Biotech company Coya Therapeutics has provided an update on its pioneering work to slow the progression of neurodegenerative diseases.
Coya Therapeutics has provided an update on a number of recent developments including its presentation on updated biomarker data in late April 2024 at the 2nd Annual Johnson Center Symposium.
The data revealed that 4-HNE levels were predictive of survival in Amyotrophic Lateral Sclerosis (ALS) patients and are elevated at diagnosis in bulbar vs. limb onset ALS.
The company has also announced the publication of a peer-reviewed manuscript titled in the medical journal Frontiers in Neurology that showed promising results of clinical efficacy and suppression of biomarkers of oxidative stress, neuroinflammation and neuronal degeneration in patients with ALS at 24 weeks.
It has also confirmed that it has expanded the company’s research collaboration with the Houston Methodist Research Institute through a sponsored research agreement covering multiple initiatives, including the advancement of multiple patented modalities of exosomes
Additionally, Coya Therapeutics has expanded its pipeline and intellectual property portfolio with the filing of new U.S. patents for COYA 301 in combination with glucagon-like peptide-1 (GLP-1) receptor agonists.
On August 9, 2024, the FDA provided feedback that additional non-clinical toxicology/pharmacology data must be submitted prior to initiating our planned randomised, double-blind, placebo-controlled Phase 2 study of Coya’s first-in-class biologic combination COYA 302 in patients with ALS.
Coya has stated it intends to discuss the recommendations with the FDA in 4Q 2024 to align on its revised non-clinical package to enable the implementation of the study
“We bolstered our corporate and strategic efforts in the second quarter of 2024 and continue to expect a busy second half of the year with COYA 302, our ‘Pipeline in a Drug.’ The dual mechanism of action of COYA 302, a combination of our proprietary LD IL-2 and CTLA4-Ig, could prove vital to addressing complex neurodegenerative diseases, such as ALS, AD, FTD, and Parkinson’s disease (PD), that plague millions of people worldwide,” stated Howard Berman, Ph.D., Coya’s Chief Executive Officer.
“We believe LD IL-2 enhances and restores Treg function, lowering inflammation, while CTLA4-Ig inhibits other inflammatory cell types that may sustain and create more durable Treg functionality. Together, we believe this novel combination approach could provide a new paradigm of treatment for neurodegenerative diseases.
“In May 2024, we received a $5 million strategic investment by the Alzheimer’s Drug Discovery Foundation (ADDF) that will help fund the development of COYA 302 for the treatment of FTD. The ADDF is aligned with our belief in the value of combination therapies for neurodegenerative diseases. We are evaluating plans for advancing COYA 302 in FTD into clinical trials.”
The company has also confirmed it has received $5.0 million strategic investment by the Alzheimer’s Drug Discovery Foundation (ADDF) to help support the development of COYA 302 for the treatment of Frontotemporal Dementia (FTD), and an additional $3.85 million from the previously announced First Amendment and License Agreement with Dr Reddy’s Laboratories.
The latter has been earmarked for funding the first Phase 2 clinical trial of COYA 302 in ALS in the United States.
“Lastly, in Parkinson’s disease, we anticipate releasing animal model data highlighting the potential therapeutic effects of COYA 302 by the end of the year,” concluded Berman.
“Thus, there are plenty of clinical, preclinical and regulatory milestones left to achieve over the next five months that could lead to increased shareholder value. We believe that commercial partnership and license opportunities for COYA 302 outside of ALS still remain, and our cash balance of $36.6 million as of the end of the second quarter provides us the flexibility to seek the best deal(s) possible for our shareholders. I look forward to sharing additional corporate, clinical, and regulatory progress as warranted.”
