Coya Therapeutics, Inc., based in Houston, announced a licencing agreement with Dr. Reddy’s Laboratories, Ltd. on Monday to develop and commercialise COYA 302 for the treatment of neurodegenerative diseases. Coya will pay a one-time non-refundable upfront fee to Dr Reddy’s as part of the agreement, as well as tiered milestone payments to the company. Coya will, however, retain exclusive rights to develop and commercialise COYA 302 in a number of territories, including North and South America, the EU, the United Kingdom, and Japan. Meanwhile, Dr. Reddy’s will have exclusive commercialization rights for COYA 302 in areas outside of Coya’s territory. Coya will pay Dr. Reddy’s tiered royalties on net sales in its licenced territory.
Coya anticipates filing an IND for COYA 302 in the second half of 2023, with the goal of launching a phase 1b/2 trial in ALS shortly after. The agreement also calls for Coya 301, Coya’s low-dose IL-2, to be licenced to Dr. Reddy’s for the commercialization of COYA 302 in territories not previously granted to Coya. Coya will be paid royalties on Dr. Reddy’s net sales in their respective territories. Finally, the companies have the option of entering into a mutually beneficial commercial supply agreement at a later date.
“This is a watershed moment for Coya in our efforts to develop COYA 302. Every emerging biotechnology company strives to partner with a high-caliber pharmaceutical company like Dr. Reddy’s, and we believe that the combined resources of both organisations strengthen our chances of bringing this therapeutic modality to patients with neurodegenerative diseases if approved by regulatory authorities,” said Howard H Berman, Ph.D., CEO of Coya Therapeutics.
“We believe that the COYA 302 proof-of-concept clinical data in ALS patients is encouraging and sets the foundation to advance our development programme,” said Coya’s CMO. Our combination therapy strategy is intended to address the multiple pathophysiological pathways that lead to chronic and sustained inflammation, which drives the progression of serious neurodegenerative diseases. We intend to file an IND in the second half of this year and will work closely with regulatory authorities to begin clinical trials as soon as possible.”