Date: 2011-05-23
Type of information: Results
phase: 2
Announcement: results
Company: Actelion (Switzerland)
Product: CRTH2 antagonist
Action
mechanism: Actelion's CRTH2 antagonist blocks some of the effects of prostaglandin D2 (PGD2) on inflammation and, as a consequence, the amplification and maintenance of allergic reactions. It targets allergic inflammation, with the potential of being used as therapy in both asthma and/or allergic rhinitis as well as in many other potential indications that are based on allergic inflammation.
Disease: seasonal allergic rhinitis
Therapeutic area: Allergic diseases - Immune diseases
Country:
Trial
details: The study was a prospective, multi-center, double-blind, placebo-controlled, active-reference, multiple-dose levels, randomized, parallel-group Phase II study. The study enrolled 579 patients, who were treated for two weeks, with the primary outcome measure to demonstrate efficacy versus placebo being the mean change from baseline in Daytime Nasal Symptom Score over the entire treatment period.
Latest
news: Actelion Ltd has announced that a Phase II study with its novel orally-active CRTH2 antagonist in seasonal allergic rhinitis has met its primary endpoint with statistical significance (p<0.05). The study assessed the efficacy and tolerability of various doses of this novel CRTH2 antagonist in adult patients with seasonal allergic rhinitis ("hay fever") due to mountain cedar pollen. Treatment in this study was well tolerated across all treatment groups and no serious adverse events were reported. Following full analysis of the study, results will be made available through scientific publication.
A Phase II dose-finding study in asthma is currently enrolling and is expected to report results mid-2012.
* On April 2, 2012, Actelion has provided an update on its CRTH2 program. The company has announced that will re-direct its development efforts in the anti-inflammatory area, focusing on a potent follow-up CRTH2 antagonist currently in Phase I clinical development.
•Two recently concluded studies with the first orally-active CRTH2 antagonist, setipiprant, in asthma (Phase IIb) and seasonal allergic rhinitis (Phase III profiling) did not confirm efficacy findings made in earlier studies. Accordingly, clinical development with this well-tolerated agent in these indications is being discontinued.
Actelion's CRTH2 antagonist, setipiprant, blocks the effects of prostaglandin D2 (PGD2) role in inflammation and, in consequence, the amplification and maintenance of allergic reactions. It targets the allergic inflammation at the beginning of the cascade. Earlier, positive data was obtained in an allergen challenge proof-of-mechanism study in patients with mild to moderate allergic asthma. In the 18-patient 2-period crossover double-blind placebo-controlled study, the compound was well tolerated and demonstrated efficacy versus placebo on the primary endpoint (FEV1) during the late allergic reaction (3-10 hours) after a bronchial allergen challenge.
A Phase II study with setipiprant in seasonal allergic rhinitis (SAR) met its primary endpoint with statistical significance (p<0.05). The two week study assessed the efficacy and tolerability of various doses of setipiprant in 579 adult patients with SAR ("hay fever") due to mountain cedar pollen. Treatment in the study was well tolerated across all treatment groups and no serious adverse events were reported.
Now, by focusing on the more potent follow-up compound, Actelion expects to further develop the understanding of the CRTH2 mechanism as a potential anti-inflammatory mode of action in allergic indications.
