With Ph3 LEVEL Coming in 3Q26, Here's Why Now Is The Time to Own & PT Update

Research evidence excerpt

With Ph3 LEVEL Coming in 3Q26, Here's Why Now Is The Time to Own & PT Update

C O M PA N Y N O T E

J u n e 1 1 , 2 0 2 6

likely in this population, and really any stat sig separation would be enough to

support a win. As emphasized by our past KOL, the PH-HFpEF population represent

especially severe patients, such that it would be surprising to see any substantial 6MWD

placebo effect. The doc reminded us that placebo response is especially rare in PH trials

(despite recent PAH data), but nonetheless, PH-HFpEF altogether represents an older

and less healthy population. Thus, in absence of any heavy background treatment, it

would be very unlikely for PH-HFpEF patients to drive a placebo response (recognizing

the background therapy policies in Ph3 LEVEL required patients to enter on a stable

regimen and still meet all enrollment criteria to ensure that all participants still had

ample room for improvement). In fact, recall that in Ph2 HELP, the placebo group

actually resulted in a -12.7 m decrease to 6MWD at Week 6, further substantiating the

expectation for no/minimal placebo response in Ph3 LEVEL. Moreover, consider that

TENX implemented important recruitment criteria around 6MWD to further eliminate

potential for placebo response such that patients needed to have an entry 6MWD

between 100 m and 450 m, where the walk could only be limited as a result for dyspnea

due to PH-HFpEF. In other words, if the patient's walking distance was limited due to the

use of a mobility aid (such as a walker or cane), joint pain, RA flare, etc., they were not

eligible to participate. Putting this altogether, we also find it important to recognize that

any stat sig separation on 6MWD would constitute a win given nothing is approved for

this high unmet need patient population.