GT Biopharma Inc. (GTBP) Starts FDA Phase 1 Clinical Trial for Myasthenia Gravis Autoimmune Muscular Disease

The treatment of myasthenia gravis involves treatment of the muscular weakness by acetylcholinesterase inhibitors that do not cross the blood-brain barrier and by immunotherapy to slow disease progression (Gotterer and Li, 2016).

Only two drugs – pyridostigmine and neostigmine – are approved for the treatment of the symptoms of myasthenia gravis. Both inhibit an enzyme called acetylcholine esterase. These drugs cause considerable improvement in muscular strength in some patients and little to none in others (Howard, 2015). Strength rarely returns to normal. Both drugs carry the risk of gastro-intestinal side effects, limiting their achievable efficacy. In the U.S., pyridosgimine is the drug most often prescribed. GTP-004 combines pyridostigmine with another approved treatment. The goal is to reduce gastro-intestinal side effects to allow for the fully efficacious dose of pyridostigmine to be safely used. The objective of the Phase I clinical trial is to demonstrate that with GTP-004 gastro-intestinal side effects are safely reduced.

GT Biopharma Chief Executive Officer, Dr. Kathleen Clarence-Smith, said, “I am very pleased that GT Biopharma’s first clinical trial in patients with myasthenia gravis has started and I have high hopes that the GTP-004 drug will bring substantial help to patients. The start of this trial underscores our commitment to patients with neurological disease.”

GT Biopharma Executive Chairman Anthony J. Cataldo said, “We continue to move our product portfolio forward with major milestones. The start of our clinical trial of GTP-004 (for Myasthenia Gravis) represents another biotech asset that we believe could bring significant value to our shareholders.”

GT Biopharma CMO, Dr. Raymond Urbanski said, “This represents not only another significant step for GT Biopharma but also for the thousands of patients that suffer with this often debilitating disease.”

About GT Biopharma, Inc.: GT Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products as well as central nervous system treatments. GT’s lead oncology drug candidate, OXS-1550 (DT2219ARL) is a novel bispecific scFv recombinant fusion protein-drug conjugate composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a modified form of diphtheria toxin as its cytotoxic drug payload. OXS-1550 targets cancer cells expressing the CD19 receptor or the CD22 receptor or both receptors. When OXS-1550 binds to cancer cells, the cancer cells internalize the drug and are killed due to the action of cytotoxic payload. OXS-1550 has demonstrated encouraging results in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. OXS-3550 TriKE technology was developed by researchers at the University of Minnesota Masonic Cancer Center. As demonstrated in non-clinical models, this targeted immunotherapy directs immune cells to kill cancer cells while diminishing drug-related toxicity. GT’s CNS platform is focused on acquiring or discovering and patenting late-stage, de-risked, and close-to-market improved treatments for CNS disease (Neurology and Pain) and shepherding them through the approval process to the NDA. The Company’s neurology products currently include PainBrake, as well as treatments for the symptoms of myasthenia gravis and motion sickness.

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