New Data Supports Dalazatide from Kv1.3 Therapeutics as a Potential Therapy for Inclusion Body Myositis (IBM)

Kv1.3 Therapeutics, Inc. (Kv1.3 Therapeutics), a Seattle-based, clinical stage biopharmaceutical company, today announced the presentation of new data from sporadic inclusion body myositis patients (sIBM) at the American Academy of Neurology Meeting that identified high expression of the Kv1.3 ion channel on lymphocytes from skeletal muscle biopsies obtained from patients with this progressive and debilitating degenerative musculoskeletal disorder. Kv1.3 is frequently found on T effector memory cells, a population of immune cells implicated in many T cell mediated autoimmune disorders including rheumatoid arthritis, lupus and multiple sclerosis. Identification of Kv1.3, an important regulator of T effector memory cell activity, on lymphocytes in sIBM patients provides support for the potential treatment of this disease with Kv1.3 Therapeutics's drug therapy, dalazatide, which studies indicate is a highly selective and a near irreversible inhibitor of the Kv1.3 ion channel. The data was presented by Dr. Tahseen Mozaffar, Professor of Neurology at the University of California, Irvine, at the Annual American Academy of Neurology meeting in Los Angeles.

Dr. Mozaffar reported that patients with IBM have high Kv1.3 expression on effector memory T cells in their skeletal muscle biopsy samples. "The abundance of Kv1.3 channels at the site of both active inflammation and where we also observe the hallmark markers of sIBM muscle damage and destruction provides us with a compelling hypothesis to evaluate the impact of targeting these cells. Dalazatide has demonstrated pre-clinical activity in multiple pre-clinical animal models of T cell autoimmune disease and has been found to be safe in early clinical trials," said Dr. Mozaffar, the lead investigator on this research. "We look forward to clinical trials of dalazatide in sIBM patients."

"Kv1.3 Therapeutics is preparing for Phase II clinical studies of dalatatide in the sIBM setting," said Craig W. Philips, Chief Executive Officer of Kv 1.3 Therapeutics. "We've also engaged BTIG to assist us with evaluating strategic opportunities to accelerate the development of dalazatide in sIBM and other T cell autoimmune disorders with high un-met medical needs."

IBM is a degenerative autoimmune disease which is estimated to affect over 16,000 people in the US. The number of people affected by this disease is expected to increase over the next decades with some estimates suggesting that it will double by 2030. Currently, no drugs are FDA approved for this disease and patient management is primarily focused on supportive care.

Link to Poster Kv1.3 Expression on Effector Memory T-Cells in Sporadic Inclusion Body Myositis: Potential for Targeted Immunotherapy with Dalazatide. Tahseen Mozaffar MD, Marie Wencel BS, Namita A. Goyal MD, Craig W Philips* BSc, MBA, Chelsea Olsen* PhD,Karissa Munoz BS, Ali Mannaa, Armando Villalta PhD. University of California, Irvine, CA and *Kv1.3 Therapeutics, Inc., Seattle WA.

Link to Abstract (#437 Session P3, American Academy of Neurology).

About Dalazatide

Dalazatide is a novel Kv1.3 blocker, a first-in-class drug being developed initially for rare autoimmune diseases including as a potential treatment of myositis - a rare autoimmune disease with significant unmet medical need. Dalazatide is the lead drug in Kv1.3 Therapeutics's patent-protected family of Kv1.3 blockers and has demonstrated activity in a variety of autoimmune disease models and a proof-of-concept prototypical autoimmune disease Phase 1b clinical trial. In addition to showing clinical activity in an autoimmune patient population, additional studies have also reinforced the immune sparing features of this drug. Kv1.3 Therapeutics's products provide potentially breakthrough solutions in the toolkit for physicians managing patients with certain rare and debilitating autoimmune diseases.

About Kv1.3 Therapeutics, Inc.

Kv1.3 Therapeutics is a Seattle-based, clinical stage biopharmaceutical company. The company is committed to transforming treatment alternatives for patients with rare and autoimmune diseases. The company is focused on developing a unique group of Kv1.3 blockers for potential management of rare diseases such as myositis, a rare and debilitating disease which affects over 16,000 Americans. Kv1.3 Therapeutics actively collaborates with private, academic and industry partners to advance research and clinical activities in rare diseases. 

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