Tenax Therapeutics received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a novel formulation of imatinib mesylate for the treatment of pulmonary arterial hypertension (PAH), according to a press release from the company.
Tenax now plans to start a comparative pharmacokinetic study of the new formulation, which the company hopes to complete by the end of the year. Following this, a single phase 3 study is planned for the second quarter of 2022 to further assess the new delayed-release formulation.
The chief executive officer of Tenax, Christopher Giordano, said in the press release, “Tenax is thrilled we can now advance our imatinib PAH program towards pivotal testing.”
The company had already shown in a phase 3 clinical trial that imatinib mesylate improved exercise capacity and hemodynamics in patients with advanced PAH when used as an add-on therapy. However, the treatment led to adverse effects such as nausea and vomiting, which resulted in excessive dropouts from the study and the subsequent termination of the program. The new formulation specifically addresses the gastric intolerance associated with the treatment.
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“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,” Giordano stated.
Stuart Rich, MD, the chief medical officer of Tenax added, “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.”
Imatinib mesylate is a tyrosine kinase inhibitor that has been demonstrated to block several growth factors that regulate endothelial and vascular smooth muscle cell proliferation in PAH.
Tenax Therapeutics announces clearance of the Investigational New Drug application for imatinib in pulmonary arterial hypertension (PAH). News release. Tenax Therapeutics; October 6, 2021.