Tenax Therapeutics has announced that its modified formulation of imatinib mesylate, TNX-201, effectively preserves bioavailability while minimizing gastric release in pulmonary arterial hypertension (PAH).

The pharmacokinetic results, announced via news release, showed that TNX-201 bioavailability significantly exceeded Tenax’s relative bioavailability threshold as compared with Gleevec® tablets as reference.

“Since it has been established that oral imatinib is effective in PAH, our goal has been to modify the dissolution characteristics so as to mitigate the [gastrointestinal] side effects and improve adherence to the effective dose,” Stuart Rich, MD, chief medical officer of Tenax Therapeutics said.


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“We are optimistic that we now have a product that will serve the needs of our patients with PAH better than before.”

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Imatinib has the potential to be a novel disease-modifying therapy for PAH, given its ability to act on the underlying pathways associated with cell proliferation in the disease. Tenax Therapeutic’s previous phase 3 trial, known as the IMPRES trial, showed that oral imatinib can offer a greater and longer treatment effect on tolerance to exercise than any other treatment currently available for PAH.

The current successful results will be further explored in Tenax Therapeutic’s next phase 3 trial, the IMPROVE study, which is currently recruiting clinical sites. Enrollment is expected to begin in the second half of 2022.

Reference

Tenax Therapeutics announces successful comparative pharmacokinetic study of TNX-201 for the treatment of pulmonary arterial hypertension. News release. Tenax Therapeutics; May 23, 2022.