By David Willey, Benzinga

Coya Therapeutics (NASDAQ: COYA) has just reported proof of concept data from its trial for COYA 302, a new combination drug for treating amyotrophic lateral sclerosis (ALS). The results for this novel biologic were positive, showing a slowing or even halting of ALS’ progression. There is currently no drug on the market that can halt ALS progression.

The global market for ALS treatment was worth $613 million in 2022 and is expected to reach $1.03 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.3% during the forecast period. There is no known cure for ALS, and the increasing awareness of the disease raised by healthcare and advocacy organizations is partly behind the current market growth. Also known as Lou Gehrig’s disease, ALS can either be hereditary or individual. While it is most associated with aging, certain unhealthy environments and lifestyles could also factor in increasing rates of ALS incidence.

ALS is a disease that attacks the brain and spinal column, destroying the motor neurons and causing the degeneration of the nervous system. It usually starts at the extremities like the hands or feet, and as it spreads the patient loses control of their muscles, normally dying from respiratory failure within three to five years. Familial or hereditary ALS only accounts for 5-10% of all ALS patients, and the cause of ALS in sporadic patients, up to 95%, is still unknown.

Drugs that are currently on the market, such as Radicava (Edaravone) or Amylyx’s Relyvrio, may slow but do not stop the disease. Recent research suggests that perhaps the best way to tackle ALS is through immunomodulatory therapy that targets motor neuron disease by attacking inflammatory and oxidative stress pathways, which are thought to be contributing to neuronal dysfunction. This is Coya Therapeutics’s approach with its biologic, COYA 302.

Through the data that Coya has collected in its proof of concept study, it believes COYA 302 can control or even possibly even prevent ALS decline. COYA 302 is an investigational combination biologic administered subcutaneously, and it is a combination of COYA 301 (low dose IL-2) and CTLA4-Ig fusion protein. The drug’s dual action controls both inflammation and oxidative stress in the blood. It supports the regulatory T-cells (Treg), which control the immune system’s inflammatory response, and downregulates effector cells, proinflammatory cells, and lipid peroxides.

Over the clinical trial’s 48-week period, the drug was tested on four patients for safety, tolerability, the function of Tregs, certain biomarkers, and also for preliminary efficacy. At 24 weeks, there was significant Treg enhancement, and at 48 weeks the serum biomarkers for inflammation and oxidative stress were lowered. Throughout the treatment, the patients did not appear to suffer any serious adverse effects.

COYA 302’s preliminary efficacy was measured using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), a validated rating tool that monitors the disability progression in ALS patients. The mean (±SD) ALSFRS-R scores were 33.75 ±3.3 at week 24 and 32 ±7.8 at week 48, not statistically different from the ALSFRS-R score at baseline (33.5 ±5.9) before COYA 302 treatment. In other words, the data suggests a significant improvement in the progression of the disease over the 48-week treatment period, validating Coya’s approach with its new biologic.

“We believe the results of this initial proof-of-concept study in a small number of ALS patients are encouraging and warrant conducting a larger and controlled industry-sponsored study. ALS continues to be a disease of high unmet need and we are committed to develop COYA 302 as safely and as expeditiously as possible, in compliance with current regulations,” said Adrian Hepner, M.D., Coya’s Chief Medical Officer. “We plan to file an IND with the FDA in the second half of 2023 and initiate a clinical study soon thereafter.”

Want to learn more about Coya Therapeutics and what it’s doing to treat ALS? Visit its website.

This article was originally published on Benzinga here.

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 a 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.

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David S. Snyder

David@coyatherapeutics.com

https://coyatherapeutics.com/