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
Coya Therapeutics has completed a Phase 2 study on low-dose Interleukin-2 (LD IL-2) for mild-to-moderate Alzheimer's disease (AD). The double-blind, placebo-controlled study involved 38 patients over 30 weeks and was funded by the Gates Foundation and Alzheimer’s Association. The study aims to assess the safety, tolerability, and biological activity of LD IL-2. Preliminary data showed significant improvements in cognitive function and Treg cell activity in an earlier open-label study. Topline results are expected in summer 2024. The study was led by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital.
- Completion of Phase 2 study on schedule.
- Study funded by the Gates Foundation and Alzheimer’s Association, indicating strong support.
- Topline results expected by summer 2024.
- Preliminary data showed significant improvements in cognitive function.
- Significant enhancement in regulatory T cell (Treg) function and numbers.
- No serious adverse events reported in preliminary studies.
- No patient discontinued the study.
- Study involved a small number of participants (38 patients).
- Results from Phase 2 not yet available; uncertainty remains.
- Previous studies were open-label with only 8 patients, limiting generalizability.
Insights
This Phase 2 study targeting Alzheimer's disease (AD) with Low Dose Interleukin-2 (LD IL-2) therapy, supported by notable organizations like the Gates Foundation and Alzheimer’s Association, is indeed promising. It builds upon earlier open-label studies that exhibited statistically significant improvements in cognitive functions and Treg function.
LD IL-2 is a biologic agent that aims to enhance the population and functionality of regulatory T cells (Tregs), which play a important role in immunological regulation. This is particularly relevant as neuroinflammation is a critical aspect of Alzheimer’s pathology. By potentially increasing Treg activity, LD IL-2 could mitigate inflammation-related neural damage.
Given the completion of a larger and more rigorous double-blind, placebo-controlled Phase 2 study, the topline results expected in summer 2024 will provide more robust data on safety and efficacy. The therapeutic efficacy suggested by initial smaller studies offers hope for a breakthrough. However, it's important to be cautious as early-stage success does not always translate to later-stage trial outcomes. Investors should note that while preliminary data is encouraging, definitive conclusions can only be drawn post the larger study outcomes.
The completion of the Phase 2 study for Coya Therapeutics is a notable milestone. Coya, listed on NASDAQ under the ticker COYA, is still in its clinical stage and this news could positively impact investor sentiment leading to potential stock price movements. Funding from highly reputable organizations like the Gates Foundation adds credibility and financial stability for future research endeavors.
Investors should be mindful of the timeline: with top-line results anticipated in summer 2024, short-term price volatility is possible. Investors should also consider the inherent risks of biotech stocks, where outcomes of clinical trials can significantly influence financial performance. Successful Phase 2 results could lead to partnerships, acquisitions, or further funding opportunities, while adverse results may have the opposite effect.
In the broader sector, this news aligns with an ongoing trend of significant investments into AD research, driven by the high unmet medical need and substantial market potential. Given the context, the financial implications will heavily depend on the final study outcomes and subsequent regulatory milestones.
From a market standpoint, Alzheimer’s disease represents a large and unmet need within the healthcare industry, providing substantial commercial opportunity for effective treatments. The global Alzheimer’s therapeutics market was valued at
The progression of Coya Therapeutics' LD IL-2 therapy into Phase 2, if successful, positions the company within a lucrative market segment. It is important to monitor how this therapy differentiates from existing treatments, essentially focusing on its novel mechanism of action targeting Treg cells to combat neuroinflammation.
Should the Phase 2 results be positive, it could position Coya as a key player in the Alzheimer’s therapeutics market, potentially leading to strategic partnerships or licensing deals. The company's ability to effectively market and scale production post-approval will be critical for capturing market share.
This investigator-initiated, double-blind, placebo-controlled study (funded by the Gates Foundation and Alzheimer’s Association) evaluates the safety and tolerability, biological activity, and preliminary efficacy of LD IL-2 in 38 patients with mild-to-moderate Alzheimer’s disease (AD) over 30 weeks
Previously reported data from an open-label, proof-of-concept study in eight AD patients illustrated that treatment with LD IL-2 resulted in a statistically significant improvement in cognitive function relative to baseline and significant enhancement of Regulatory T cell (Treg) function and numbers
Phase 2 top line data on track to be reported in summer of 2024
This controlled Phase 2 study will evaluate the safety, tolerability, and biological activity of LD IL-2 in patients with AD compared to placebo at pre-specified intervals. Additionally, blood and cerebrospinal fluid biomarkers, neuroimaging results, and changes in cognitive function will be evaluated across the different patient populations.
Fred Grossman D.O., President and CMO of Coya Therapeutics, stated, “This is an important study that will help advance our expanding pipeline in dementia. We look forward to unblinding the data from this controlled study in Alzheimer’s Disease and releasing the top-line results this summer.”
In the study, a total of 38 patients were randomly assigned to receive commercial subcutaneous LD IL-2 at two different dosing regimens, or matching placebo, over 21 weeks followed by a 9-week follow-up period after the last dose. The first patient cohort was randomized to receive LD IL-2 for five consecutive days every four weeks and the second cohort was randomized to receive LD IL-2 for five consecutive days every two weeks.
Coya previously reported that treatment with LD IL-2 significantly expanded Treg population and function in an open-label proof-of concept study in eight patients with AD. The mean (SD) percentage of Tregs significantly increased from 4.55 (1.97) at baseline to 8.68 (2.99) [p=0.0004] at the end of treatment. Mean (SD) Treg suppressive function significantly increased from
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.
Overall, administration of LD IL-2 appeared to be well tolerated in the eight patients in the open-label, proof-of concept study. The most common adverse events were mild injection-site reactions and mild leukopenia. No serious adverse events were reported, and no patient discontinued the study.
About Alzheimer’s Disease
Alzheimer's disease is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer's disease accounts for up to
References
- Alzheimer’s Association (www.alz.org).
- Centers for Disease Control and Prevention (www.cdc.gov).
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, FTD, and 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 (
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 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
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 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 enhances the number and anti-inflammatory function of Tregs and simultaneously lowers 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
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Source: Coya Therapeutics, Inc.
FAQ
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