Tenax Therapeutics Prioritizes Development Of TNX-103 For Heart Failure

Tenax Therapeutics Inc TENX has decided to prioritize the Phase 3 testing of TNX-103 (oral levosimendan), with plans to commence a levosimendan Phase 3 study in 2023.
The move is based on a strategic review process that began in September 2022.
The decision to prioritize the clinical development of TNX-103 ahead of imatinib is based on several factors, including a growing intellectual property estate that encompasses the use of levosimendan to treat PH-HFpEF in the U.S.
In March, the United States Patent and Trademark Office (USPTO) granted Tenax a patent for intravenous (IV) levosimendan in patients with PH-HFpEF.
This is the second levosimendan patent granted to the company since early 2022 and provides a strong basis for a potentially successful review of a third patent that will specifically cover claims related to TNX-103 (oral levosimendan), which could be granted in 2023.
Based on an end-of-Phase 2 meeting with the FDA, the agency agreed that one or two Phase 3 clinical studies (depending on the size) with a primary endpoint of change in a 6-minute walk distance over 12 weeks or a single Phase 3 trial with clinical worsening over 24 weeks would be sufficient to demonstrate the effectiveness of levosimendan in PH-HFpEF.
The FDA also agreed to a plan to replace weekly intravenous levosimendan dosing with daily TNX-103 (oral) doses in Phase 3 clinical study.
Concerning imatinib, the decision to prioritize the Phase 3 testing of levosimendan places the start of a Phase 3 imatinib trial likely outside the 2023 timeframe, pending fundraising to support that trial and other strategic considerations.
Price Action: TENX shares are down 2.73% at $0.3735 on the last check Wednesday.

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