Clinical Trials

* On May 10, 2016, AM-Pharma announced that the company has published data from its Phase I trial of recAP, for the potential treatment of acute kidney injury (AKI), in the journal of Clinical Pharmacokinetics. The lead study author is Peter Pickkers (Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands). Using data from this Phase I trial and pharmacokinetic modelling, the optimal dosing regimen for the ongoing STOP-AKI, adaptive Phase II study was predicted to consist of 1 hour infusions of 250, 500 and 1,000 U/kg recAP, once daily, for three consecutive days. The STOP-AKI trial recently reported that it had completed its first stage, and an independent data monitoring committee had selected a single optimal dose for stage 2 of the trial, in a further 170 patients.

The range of regimens was established in a randomized, double-blind, placebo-controlled Phase I trial, where healthy volunteers received either a single dose of recAP (200, 500, 1,000 or 2,000 U/kg; n=33), or multiple doses of recAP (500 or 1,000 U/kg; n=18) comprised of single doses on three consecutive days all administered as a 1 hour intravenous infusion. Serum recAP concentrations, alkaline phosphatase (AP) activity levels, anti-drug antibodies, and other safety and PK parameters were measured in the trial.

In the single dose group, peak blood concentrations of recAP and AP activity levels were reached at the end of the 1 hour infusion. AP activity levels increased 35-200 fold over baseline endogenous AP activity, and remained 2.5 to 20 times higher after 24 hours. Sustained increases in blood AP activity were evident in the multiple dose groups, with AP levels in the highest dose group returning to baseline levels 10 days post final infusion. No serious adverse events were reported in any dose group.

* On March 26, 2014, AM-Pharma has announced the results of its Phase I trial with both single and multiple ascending doses, which demonstrate that recAP is safe and well tolerated at all doses. 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 II clinical trial results with bovine Alkaline Phosphatase (bovine AP), in the treatment of patients with Acute Kidney Injury (AKI).

AM-Pharma is currently finalising the Phase II 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.

* On September 23, 2013, AM-Pharma B.V., a biopharmaceutical company focused on the development of recombinant human alkaline phosphatase for inflammatory indications has announced that the first subjects have entered a Phase I trial of its recombinant AP (recAP) to treat Acute Kidney Injury (AKI). The company said that this is a significant milestone in its progress, as it re-enters the clinic with its new recombinant AP product. The Company previously presented strong, positive, Phase II data on an enzymatically comparable bovine extracted AP, which showed that AKI patients on alkaline phosphatasehad improved renal function, reduced length of stay in intensive care, and that alkaline phosphatase  was safe and well tolerated.

The Phase I study of recAP consists of 50 healthy volunteers, aims to confirm safety and tolerability, and investigate the pharmacology including enzyme activity in serum – a key indicator of the drug’s therapeutic potential. Recruitment to the trial will close in December 2013, with the results reporting in early 2014. Confirmation of the results seen in the previous bovine AP trials will enable the Company to seek approval for Phase II development in Q2 2014.