Coya Therapeutics Announces Plans for FDA Discussion on ALS Agent COYA 302

Howard Berman, PhD

In recent news, Coya Therapeutics announced its plans to file a request to the FDA about continuing the assessment of its investigational therapy COYA 302, a combined subcutaneous injection of the immune signaling molecule interleukin-2 (IL-2) and CTLA4-Ig, for the treatment patients living with amyotrophic lateral sclerosis (ALS) in a phase 2 clinical trial.^1,2

The company is in preparation for a meeting with the agency to discuss its development plans and ensure that it aligns with expectations and requirements set by the FDA before the submission of the investigational new drug (IND) application. The pre-IND meeting is set to take place in the fall, and Coya noted in a statement that it is hoping to have the application cleared early in the next year, with plans to start the trial soon after.²

“Turning to COYA 302 in patients with ALS, we believe our proof-of-concept clinical data was promising, and we are preparing for a pre-IND meeting with the FDA in the fall of 2023,” Howard Berman, PhD, chief executive officer of Coya, said in a statement.¹ “We hope to have our IND application for a phase 2 trial accepted by the FDA early next year and are optimistic the trial can begin soon thereafter.”

Presented at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, held March 19-22, in Dallas, Texas, recent data from a proof-of-concept study assessing COYA 302 in patients with ALS showed amelioration in the progression of their disease over a 48-week treatment period.³ In a cohort of 4 patients with ALS, the mean ALS Functional Rating Scale-Revised (ALSFRS-R) scores at week 24 (33.75; ±3.3) and week 48 (32.00; ±7.8) were not statistically different to those observed at baseline (33.5; ±5.9).

"Our study with a combination of IL-2 and CTLA4-Ig provided promising results. The therapy was well tolerated, and most significantly it enhanced regulatory T lymphocytes suppressive functions, suppressed markers of oxidative stress, and ameliorated disease progression over 48 weeks. The average patient decline, as measured by ALSFRS-R, is approximately -1-point/month,” Stanley Appel, MD, the Peggy and Gary Edwards Distinguished Chair in ALS research, codirector of the Houston Methodist Neurological Institute, and Chair of the Stanley H. Appel Department of Neurology at Houston Methodist Hospital, said in a statement.³

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COYA 302 is a combination of 2 biologics with a dual mechanism of action, synergistically enhancing proinflammatory T lymphocytes (Treg) function and depleting effector T cells, activated macrophages, and proinflammatory cytokines to further decrease inflammation. One of the many products in development by Coya, COYA 302 includes COYA 301 as part of its mechanism of action. This Treg-enhancing biologic therapy plays a key role in the development, expansion, activity, and survival of Tregs.

The cohort of patients came into the study with a mean decline of 1.1 points per month on ALSFRS-R, and were followed for 48 weeks of treatment with an additional 8-week washout period to conclude the study. Findings showed that Treg suppressive function, expressed as a percentage of inhibition of proinflammatory T cell proliferation, was significantly higher at weeks 24 (79.9; ±9.6) and 48 (89.5; ±4.1) than baseline (62.1; ±8.1; P <.01). These significant effects were seen through the end of the 8-week washout period. In contrast, investigators also observed significantly decreased Treg suppressive function at the end of the 8-week washout period as compared with week 48 (70.3 [±8.1] vs 89.5 [±4.1]; P <.05).

The study reported no discontinuations, no deaths, nor any serious adverse events (AEs), with mild injection site reactions as the most common AE observed. Although analyses are ongoing, data from up to 16 weeks showed decrease in serum biomarkers of inflammation, oxidative stress, and lipid peroxides, which was consistent with the observed enhancement of Treg function.

“In the present study there was no average decline from baseline to 24 weeks and we observed minimal average decline from baseline to 48 weeks, suggesting that IL-2 and CTLA4-Ig may provide a potentially meaningful approach for the 'unmet need' in ALS,” Appel said in a statement.³

REFERENCES
1. Coya Therapeutics, Inc. Provides Business Update and Reports Q2 2023 Unaudited Financial Results. News Release. Coya Therapeutics. Published August 8, 2023. Accessed September 22, 2023. https://ir.coyatherapeutics.com/news/news-details/2023/Coya-Therapeutics-Inc.-Provides-Business-Update-and-Reports-Q2-2023-Unaudited-Financial-Results/default.aspx
2. Lobo A. Coya to meet with FDA about a Phase 2 trial of COYA 302 for ALS. News Release. ALS News Today. Published August 10, 2023. Accessed September 22, 2023. https://alsnewstoday.com/news/coya-meet-fda-about-phase-2-trial-coya-302-als/
3. Coya Therapeutics announces positive results from a proof-of-concept academic clinical study for COYA 302 in amyotrophic lateral sclerosis (ALS). News release. Coya Therapeutics. March 21, 2023. Accessed September 22, 2023. https://ir.coyatherapeutics.com/news/news-details/2023/Coya-Therapeutics-Inc.-Announces-Positive-Results-from-a-Proof-of-Concept-Academic-Clinical-Study-for-COYA-302-in-Amyotrophic-Lateral-Sclerosis-ALS/default.aspx