Benzinga | Oct 6, 2021 08:34AM EDT

Tenax Therapeutics Reports Clearance Of Investigational New Drug Application For Imatinib In Pulmonary Arterial Hypertension

Unique, Delayed-Release Formulation of Imatinib Designed to Avoid Gastric Intolerance

On Track to Initiate a Single Phase 3 in PAH in 2Q 2022

Recently Updated Company Website Highlights Imatinib Clinical Program

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced that the FDA has reviewed and cleared its Investigational New Drug (IND) application for a novel formulation of imatinib. Tenax intends to initiate in October, and complete before the end of 2021, a comparative pharmacokinetic (PK) study, bridging to the start of a Phase 3 trial of their delayed-release formulation for the treatment of pulmonary arterial hypertension (PAH).

"Tenax is thrilled we can now advance our imatinib PAH program towards pivotal testing," said Christopher Giordano, Chief Executive Officer of Tenax Therapeutics. "Imatinib has already been clinically proven to be effective in PAH, and with our unique formulation, we anticipate a better tolerated, and thus more effective, treatment option with the potential to advance the current standard of care for patients suffering from this rare and fatal condition." FDA's authorization to proceed is a highlight in what has already been a transformative year for Tenax. Mr. Giordano commented, "We have added incredible talent to the team, while maintaining an aggressive pace of product development, and we remain on track to be the first company to commence a Phase 3 trial of a new formulation of imatinib in patients with PAH."

Tenax will now proceed to enroll patients in a short study comparing the pharmacokinetics of its reformulated imatinib drug candidate with the currently approved oral formulation of imatinib. In a prior Phase 3 study, imatinib mesylate as an add-on therapy was shown to improve exercise capacity and hemodynamics in patients with advanced PAH1. However, excessive dropouts, many from nausea and vomiting due to gastric irritation, led to the program's termination. Tenax has reformulated imatinib to specifically address the gastric intolerance associated with this older, oral formulation. The Company anticipates results from the PK study in the fourth quarter of 2021 and expects to initiate a single Phase 3 study in the second quarter of 2022. A more comprehensive description of the Tenax imatinib program can be found on the company's recently updated website at https://tenaxthera.com/products/#imatinib

"Despite the availability of several vasodilator therapeutics, there remains a serious unmet medical need in PAH to develop new drug therapies with disease-modifying potential for this patient population," said Stuart Rich, M.D., Tenax's Chief Medical Officer. "As a tyrosine kinase inhibitor, imatinib has been shown to block several growth factors that regulate endothelial and vascular smooth muscle cell proliferation in PAH. However, a suboptimal oral formulation of the drug has limited its therapeutic utility in PAH. Tenax' reformulation of imatinib directly addresses this issue. We expect that our formulation will be the first drug therapy to show conclusively a disease modifying impact, due to the inhibition of the pulmonary vascular remodeling seen in PAH."