AM-Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory indications, announced the results of its Phase 1 trial with both single and multiple ascending doses, which demonstrate that recAP is safe and well-tolerated at all doses.
In total 50 healthy male and female volunteers were included in the randomized, double-blind, placebo-controlled, first-in-human, single and multiple dose escalation study, to investigate safety, tolerability, and pharmacokinetics of recAP administered intravenously. Volunteers in the single dose groups were administered one of four single doses, and those in the multiple dose groups were administered one of two multiple doses on three consecutive days. No safety issues were observed in any of the dose groups.
The trial also established recAP’s pharmacokinetic properties. These include dose exposures up to and above the target therapeutic range as determined in AM-Pharma’s earlier positive Phase 2 clinical trial results with bovine Alkaline Phosphatase (bovine AP), in the treatment of patients with Acute Kidney Injury (AKI).
“Our wealth of knowledge around Alkaline Phosphatase, gained from our earlier Phase 2 programs with bovine AP, meant that at the start of this clinical trial we expected that recAP would be safe and well tolerated,” said Erik van den Berg, CEO of AM-Pharma. “It is nevertheless very encouraging to see that recAP is showing favorable pharmacokinetics, and should therefore provide superior tissue distribution and extended half-life beyond that seen with bovine AP. With this confirmation, alongside the safety profile, we are confident that recAP is a promising candidate to show therapeutic efficacy in its Phase 2 development.”
AM-Pharma is currently finalizing the Phase 2 trial protocol, for recAP to treat AKI, which will take advantage of “Adaptive Trial Design”– an increasingly adopted, and regulatory-endorsed, methodology that allows predefined modifications and expansion of a trial based on initial study results. Adaptive Trial Design increases the chances to obtain statistically relevant data to validate clinical products, and thus shorten product development times.
Date: March 26, 2014
Source: AM-Pharma
