GT Biopharma announces the successful completion of dosing in its phase 1 clinical trial for GTP-004 that claims to treat Myasthenia gravis. GTP-004 ensures safe administration of pyridostigmine. Doses. Combined doses of pyridostigmine with ondansetron mitigate Gastrointestinal side effects of pyridostigmine thus marking safe dose of it. GT Biopharma is also set to undertake a phase 2 clinical trial in the second half of 2018.
Phase 1 clinical study witnessed five healthy volunteers. Single increasing oral doses of pyridostigmine (ranging from 30 to 120mg) were administered once daily in the morning. Once subjects reached First Intolerable Dose (FID1) as defined by protocol criteria, upward dose acceleration of pyridostigmine stopped and subjects were washed out for 2 to 7 days. Followed by increasing doses of pyridostigmine in combination with ondansetron to subjects who received FID.
The report reveals three subjects (2 males, one female; aged 34 to 43) reached FID with pyridostigmine alone. The dose-limiting gastrointestinal adverse event occurred at 60 mg for 2 subjects and 90 mg for the third subject. When these three subjects received GTP-0004 (pyridostigmine with ondansetron), gastrointestinal adverse events were revoked, and all subjects tolerated doses as high as 120 mg, the maximum allowed dose allowed by the protocol.
GT Biopharma Chief Executive Officer Dr. Kathleen Clarence-Smith said, “These are early results, but the data provide evidence of the ability of GTP-004 to avoid the GI side effects of administering pyridostigmine alone and offer hope to all those suffering from myasthenic syndromes. We expect to be in a position to begin a Phase 2 clinical trial in patients in the second half of 2018.”
Image Source: GT Biopharma