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.”
1 Circulation. 2013;127:1128-1138.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. Tenax is developing a delayed release oral formulation of imatinib, designed to avoid the gastric irritation observed in a previous Phase 3 trial of the marketed version of the therapy, and expects to conduct a single pivotal trial pursuant to the 505(b)(2) pathway for regulatory approval. The Company also owns North American rights to develop and commercialize levosimendan and has recently released detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting, and in the Journal of the American College of Cardiology: Heart Failure. For more information, visit www.tenaxthera.com.
Tenax is developing a novel formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). This unique, delayed release form of oral imatinib has been designed to avoid the gastric intolerance observed in the previous phase 3 clinical trial in patients with PAH. This trial demonstrated that oral imatinib may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, alone or in combination. Despite the availability of several classes of pulmonary vasodilators, no existing treatment has been shown to halt progression or induce regression of the disease. Imatinib acts on underlying cellular proliferative pathways associated with PAH and has the potential to be the first disease modifying therapy for PAH. Tenax intends to commence a phase 3 trial starting in 1H 2022.
Levosimendan is a unique potassium ATP activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Pharma in Finland, intravenous levosimendan is approved in over 60 countries for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize levosimendan. Results of Tenax’s Phase 2 trial of levosimendan in patients with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) demonstrated that levosimendan produces potent dilation of the central and pulmonary venous circulations which translated into an improvement in exercise capacity. Patients are now in an ongoing open-label transition study from weekly IV to a more convenient daily oral regimen. The discovery that venous dilation with levosimendan leads to increased exercise capacity in PH-HFpEF patients forms the basis for the Phase 3 investigation of the oral formulation of this potential groundbreaking therapy. To date, no drug therapy has ever improved exercise tolerance in patients with PH associated with HFpEF, recently referred to as the greatest unmet need in cardiovascular disease.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 31, 2021 and its quarterly report on Form 10-Q filed on August 16, 2021, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.