Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 in the Treatment of Acute Disseminated Encephalomyelitis

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LOS ANGELES, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515, Tretheras first-in-class drug for the treatment of acute disseminated encephalomyelitis (ADEM).

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Tuesday, August 30, 2022
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Inflammation, ADEM, Cancer, Autoimmune disease, Research, Degenerative disease, Central nervous system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Brain, Deoxycytidine kinase, Cranial nerves, Death, Multiple sclerosis, DCK, Acute disseminated encephalomyelitis, Mouse, Food, DNA, Orphan drug, GLOBE, Company, FDA, ODS, UCLA, COVID-19, Spinal cord, Marketing, Private Securities Litigation Reform Act, Patient, Pharmaceutical industry
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SHERMAN OAKS, CA, US
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TRETHERA CORPORATION
Summary
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  • LOS ANGELES, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515, Tretheras first-in-class drug for the treatment of acute disseminated encephalomyelitis (ADEM).
  • No medications have been specifically approved by the FDA to treat it, said Dr. Peter Clark, a specialist member of the Trethera Scientific Advisory Board.
  • The ODS designation qualifies Trethera for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity.
  • Trethera's innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule twice designated by the FDA as an Orphan Drug.



LOS ANGELES, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515, Trethera’s first-in-class drug for the treatment of acute disseminated encephalomyelitis (ADEM). ADEM is a rare autoimmune disease where patients lose their nerve function and become paralyzed, causing death in some cases.

“The symptoms of ADEM involve a severe bout of inflammation in the central nervous system that can include the brain, spinal cord, and sometimes the optic nerves. The inflammation damages myelin, the protective substance that coats nerve fibers throughout the central nervous system. No medications have been specifically approved by the FDA to treat it,” said Dr. Peter Clark, a specialist member of the Trethera Scientific Advisory Board. “Holding ODS at this early preclinical stage is a mark of distinction and external validation. The ODS designation qualifies Trethera for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity.”

Representative stained spinal cord sections from mice. Arrows point to regions of leukocyte infiltration.
Figure 1: Representative stained spinal cord sections from mice. Arrows point to regions of leukocyte infiltration.

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 taken 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.

For more information, please visit us at trethera.com or e-mail Investor Relations at [email protected].

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as "may," "might," "will," "will likely result," "would," "should," "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "continue," "target" or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.


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