GLP Toxicology Studies

GLP Toxicology Studies

Details:

Toxicology Studies:

  • Initiation and Scope:
    • Launched Good Laboratory Practice (GLP) toxicology studies to evaluate VE3’s safety profile in compliance with regulatory requirements.
    • Conducted in rodent and non-rodent models to gather comprehensive safety data, addressing potential toxicological risks across species.
  • Key Focus Areas:
    • Dose Range Finding (DRF): Assessed tolerable dose levels in animals to identify a safe therapeutic window.
    • Repeat-Dose Toxicology: Studied the effects of VE3 when administered repeatedly over a defined period to detect cumulative toxicity.
    • Toxicokinetics (TK): Measured drug absorption, distribution, metabolism, and excretion (ADME) to establish systemic exposure levels.
  • Endpoints Evaluated:
    • Monitored key indicators such as body weight, clinical signs, organ function, and histopathology of major organs (e.g., liver, kidney, heart).
    • Measured biomarkers of toxicity to detect any off-target or adverse effects.

Manufacture of GMP-Grade API:

  • API Production:
    • Initiated the production of Good Manufacturing Practice (GMP)-compliant active pharmaceutical ingredient (API) for use in clinical trials.
    • Partnered with certified GMP facilities to ensure high-quality and consistent batch production.
  • Stability Testing:
    • Conducted stability tests to ensure that the API maintains potency, purity, and efficacy under various storage conditions.
    • This data supported regulatory submissions and informed packaging and distribution strategies.
  • Scaling Production:
    • Scaled up manufacturing processes to produce sufficient quantities of VE3 for GLP toxicology studies and subsequent clinical trials.

Achievements:

  1. Regulatory Readiness:
    • Generated critical safety data to support Investigational New Drug (IND) submissions and de-risk clinical trials.
  2. Validated Safety:
    • Demonstrated VE3’s tolerability in both short- and long-term exposure models, supporting its progression to human studies.
  3. Optimized Production:
    • Established a robust, scalable process for producing clinical-grade VE3, ensuring compliance with international quality standards.

Strategic Impact:

The GLP toxicology studies and GMP API manufacturing positioned Theranib to meet regulatory requirements efficiently while building confidence among investors and potential collaborators. This phase ensured a seamless transition from preclinical to clinical development.