TFA-01 | Nonsteroidal drug development for canine osteoarthritisView development progress
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PRESS RELEASE · Development Update

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TFA-01 Dose-Finding Study Scheduled to Begin October 21, Followed by a Four-Arm Canine Osteoarthritis Trial

Trial supply delivery and on-site procedure review completed; dose selection and comparative evaluation are the next milestones

Chief Technology Officer Vincent Liu at the Shanghai trial facilities to learn about the research environment and review procedures for the planned TFA-01 clinical trial.
Figure 1 | Chief Technology Officer Vincent Liu visits the trial facilities in Shanghai to learn about the research environment and working arrangements and review subsequent trial procedures with the clinical team.

TFA Therapeutics, Inc. has completed delivery of the TFA-01 injectable nanoformulation and coordination with the clinical trial site. Shanghai Pet-Sci is scheduled to begin a dose-finding study on October 21, 2026. This stage aims to identify an effective dose and dosing regimen, after which a four-arm canine osteoarthritis trial will follow to advance TFA-01 clinical development.

The dose-finding results will inform dosing in the subsequent controlled trial. The follow-on study will involve dogs with osteoarthritis and is planned to use placebo and active comparators across four arms:

Study armDrug or intervention
TFA-01 investigational armTFA-01 injectable nanoformulation containing Antcin A
Placebo control armNormal saline
Corticosteroid active-control armDexamethasone
NSAID active-control armA nonsteroidal anti-inflammatory drug (NSAID)

The four-arm study will evaluate TFA-01 efficacy relative to placebo and compare its efficacy and safety with a corticosteroid and a nonsteroidal anti-inflammatory drug. The resulting comparisons with existing treatments will provide data to inform further clinical development and preparation of a regulatory submission.

The injectable nanoformulation used in this study was developed by the Taiwan Animal Vaccine Research Institute and collaborating research teams. TFA Chief Technology Officer Vincent Liu visited Shanghai Pet-Sci to review the trial environment and animal-care arrangements, and to confirm trial procedures and plans for subsequent execution with the clinical team.

Subsequent clinical work will proceed in accordance with applicable Chinese new veterinary drug registration requirements and the Good Clinical Practice for Veterinary Drugs (veterinary GCP), covering dosing, observations and assessments, source-data recording and trial reporting. The program will continue to generate canine osteoarthritis efficacy and safety data to support preparations for a TFA-01 regulatory submission.

TFA-01 injectable nanoformulation developed by the Graduate Institute of Animal Vaccine Technology in Taiwan and collaborating research teams, delivered to Shanghai Pet-Sci.
Figure 2 | The TFA-01 injectable nanoformulation developed by the Graduate Institute of Animal Vaccine Technology in Taiwan and collaborating research teams has been delivered to Shanghai Pet-Sci for the planned canine osteoarthritis clinical trial.

Sources and research references

About TFA

TFA Therapeutics, Inc. (OTCQB: RAJAF) is developing TFA-01, an Antcin A-based drug candidate, with canine osteoarthritis as its initial target indication. The program includes source material and formulation development, as well as safety and efficacy evaluation.

Forward-looking statements: The development plans described in this release may change in response to study results, regulatory requirements, and funding arrangements. Actual progress and outcomes may differ from current expectations.

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