Speedel says Novartis releases positive phase 3 results for SPP100 in hypertension

By E. Janene Geiss

Philadelphia, Jan. 19 - Speedel Holding Ltd. announced phase 3 clinical results for SPP100 in hypertension that demonstrated increased blood pressure control and a decrease of edema.

The results were released Thursday by Novartis, which also confirmed that SPP100 is on track for its first regulatory submission of SPP100 in the United States in early 2006 and in the European Union in the fourth quarter of 2006, according to a company news release.

These submissions will be for SPP100 as a monotherapy treatment and as co-administration with other anti-hypertensive therapies based on trials from more than 8,000 patients.

SPP100 is the first-in-class once daily oral renin inhibitor being developed for the treatment of hypertension.

Speedel in-licensed the compound from Novartis and successfully developed SPP100 through phases 1 and 2 before Novartis exercised a license-back option in 2002, officials said.

"We are delighted with the latest data from Novartis reconfirming SPP100 as a potential gold standard, first-in-class therapy for treating hypertension. The clinical data generated so far by both Novartis and Speedel shows the potential benefits of co-administration of SPP100 with the four most common classes of blood pressure modulators," Alice Huxley, chief executive officer of Speedel, said in the release.

"Hypertension is one of the largest and growing unmet medical needs across the world. SPP100 potentially offers benefits over current therapies, particularly for improved protection of end-organs such as the heart and kidneys, officials said. The success of SPP100 clearly demonstrates the viability of Speedel's business model and our research and development capabilities," Huxley added.

At its financial results conference in Basel, Switzerland, Novartis disclosed the results from three phase 3 clinical trials of SPP100 in co-administration with amlodipine (calcium channel blocker), with ramipril (ACE -I) and as long-term monotherapy.

Last year Novartis released data on SPP100 in co-administration with an ARB (angiotensin II receptor antagonist) and a diuretic.

Speedel said that this new co-administration data builds on Speedel's clinical findings about the benefits of co-administration therapy shown in 2001 and 2002 in pilot clinical studies with SPP100 in co-administration with an ARB, as well as with an ACE-I (angiotensin converting enzyme inhibitor) or a diuretic.

The phase 3 trial in which SPP100 was co-administered with amlodipine (calcium channel blocker), showed results including excellent tolerability and safety, increased benefit on blood pressure control at a dose of 150 mg with 5 mg of amlodipine and a decrease in edema, a common side-effect of calcium channel blockers.

The phase 3 trial in which SPP100 was used as monotherapy and was co-administered with ramipril (ACE-I) showed results including double-digit decreases in systolic and diastolic blood pressure as a monotherapy, statistically and clinically significant additional decreases in systolic and diastolic blood pressure in co-administration with ramipril, decrease in dry cough, a common side effect of ACE inhibitors, excellent responder rates as monotherapy and in co-administration with ramipril and confirmation of efficacy and tolerability shown in an earlier phase 2 pilot trial performed by Speedel.

The phase 3 trial in which SPP100 was given as monotherapy demonstrated excellent safety and placebo-like tolerability in hypertensive patients treated longer than one year, officials said.

This new data together with previous data released by Novartis and Speedel confirms the attractive profile of SPP100 as a first-in-class therapy for treating hypertension, officials said.

Novartis also said Thursday that extensive data for SPP100 will be presented at the American Society of Hypertension meeting in New York in May. Further data also will be presented this year from phase 3 clinical trials, officials said.

Speedel is a Bridgewater, N.J., biopharmaceutical company that develops innovative therapies for cardiovascular and metabolic diseases.

Novartis is a Basel, Switzerland, pharmaceutical and health care products company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.