYA 302 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Rhea-AI Summary

Coya Therapeutics, Inc. (COYA) has successfully obtained constructive feedback and reached alignment with the FDA on key areas involved in the development of COYA 302, a dual-mechanism investigational biologic combination therapy for the treatment of ALS. This significant step paves the way for the submission of the IND application to the FDA in the second quarter of 2024 and the initiation of a well-controlled, double-blind clinical trial of COYA 302 in ALS patients. The company has secured a cash runway into 2026 through recent out-licensing and private placement transactions, positioning it to deliver value to patients and shareholders.

Insights

Biotech Industry Analyst

Advancements in biotechnology, particularly those that involve regulatory milestones, are critical pivot points for companies like Coya Therapeutics. The successful meetings with the FDA and the alignment on the IND application for COYA 302 indicate a positive trajectory in the drug development process. It's essential to note that pre-IND and Type C meetings are strategic discussions that can greatly influence the design and execution of clinical trials, as well as the drug approval timeline.

For stakeholders, the progress towards an IND submission for a potential ALS treatment is significant. ALS, or amyotrophic lateral sclerosis, is a progressive neurodegenerative disease with limited treatment options. The development of COYA 302, which leverages a dual-mechanism approach, could potentially address a substantial unmet medical need. The synergistic mechanisms involved in COYA 302, aiming to modulate inflammatory pathways, reflect a novel therapeutic strategy that could differentiate it from existing treatments.

Financially, Coya's recent out-licensing and private placement transactions, which extend the company's cash runway into 2026, provide a buffer for the company to reach significant clinical milestones without immediate capital concerns. This financial stability is crucial as clinical trials, especially in the biotech sector, are capital-intensive and high-risk endeavors.

Clinical Trials Expert

The planned initiation of a well-controlled, double-blind clinical trial for COYA 302 post-IND acceptance is a testament to the rigorous standards required for potential ALS therapies. Such a trial design is the gold standard for determining the efficacy and safety of new treatments. The alignment with the FDA on CMC, preclinical and clinical activities is indicative of a thorough preparatory phase, which is essential for a smooth transition into human trials.

Investors should be aware of the risks inherent in clinical trials, particularly in the case of neurodegenerative diseases like ALS, where the patient population is heterogeneous and the disease progression can be variable. However, the establishment of a clear path towards the IND submission and the initiation of clinical trials also presents an opportunity for Coya to potentially expedite the development process if the trial outcomes are positive.

Furthermore, the expertise and guidance from the FDA throughout the development program can serve to mitigate some of the regulatory risks and support the potential for a successful trial outcome. This, in turn, could have a considerable impact on the company's valuation and future fundraising efforts.

Financial Analyst

The strategic moves by Coya Therapeutics, including securing funding that extends their operational runway, are indicative of a company positioning itself for long-term success. The extension of the cash runway into 2026 allows the company to focus on the clinical development of COYA 302 without the immediate pressure of fundraising. This is particularly important given that biotech companies often face volatility around key clinical and regulatory milestones.

Investors often scrutinize the cash burn rates and capital raising strategies of biotech companies, as these factors can significantly influence share prices. The positive feedback from the FDA and the clear regulatory path forward could enhance investor confidence and potentially lead to an uptick in stock valuation, assuming the market perceives this news as a de-risking event for the company's lead program.

However, it's also important to consider the competitive landscape and the fact that successful clinical outcomes are not guaranteed. The implications for long-term valuation will largely depend on the trial results and the ability of COYA 302 to meet efficacy and safety endpoints, which are critical for market approval and commercial success.

• Coya has a clear path towards submission of the IND application to the FDA in the second quarter of 2024, with a planned initiation of a well-controlled, double-blind clinical trial of COYA 302 in patients with ALS upon acceptance of the IND

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (“Coya”), a clinical-stage biotechnology company today announced successful meetings with the U.S. Food and Drug Administration (FDA) following a pre-IND (Investigational New Drug) meeting and a Type C meeting intended to seek advice from the Agency to reach alignment on multiple aspects of the planned development program in support of an IND application of COYA 302 for the treatment of ALS.

COYA 302 is a dual-mechanism investigational biologic combination therapy comprised of proprietary low dose IL-2 and fusion protein CTLA-4 Ig. Low dose IL-2 enhances anti-inflammatory Treg function and numbers while the fusion protein CTLA-4 Ig is intended to suppress pro-inflammatory cell function enabling potentially synergistic mechanisms in modulating inflammatory pathways.

As a result of the interactions with the FDA, Coya has obtained constructive feedback and has reached alignment on key areas involved in the development of COYA 302, including CMC (chemistry, manufacturing, and controls), preclinical and clinical activities for the IND application. The results of the regulatory meetings constitute a significant step towards the submission of the IND application to the FDA in the second quarter of 2024, and initiation of a well-controlled, double-blind clinical trial of COYA 302 in patients with ALS upon acceptance of the IND. Coya plans to continue working closely with the FDA over the course of the COYA 302 development program.

Dr. Fred Grossman, President and Chief Medical Officer of Coya stated, “This important feedback allows us to advance our development program in ALS with a planned double-blind controlled study, with the potential for bringing forward a much-needed therapy for ALS patients.”

Howard H. Berman, Ph.D., CEO of Coya stated: “We believe that gaining alignment with FDA through multiple regulatory meetings on the path to filing an IND in Q2, 2024 is an important next step in advancing the program in patients with ALS. With the recent out-licensing transaction and private placement transaction securing Coya a cash runway into 2026 and through completion of this study, we believe that we are in a position to execute and deliver value to patients and shareholders.”

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 CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS. 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 LD IL-2 and CTLA-4 Ig in small cohort of patients with ALS, conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D. 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 (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), suggesting significant amelioration in the progression of the disease 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. Treg suppressive function at 24 weeks (79.9±9.6) and 48 weeks (89.5±4.1) were significantly higher compared to baseline (62.1±8.1) (p<0.01), suggesting enhanced and durable Treg suppressive function over the course of treatment. In contrast, Treg suppressive function (mean ±SD) was significantly decreased at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3±8.1 vs. 89.5±4.1, p <0.05).

The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease of 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 Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, is a rare neurological disease that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement. About 20,000 people live with ALS in the United States and approximately 5,000 new cases are diagnosed every year. The disease is progressive, meaning the symptoms get worse over time. The functional status of ALS patents declines about 1 point per month on average, as measured by the Revised ALS Function Rating Scale¹, or ALSFRS-R, a validated tool to monitor the progression of the disease. ALS has no cure, and the currently approved drug treatments provide limited benefit to patients. ALS is a type of motor neuron disease. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear.²

1. Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725. doi: 10.1212/WNL.0000000000000951.
2. National Institutes of Health (NIH) Website (https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als), accessed on January 4, 2023.

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’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240105424614/en/

Investor Contact

David Snyder

david@coyatherapeutics.com

Hayden IR

James Carbonara

James@haydenir.com

646-755-7412

Media Contact

Jessica Starman

media@coyatherapeutics.com

Source: Coya Therapeutics, Inc.

FAQ

What is the status of Coya Therapeutics, Inc. (COYA) in the development of COYA 302?

Coya has successfully obtained constructive feedback and reached alignment with the FDA on key areas involved in the development of COYA 302, a dual-mechanism investigational biologic combination therapy for the treatment of ALS.

What is the timeline for the submission of the IND application to the FDA for COYA 302?

The submission of the IND application to the FDA for COYA 302 is planned for the second quarter of 2024.

What is the recent financial position of Coya Therapeutics, Inc. (COYA)?

Coya has secured a cash runway into 2026 through recent out-licensing and private placement transactions, positioning it to deliver value to patients and shareholders.