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Thiogenesis Announces Positive Results from Phase 1 Dose-Escalation Study of its Lead Compound TTI-0102
Data demonstrates potential for less frequent drug administration TTI-0102 was well tole...
About this update from Thiogenesis Therapeutics Corp
[{"type":"text","content":"Thiogenesis Announces Positive Results from Phase 1 Dose-Escalation Study of its Lead Compound TTI-0102Data demonstrates potential for less frequent drug administrationTTI-0102 was well tolerated with no Serious Adverse Events reportedSupports EU and US regulatory submissions for human efficacy trials in multiple disease indicationsSan Diego, California--(Newsfile Corp. - May 18, 2022) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (\"Thiogenesis\" or the \"Company\") a clinical-stage biotechnology company developing sulfur-containing therapeutics for serious pediatric diseases, today announces positive results from its Phase 1 clinical study of oral TTI-0102 in healthy volunteers in Australia.The Phase 1, \"Open-Label, Dose-Escalation Study - to Evaluate Safety, Tolerability and Pharmacokinetics of Oral TTI-0102 Compared to Cystagon® (cysteamine bitartrate) in Healthy Volunteers,\" demonstrated that TTI-0102, which acts as a precursor to the thiol-active compound cysteamine, was safe and well tolerated at dose levels ranging from 600 mg cysteamine-base equivalent to 2400 mg cysteamine-base equivalent with no serious adverse events. The pharmacokinetic (PK) profile suggests the potential for once-a-day dosing at target therapeutic levels compared to four times a day dosing with Cystagon®.The results from this study will be used to support Thiogenesis' Investigational Medicinal Product Dossier (IMPD) submission in Europe and its Investigational New Drug (IND) submissions in the US for human efficacy trials in multiple disease indications.\"We are very encouraged with the results of our Phase 1 study exhibiting no serious adverse events for TTI-0102, even at the maximum dosage,\" said Patrice Rioux, M.D., Thiogenesis' Founder and Chief Executive Officer. \"Cysteamine has been studied as a compound with significant promise in a number of indications over several decades, however, its development has been constrained due to its dose-limiting side effects, most notably nausea.\"Dr. Rioux continued, \"These PK results demonstrate that TTI-0102 can significantly increase dosing and achieve a higher blood level \"area under the curve\" (AUC) of the active compound, without increasing its peak concentration or Cmax. The peak Cmax of cysteamine is typically correlated with the timing of its debilitating side effects. With this pr...