DepYmed Receives Clearance from U.S. Food and Drug Administration to Initiate Phase 1 Clinical Trial for DPM-1003 for the Treatment of Rett Syndrome

DepYmed, Inc. (“DepYmed” or the “Company”) is a clinical-stage pharmaceutical company focused on developing transformative medicines for many poorly treated diseases that may benefit significantly by targeting the protein tyrosine phosphatase (PTP) family of enzymes.

FARMINGDALE, N.Y., March 19, 2024 (GLOBE NEWSWIRE) -- Depymed, Inc. (“DepYmed” or the “Company”) is a clinical-stage pharmaceutical company focused on developing transformative medicines for many poorly treated diseases that may benefit significantly by targeting the protein tyrosine phosphatase (PTP) family of enzymes. Today, DepYmed announces it has received clearance from the U.S. Food and Drug Administration to initiate its phase 1 clinical trial for DPM-1003 for the treatment of Rett Syndrome.

“This is a foundational achievement for DepYmed. It allows us to transition into a clinical-stage company with a transformational new drug candidate that has the possibility to provide significant benefit for patients,” said Andreas Grill, DepYmed’s President and CEO. “As an IND for the first drug of its kind, we believe this milestone opens a pathway to the development of important new treatments for a wide range of diseases where inhibiting PTP enzymes holds promise. This includes Rett Syndrome, cancer, metabolic disease and obesity, and Alzheimer’s Disease. We look forward to beginning to assess the safety and tolerability of DPM-1003 and continue our development of this compound for Rett Syndrome and our other ongoing programs.”

About DPM-1003

Protein tyrosine phosphatases are major players in the control of cell signaling pathways that are disrupted in many diseases, yet to date no drug modulators of these enzymes have been successfully developed. DepYmed is the first company to develop a new class of orally bioavailable drug candidates that act by inhibiting PTP1B, one of the most important PTP drug targets. One of its lead compounds has shown promising efficacy in preclinical models of Rett syndrome, and the Company hopes to initiate a phase 1 clinical trial in 2024. DPM-1003 has been granted Orphan Drug designation by the U.S. Food and Drug Administration and conditionally designated under the FDA’s Rare Pediatric Disease program.

About Rett Syndrome

Rett syndrome is a progressive neurodevelopmental disorder that almost exclusively affects females. Infants with Rett syndrome generally develop normally for 6 to 18 months after birth. At this point, they lose previously acquired skills (developmental regression) such as purposeful hand movements and the ability to communicate. Affected children often develop autistic-like behaviors, breathing irregularities, feeding and swallowing difficulties, growth retardation, and seizures. Most Rett syndrome cases are caused by mutations of the MECP2 gene on the X chromosome and can present with a wide range of disability ranging from mild to severe. The expression of PTP1B, DepYmed’s target in Rett syndrome, is regulated by MECP2; in turn, PTP1B controls important cell functions that are disrupted in the disease.

About DepYmed, Inc.

DepYmed, Inc. is a New York-based rare disease and cancer therapeutic development company that was founded to capitalize on the scientific discoveries of the Tonks lab at Cold Spring Harbor Laboratory in the physiological function of PTP1B and ways to modulate its role in various human diseases. DepYmed is currently developing a new class of potent, orally bioavailable small molecule inhibitors of the enzyme PTP1B as novel therapeutics for Rett Syndrome, different types of cancer, metabolic diseases, obesity, and Alzheimer’s Disease where the PTP1B target has shown promise. In addition, DepYmed has also discovered a novel class of small molecules with copper chelating properties that it is developing as potential therapeutic agents for diseases such as Wilson disease and various cancers. The company is actively developing a deep pipeline of new compounds with broad therapeutic potential in these emerging drug classes in collaboration with Cold Spring Harbor Laboratory. For more information, please visit the Company’s website at: www.depymed.com.

For Media Inquiries please contact:

Jules Abraham
JQA Partners, Inc.
jabraham@jqapartners.com
917-885-7378

DepYmed:
info@depymedinc.com


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