Coya Therapeutics is expanding its development plans to study the company’s lead combination therapy COYA-302 in frontotemporal dementia and Parkinson’s disease in addition to amyotrophic lateral sclerosis (ALS)

This follows the announcement of successful pre-IND and Type C meetings between Coya and the US Food and Drug Administration (FDA) earlier this month about the candidate.

The company plans to file an IND for developing the drug in frontotemporal dementia in Q2 2024 and start a Phase II study the same quarter. The plans for studying COYA-302 in Parkinson’s will follow later, with an IND filing and a Phase I/II start proposed in 2025.

In a deal worth up to $677.25m, Dr Reddy’s Laboratories had signed a licence agreement with Coya in December to develop and commercialise COYA 302 to treat ALS in the European Union (EU), the UK, the US and Canada. Under the terms of the agreement, Coya can earn milestone payments based on future potential sales.

COYA 302, a combination drug made up of COYA 301—a low dose interleukin 2 (IL-2) drug, and a CTLA4 Ig fusion protein, is said to enhance regulatory T cell (Treg) function and expand Treg numbers, which could suppress inflammation in diseases.

The Nasdaq-listed company had closed a $26.5m funding private placement raise in December last year. This influx of funds along with the collaboration with Dr Reddys is meant to support the outfit’s cashflow into 2026. Following the funding, notably, Coya’s Board inducted the former US Secretary of Commerce Wilbur Ross.

In a Phase I clinical study involving four ALS patients over a 12-month period, there was no decline or minimal decline at 24 and 48 weeks post-treatment initiation in a group of patients who had previously experienced decline. In the same study, COYA 302 demonstrated improved Treg suppressive function at both 24 and 48 weeks and effectively lowered serum biomarkers associated with inflammation and oxidative stress. Encouraged by these outcomes, Coya has announced plans to initiate a new trial of COYA-302 in ALS.

In the announcement accompanying the indication expansion, president and chief medical officer at Coya Fred Grossman said: “ALS, frontotemporal dementia, and Parkinson’s disease are driven by a similar, yet complex, proinflammatory environment that requires targeting more than a single pathway.

“COYA 302 has been designed to target multiple pathways, such as restoring dysfunctional Tregs and inhibiting proinflammatory microglia and macrophages and may have disease modifying potential in these severe diseases with high unmet need.”

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