US-based The Medicines Company has initiated a Phase II trial of its investigational product ABP-700, which has been developed for the induction of general anesthesia and procedural sedation in patients.
The company has dosed the first patient as part of this trial, which follows completion of Phase I clinical pharmacology and dosing, as well as safety studies.
The company has named the Phase II-III development programme for the compound as ‘Verona’.
ABP-700, a new, positive allosteric modulator of the GABAA receptor, is not approved for commercial use in any market.
Within the first Phase II trial in the Verona programme, 75 patients who are undergoing elective colonoscopies at three sites in the Netherlands will be enrolled.
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The trial will evaluate three ABP-700 infusion regimens in order to enable successful procedure completion.
The Medicines Company surgery and peri-operative care senior vice-president and ABP-700 programme lead Jason Campagna said: "The five phase I studies we completed support our conclusions that ABP-700 has the potential of a unique profile, can be administered with routine pre-medications and co-medications, and is well tolerated in normal subjects.
"We are pleased with our progress to date, and look forward to sharing results from this first Phase II study in patients undergoing colonoscopy later this year."
Research revealed that ABP-700 produces dose-dependent levels of sedation ranging from light to moderate to deep, while its bolus and infusion doses could be given with pre-and co-medications such as opiates and benzodiazepines safely.
University Medical Centre Groningen department of anesthesiology professor Michel Struys said: "These three studies advance our understanding of the safety, pharmacology and tolerability of ABP-700 when given by bolus and infusion dose regimens, and when given in association with pre-medications and co-medications commonly used during procedural care and induction of anesthesia.
"Similar to our previously reported ANVN-01 study, these results show ABP-700 to be safe and generally well tolerated across a broad range of doses, dose regimens and alongside other medications used during procedural care of patients."
The company noted that ABP-700 is from a family of compounds invented by Dr Douglas Raines at the Massachusetts General Hospital.
