Business
Tenax Therapeutics Announces Successful Comparative Pharmacokinetic Study of TNX-201 for the Treatment of Pulmonary Arterial Hypertension
TNX-201 (oral imatinib modified release tablets) Formulation Development has been Successfully Completed Manufacturing Underway to Support Phase 3 PAH Study
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":"\nTNX-201 (oral imatinib modified release tablets) Formulation Development has been Successfully Completed\n\nManufacturing Underway to Support Phase 3 PAH Study (IMPROVE)\n\n MORRISVILLE, N.C.--(BUSINESS WIRE)--\nTenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the successful completion of its comparative pharmacokinetic study of TNX-201, for the treatment of pulmonary arterial hypertension (“PAH”).\n\nTenax Therapeutics’ efforts to optimize its formulation of imatinib mesylate, TNX-201, have culminated in a modified release tablet that effectively minimizes gastric release while preserving bioavailability. The pharmacokinetic data from this trial showed that TNX-201 significantly exceeded Tenax’ relative bioavailability threshold (area under the curve (AUC)) when compared to reference Gleevec® tablets. These pharmacokinetic results are consistent with earlier in vitro dissolution data that indicated the formulation should limit gastric release while optimizing intestinal absorption.\n\n“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 GI side effects and improve adherence to the effective dose,” said Stuart Rich MD, Chief Medical Officer of Tenax Therapeutics. “We are optimistic that we now have a product that will serve the needs of our patients with PAH better than before.”\n\nBased on these positive pharmacokinetic findings, Tenax Therapeutics and its formulation partner are now manufacturing TNX-201 at the target scale for both the Phase 3 trial and future market demand.\n\n“We believe that the TNX-201 modified release formulation will optimize imatinib blood levels while limiting gastric release and related gastric side effects for patients receiving TNX-201 in our Phase 3 trial,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “Having determined the formulation and moved into the site selection stage of IMPROVE, we are closer than ever to unlocking imatinib’s potential to change the lives of patients with PAH.”\n\nIMPROVE is the Phase 3 clinical trial of imatinib for PAH sponsored by Tenax Therapeutics...