Date: 2014-09-09
Type of information: Completion of the trial
phase: 2a
Announcement: completion of the trial
Company: Serodus (Norway)
Product: SER100
Action
mechanism: SER100 is an opioid-1 (ORL1, nociceptin receptor) partial agonist previously known as ZP120. SER100 was acquired from Zealand Pharma in 2010. The results from previous studies in chronic and acute heart failure indicate that SER100 has a potential to treat isolated systolic hypertension (ISH).
Disease: systolic hypertension
Therapeutic area: Cardiovascular diseases
Country: Finland, Hungary, Norway, UK
Trial
details: The SER100 Phase IIa was a multi-national study with participants from Finland, Hungary, United Kingdom and Norway. The study was managed by the CRO, Smerud Medical Research, Oslo, and partly financed by a grant from the Research Council of Norway.
Latest
news: * On September 9, 2014, Serodus announced the successful completion of a multi-centre Phase IIa clinical study for SER100, an opioid-1(ORL 1, nociceptin receptor) in patients with systolic hypertension. The primary objective of the study was to demonstrate if 10 mg SER100 given twice daily for two consecutive days by subcutaneous injections, was safe and well tolerated. No serious adverse events, no drop-outs and no difference in tolerability between placebo and SER100 were observed.
The secondary objective was to demonstrate if SER100 produced a reduction of systolic blood pressure compared to placebo. SER100 produced a statistical significant and clinically meaningful reduction of systolic blood pressure.
These results confirm the observations from previous clinical studies in healthy volunteers and patients with heart failure.
