Tenax Therapeutics (NASDAQ:TENX) updated investors on its Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF (HELP) trial status last week in a January 13, 2020 release. Twenty-four patients have been randomized and an 86% initial response rate has been observed in screened patients. The average reduction in average pulmonary capillary wedge pressure (PCWP) was updated to 7.6 mmHg1. As a reminder, the statistically defined threshold for inclusion during the open label screen for participation in the randomization portion is 4.0 mmHg. On the safety side of the equation, no serious drug related adverse events have been reported.
The strong initial response to administration of Levosimendan is a positive and suggests strong statistical significance if it holds for the duration of the study. Management maintains its guidance that the trial will achieve full enrollment by the first quarter of 2020, followed by topline data a minimum of six weeks later. We anticipate accelerating enrollment as the sixteenth site has now been activated (up from 15 previously). While enrollment rate can vary, we note that compared to the last update on November 11th, there has been an increase from 17 enrollees to 24 enrollees, or seven added over a 63 day period.
Measurements from 22 enrolled patients demonstrated an improvement of pulmonary arterial pressure of PCWP of 7.6 mmHg, an average reduction in right atrial pressure of 5.2 mmHg and an average increase in cardiac output of 0.8 liters/minute. Each of the endpoints has achieved statistical significance.
Exhibit I – HELP Study Trial Design 2,3
We maintain our favorable view on Tenax given that there is no other approved treatment for PH-HFpEF. Furthermore, the Group II pulmonary hypertension population Tenax is targeting is much larger than the other groups, some of which have billion dollar plus treatments approved. The safety profile for Levosimendan is well understood and initial indications from the first administration of the drug are favorable. We also highlight the low valuation of the company compared to its potential. However, we note that the primary efficacy endpoints seek to demonstrate an improvement in the six minute walk test and improvement in quality of life among others and we will have to wait at a minimum until 1Q:20 for a topline readout. We will update our valuation following the announcement of topline data or other material event.
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1. The reading of 7.6 mmHg was taken during exercise following the initial Levosimendan infusion.
3. Following the initial administration of Levosimendan to determine whether or not the patient is a responder, responders are given five additional 24-hour infusions of Levosimendan over the subsequent five weeks.