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United Therapeutics Oral Treprostinil (UT-15C SR) - Likelihood of clinical trial
and commercial success
Description:
UT-15C SR might be United Therapeutics’ fourth treprostinil formulation to reach the market, but as an oral
agent it could be the most convenient of them all. However, UT-15C SR’s road to market has proven bumpier
than expected. The initial phase III combination trial, FREEDOM-C, missed the primary endpoint. Failure was
attributed to the aggressive dosing schedule which was hard to tolerate. The company developed lower
strength tablets and implemented a “start low and escalate slow” approach for the two ongoing phase III
trials – the monotherapy FREEDOM-M and the new combination FREEDOM-C2. The question is whether this
new gradual approach will enable patients to reach and sustain therapeutic blood levels of treprostinil and
whether the results will be strong enough to enable UT-15C SR to compete with oral PDE5 inhibitors and
ETRAs, the two drug classes that dominate the milder disease market. This report analyzes the likelihood
that UT-15C SR clinical trials will succeed, and their potential commercial and revenue implications for the
treprostinil franchise.
Contents:
INTRODUCTION
PULMONARY ARTERIAL HYPERTENSION
1. Prevalence
2. Prognosis
3. Current treatments
TREPROSTINIL
1. Subcutaneous treprostinil (Remodulin SC)
2. Intravenous treprostinil (Remodulin IV)
3. Inhaled treprostinil (Tyvaso)
ORAL TREPROSTINIL: UT-15C SR
1. Initial studies with the sustained release formulation
2. Drug interaction studies
3. Phase III program – the FREEDOM trials
- FREEDOM-C results
- A Revised FREEDOM-M is ongoing
- A new phase III combination trial is underway: FREEDOM-C2
OPINION
1. Prostacyclins have well established efficacy in PAH
2. Issues to consider regarding the oral sustained release formulation
3. What can we learn from parenteral treprostinil regarding optimal dose?
4. UT-15C SR doses of at least 3.5 mg may be required for therapeutic effect
5. Can patients titrate up to and tolerate 3.5 mg bid?
6. United Therapeutics has not disclosed a key piece of data
7. Does access to 0.25 mg enable titration to higher doses?
8. The dose titration schedule seems tight
9. The high Cmax poses a particular tolerability challenge for UT-15C SR
10. Timing of endpoint assessment may impact 6MW test results
11. Chance of success in phase III
MARKET CONSIDERATIONS
1. Can UT-15C SR expand use of prostacyclins among less severe patients?
2. Convenient for patients, much less so for doctors
3. The market opportunity in first, second and third line PAH therapy
4. Factors influencing commercial success
COMPETITION
1. Other prostacyclins in development
CONCLUSION
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