UTHR Presents Data from FREEDOM-M - Analyst Blog
June 07 2011 - 11:15AM
Zacks
United Therapeutics Corporation (UTHR) recently
presented much-awaited results from a phase III study (FREEDOM-M)
conducted with oral treprostinil in patients with pulmonary
arterial hypertension (PAH).
Preliminary data showed that oral treprostinil met its primary
endpoint of change in six-minute walk distance (6MWD) at 12 weeks.
Patients in the oral treprostinil arm improved their median 6MWD by
about 23 meters compared to patients on placebo. While the median
change from baseline in the oral treprostinil group was 25 meters,
the change was -5 meters for placebo at week 12. Despite the
statistically significant results, United Therapeutics shares were
down 5.9% as the improvement in 6MWD was below expectations.
A significant improvement was also observed in the combined 6MWD
and Borg Dyspnea Score rating (shortness of breath test).
However, United Therapeutics said that no significant difference
between oral treprostinil and placebo was observed in several
secondary efficacy measures like change in Borg Dyspnea Score
rating, trough walk at Week 11, change in Dyspnea Fatigue Index,
change in WHO functional class, time to clinical worsening and PAH
signs and symptoms.
The randomized, double-blind, placebo-controlled FREEDOM-M study
enrolled 349 patients who were not receiving any approved PAH
medication. The primary analysis was conducted on the 228 patients
who received the 0.25 mg tablet at randomization. Meanwhile, an
analysis of all the participants in the study showed that patients
in the oral treprostinil arm witnessed a 25.5 meter improvement in
their median 6MWD compared to patients in the placebo arm.
Treprostinil is already available in an injectable form under
the trade name Remodulin and an inhaled version under the trade
name Tyvaso. The successful development of oral treprostinil would
allow United Therapeutics to have a varied range of therapies in
the PAH market. Currently available therapies in the PAH market
include products like Gilead’s
(GILD) Letairis and Pfizer’s (PFE) Revatio among
others.
Neutral on United Therapeutics
We currently have a Neutral recommendation on United
Therapeutics. Now that results from FREEDOM-M are out, we expect
investor focus to shift to the FREEDOM-C2 study which will report
preliminary data in September 2011. The FREEDOM-C2 study is being
conducted with 313 patients who are receiving an endothelin
receptor antagonist and/or a PDE-5 inhibitor.
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