Connect with us

Hi, what are you looking for?

Tech & Science

ALS drug failures and why COYA 302 is different

ALS, which is also known as Lou Gehrig’s Disease, is a rare neurological disease that affects motor neurons — the nerve cells.

Scientists using laboratory instruments. — Image by © Tim Sandle
Scientists using laboratory instruments. — Image by © Tim Sandle

Why are so many amyotrophic lateral sclerosis (ALS) drug trials are failing? And what makes a new candidate drug called COYA 302, an investigational therapy for ALS, different? COYA 302 is a dual-mechanism investigational biologic combination therapy. 

To explore this area, Digital Journal spoke with Milan Kalawadia, CEO, North America of Dr. Reddy’s Laboratories (RDY), and Arun Swaminathan, CEO of Coya Therapeutics (COYA).

The two companies have a strong collaboration for the development and commercialization of COYA 302.  Kalawadia and Swaminathan expand on their partnership and discuss why Coya’s approach to enhancing regulatory T cell (Treg) function and the use of combination biologics is different and important to combatting neurodegenerative diseases. This is similar to how we fight HIV and cancer.

Digital Journal: Can you provide a brief background on Dr. Reddy’s Laboratories and Coya Therapeutics?

Kalawadia: Established in 1984, Dr. Reddy’s Laboratories is a global pharmaceutical company headquartered in Hyderabad, India, with US headquarters in Princeton, New Jersey. The company provides access to affordable and innovative medicines, offering a portfolio of products and services including Active Pharmaceutical Ingredients (APIs), generics, branded generics, injectable products for use in hospitals and institutions, biosimilars, as well as private label and other over-the-counter (OTC) medications.

Swaminathan: Coya Therapeutics, founded in 2020, is a clinical-stage biotechnology company headquartered in Houston, Texas. The company develops proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Coya Therapeutics believes combinations are the future of treatment approaches in neurodegenerative diseases and is building a pipeline around COYA 302, the combination of its proprietary low-dose interleukin-2 (COYA 301 or LD IL-2) and CTLA4-Ig.

DJ: Why did Dr. Reddy’s Laboratories partner with Coya Therapeutics for the development and commercialization of COYA 302?

Kalawadia: Dr. Reddy’s is a firm believer in the importance of deep science, and this belief has led to many innovations. As part of our pathway, we are continuing to plan and invest in the businesses of the future. For this reason, we partnered with Coya Therapeutics for the development and commercialization of COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS). ALS, which is 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. We feel that patients with ALS have extremely limited options for treatment and believe in the potential of COYA 302. This is part of our biologics/biosimilars focus, which is expected to drive near-term and long-term growth. We hope it will help to reach our goal of serving over 1.5 billion patients by 2030.

DJ: How does Coya Therapeutics fit into Dr. Reddy’s Laboratories overall strategy?

Kalawadia: Dr. Reddy’s is committed to expanding our footprint in biologics and biosimilars. We have recently concluded multiple transactions that strengthen our biosimilar portfolio. COYA 302 utilizes our potential abatacept biosimilar in combination with a low-dose IL-2. Coya Therapeutics has advanced this innovative combination for indications like ALS. This fits right in with our’ vision to expand into innovative therapies. This is a truly synergistic partnership that is beneficial for both companies and most important, could bring additional options to patients with ALS.

DJ: Why are so many ALS drug trials failing and what makes COYA 302 different?

Swaminathan: ALS is an extremely heterogenous disease with many different pathogenic mechanisms contributing to its progression. It is likely that different pathogenic mechanisms are relevant only in subsets of patients with ALS. Currently, there are no methods to screen patients for underlying mechanisms that are important in each individual patient. Most drugs fail because they target mechanisms that are likely only playing roles in subsets of patients and the beneficial effects in these subsets of patients may be washed out when all patients are included in the larger trials.

Also, clinical trial designs may not be optimal in ALS, and they may require longer times to observe beneficial effects and better use of biomarkers to understand targeted drug effects.

Neuroinflammation is a common mechanism in people with ALS. As Treg function declines in ALS, the disease progresses more rapidly. Combination approaches that enhance Tregs and suppress neuroinflammation have the potential to slow motor neuron degeneration and stabilize the progression.

Many different types of drugs have unfortunately failed including Relyvrio and Verdiperstat (drugs targeting inflammation). We believe we have a mechanism that not only targets the body’s inflammatory response that contributes to neuronal degeneration, but also enhances Treg numbers and function which has the potential to slow disease progression. It is this combination approach that is novel and may start to change the landscape and how ALS is treated.

Antisense oligonucleotide therapies, such as Qalsody (tofersen) for variant SOD1-mediated ALS, represent major breakthroughs, but only target a very small percentage of people with ALS. Since decreased Tregs and inflammation have been seen across ALS patients regardless of genotype, COYA 302 has the potential to impact many more patients, and ultimately be used with gene-specific therapies as they emerge.

DJ: What are the next steps for the advancement of COYA 302?

Swaminathan: The first priority is completing the ongoing nonclinical work and submitting the required data necessary to support our Investigational New Drug (IND) filing. We intend to initiate the proposed Phase 2 clinical trial in patients with ALS upon approval of the IND by the FDA.

Once the ALS IND has been accepted, we will submit an IND for the Frontotemporal Dementia (FTD) indication. We will initiate the phase 2 study in patients with FTD upon approval of the IND by the FDA.

DJ: What trends are you watching in the treatment of ALS and neurodegenerative diseases?

Swaminathan: Major trends have to do with clinical trial design and incorporation of biomarkers for screening and as efficacy endpoints. There is movement to utilize the effects on targeted biomarkers in making go/no-go decisions for moving drugs through the clinical trial program. There are many companies in the drug development space for ALS at this time, and several upcoming drugs will be tested that target many different mechanisms that have shown to be relevant in preclinical models of ALS. A combination approach targeting several mechanisms of disease at once may be what is needed to finally slow or even halt the progression of ALS and reach the first goal of making ALS a livable disease.

Avatar photo
Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

You may also like:

Life

Losing weight does not always equate to winning at health. Why is this?

Business

In conversation with Digital Journal at Inventures 2025, Savilow discussed how the carbon-producing industry can go green.

Tech & Science

Measles is an airborne disease (caused by a morbillivirus of the paramyxovirus family) which spreads easily.

Tech & Science

Warning: carbon dioxide and higher temperatures are reshaping how crops grow.