National Institute of Health to Fund Preclinical Development of Trethera Lead Drug, TRE-515, for Treatment of Crohn’s Disease

LOS ANGELES, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a Small Business Technology Transfer (STTR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) division of the National Institute of Health (NIH). The award provides $400,000 to translate proof-of-principle early research findings of Trethera’s clinical stage first-in-class drug, TRE-515, as an oral therapy for Crohn’s disease.

Crohn’s disease is a chronic, relapsing, inflammatory gastrointestinal disorder that can present with diarrhea, fatigue, severe abdominal pain, and weight loss. Almost 1 million Americans suffer from the disease today, with complications including intestinal fistulas, strictures, and colorectal cancer. Up to a third of patients fail to respond to first line therapy drugs and nearly half lose their drug response within 5 years. Steroids can induce remissions but are less effective at maintaining durability and have significant side effects. The disease is primarily driven by autoreactive CD4 T cells of the patient’s own immune system that target antigens in the gut.  

“A high unmet medical need exists for safe, oral therapies that can be used with first-in-line treatments to help patients maintain disease remission, thereby reducing the need for aggressive broadly immunosuppressive agents.   TRE-515 potentially offers a benefit-risk profile that will be ideally suited for patients with moderate to severe Crohn’s disease seeking a well-tolerated agent to diminish relapses,” said Dr. Ken Schultz, principal investigator and Trethera CEO.

PET scan images showing presence of target enzyme dCK in a normal mouse (left), and one with Crohn’s disease (right).

Figure 1. PET scan images showing presence of target enzyme dCK in a normal mouse (left), and one with Crohn’s disease (right).

“We are very pleased to receive this grant that recognizes the strong therapeutic potential that could be provided for the treatment of Crohn’s disease through a first-in-class drug targeting deoxycytidine kinase (dCK),” said UCLA’s Dr. Peter Clark, member of the Trethera Scientific Advisory Board and grant co-investigator. “The STTR program at NIH plays a vital role in helping companies develop new technologies that serve important U.S. health care needs.”

TRE-515 is an orally delivered, once daily, therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway. A common characteristic of pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division. In contrast, dCK activity is not required in most healthy adult human cells. Mediated by the rate-limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the aberrant activated lymphocytes found in Crohn’s disease to divide, suggesting dCK as a potential therapeutic target with expected enhanced safety.

Sources: NEnglJMed.2020 Dec 31;383(27); Lancet.2017 Apr 29;389; Gastro.2010 Apr138; AmJGastro.2009 Mar;104

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera's innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

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