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Thiogenesis Advances Cystinosis Program With New Study and Phase 3 Plans for TTI-0102

Story Highlights
  • Thiogenesis launches an investigator-led study of TTI-0102 in cystinosis patients to refine dosing and assess tolerability.
  • The company prepares a new TTI-0102 salt formulation and plans a Phase 3 non-inferiority trial under FDA’s 505(b)(2) pathway.
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Thiogenesis Advances Cystinosis Program With New Study and Phase 3 Plans for TTI-0102

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An announcement from Thiogenesis Therapeutics Corp ( (TSE:TTI) ) is now available.

Thiogenesis Therapeutics has initiated an investigator-initiated study collaboration with leading cystinosis expert Dr. Larry Greenbaum at Emory University and Children’s Healthcare of Atlanta to evaluate its lead candidate TTI-0102 in nephropathic cystinosis patients, focusing on once-daily dosing, tolerability, and white blood cell cystine control to support dose optimization and inform a planned Phase 3 pivotal program. The company is also advancing a newly patented salt formulation of TTI-0102, scaling up manufacturing and conducting stability testing in parallel with finalizing an IND for cystinosis, with the aim of launching a Phase 3 non-inferiority trial against an approved cysteamine therapy under the FDA’s 505(b)(2) pathway, potentially offering a more convenient, better-tolerated treatment that could enhance adherence and quality of life for patients while providing a relatively efficient regulatory route to registration.

More about Thiogenesis Therapeutics Corp

Thiogenesis Therapeutics Corp. is a clinical-stage biotechnology company focused on developing next-generation sulfur-based prodrugs for rare pediatric diseases. Its lead candidate, TTI-0102, is a cysteamine-based disulfide prodrug designed to improve on existing cysteamine therapies for conditions such as nephropathic cystinosis by enabling sustained exposure, once-daily oral dosing, improved tolerability, and potential dual benefits in cystine depletion and intracellular antioxidant pathways.

Average Trading Volume: 23,849

Technical Sentiment Signal: Sell

Current Market Cap: C$31.88M

See more data about TTI stock on TipRanks’ Stock Analysis page.

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