Coya, Dr. Reddy’s collaborate to advance COYA 302 for ALS

Deal gives Dr. Reddy's exclusive marketing rights in North America, Europe

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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Under a new agreement, Coya Therapeutics’ amyotrophic lateral sclerosis (ALS) treatment candidate COYA 302 — which aims to suppress chronic and sustained inflammation — will now be exclusively marketed by Dr. Reddy’s Laboratories in the U.S., Canada, and the U.K., as well as in the European Union, should it be approved in those countries.

Coya will retain the rights to market COYA 302 in Japan, Mexico, and countries of South America. Additionally, the company will remain responsible for moving the experimental therapy through clinical development in the U.S. and dealing with regulatory matters.

The company is preparing a meeting with the U.S. Food and Drug Administration (FDA) to discuss its development plans for COYA 302 in advance of an investigational new drug (IND) application, which it plans to file in early 2024. That IND will seek FDA clearance to launch a Phase 2 clinical study of the combination therapy.

Under the terms of the agreement, India-based Dr. Reddy’s will make an upfront payment of $7.5 million. Additional payments of up to $40 million will follow should a number of development and regulatory milestones be achieved. Coya also could receive additional payments of up to $677.25 million based on sales milestones, as well as royalties on net sales.

“While the agreement provides the financial resources to execute on the Phase 2 clinical program for COYA 302 in ALS, the strategic value of the partnership contributes much more than capital,” Howard Berman, PhD, Coya’s CEO, said in a press release.

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This agreement comes in addition to an in-licensing agreement signed earlier this year, in which Dr. Reddy’s has allowed Coya to use its proposed biosimilar of abatacept — a fusion protein — as one of the components in COYA 302.

“We will benefit from and leverage Dr. Reddy’s manufacturing expertise and growing commercial infrastructure both in the USA and worldwide as we plan together for the future of COYA 302 in ALS,” Berman said.

ALS occurs due to damage to motor neurons, the nerve cells in the brain and spinal cord that control movement. The exact mechanisms leading to nerve cell damage in ALS are unclear, but an overly active immune system is believed to play a role.

COYA 302 contains a combination of low-dose interleukin-2 (IL-2), a signaling molecule that’s intended to increase the activity of anti-inflammatory immune cells called regulatory T-cells (Tregs), and a fusion protein known as CTLA4-Ig or abatacept. Abatacept is designed to decrease the activity of immune cells that promote inflammation and damage in ALS.

The combination therapy is given via a subcutaneous, or under-the-skin, injection.

We will benefit from and leverage Dr. Reddy’s manufacturing expertise and growing commercial infrastructure both in the USA and worldwide as we plan together for the future of COYA 302 in ALS.

A small proof-of-concept trial tested the therapy in four people with ALS, who received treatment at the Houston Methodist Research Institute, in Texas, for 48 weeks, or about 11 months.

The results showed a marked slowing in disease progression, with patients experiencing less than a 2-point decline in ALS Functional Rating Scale (ALSFRS-R) scores over the 11 months. That was in comparison to a 1.1 monthly decline before entering the study.

COYA 302 also increased the activity of regulatory T-cells while leading to a reduction in markers of inflammation and oxidative stress — a type of cell damage caused by excessive inflammation. The treatment was well tolerated, with the most common side effect being mild reactions at the site of injection.

“Patients with ALS, commonly known as Lou Gehrig’s disease, have very few treatment options,” said Marc Kikuchi, CEO at Dr. Reddy’s North America.

“We are pleased to partner with Coya Therapeutics on this investigational therapy which may have a unique place in treating patients with this progressive neurodegenerative disease,” Kikuchi said.