Trethera to Win New US Patent for TRE-515 Chemical Composition

The award will give the experimental therapy 19 more years of market exclusivity

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by Patricia Inacio, PhD |

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The U.S. Patent and Trademark Office will grant Trethera Corp. a new patent covering the composition and chemical structure of TRE-515, an experimental oral therapy being developed for multiple sclerosis (MS) and cancer.

The patent number 11,446,307, titled “Crystalline forms of a deoxycytidine kinase inhibitor and uses thereof,” extends TRE-515’s original patent protection by at least seven years. This grants Trethera market exclusivity for it in the U.S. until November 2041.

“We are extremely pleased with this addition to the TRE-515 patent portfolio,” Ken Schultz, MD, Trethera’s CEO and patent co-inventor, said in a company press release. “The patent issue is significant, not only by adding more than 19 years of exclusivity from today in the world’s largest market, but also encompassing claims that cover TRE-515’s unique chemical structure, whether used in the treatment of cancer, multiple sclerosis, or other diseases.”

According to Trethera, similar patent applications are being submitted in other markets, including Europe and Japan.

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TRE-515 is a first-in-class small molecule designed to potently block deoxycytidine kinase (dCK), an essential enzyme in a metabolic pathway that recycles products of DNA degradation. This pathway is involved in T-cell and B-cell development, two immune cell types that contribute to the abnormal inflammatory responses in MS.

Preclinical studies in two mouse models of MS showed that starting treatment with TRE-515 immediately after disease induction significantly delayed the onset of symptoms and eased disease severity in both mouse models, compared with untreated mice.

Similar results were seen in one of the models wherein TRE-515 was initiated only after symptoms became evident, which better mimics the treatment scenario in people with MS.

In both approaches, mice also had fewer infiltrating immune cells in the central nervous system (the brain and spinal cord) and reduced myelin loss (demyelination), the hallmark of MS.

TRE-515 was recently granted orphan drug status for demyelinating optic neuritis, which is marked by inflammation in the optic nerves that send visual information from the eyes to the brain.

“Succeeding in this patent application demonstrates Trethera’s strong overall commitment to protecting the innovation and commercialization of our lead asset,” Schultz said.

dCK is also implicated in cancer cell growth and Trethera is investigating its inhibitor in a Phase 1 clinical trial (NCT05055609) involving people with solid tumors. The study is enrolling patients with advanced cancers for whom no therapies exist or are no longer effective.

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