Presented at the 13th edition of the ICIEM (International Congress of Inborn Errors of Metabolism) in Rio de Janeiro, the results of the pre-clinical kinetic study indicate that APR’s Physiomimic™ Technology is able to modify the release of clinically relevant amino acids (AAs) by prolonging their absorption profiles when compared to the same mix of AAs without the application of the technology. APR’s product, a Phenylalanine (PHE)-free AA mix, is intended to be used for the management of patients with phenylketonuria (PKU).
The study suggests that APR’s innovative formulation has the potential to allow a more efficient disposition and utilization of the absorbed AAs that, in addition to contributing to maintain PHE levels within the recommended ranges, may result in re-balanced AA distribution as well as less prominent fluctuations of PHE levels over time.
APR’s Physiomimic™ Technology aims at meaningfully fulfilling significant unmet needs of PKU patients, caregivers and HCP.
As shown by the results of a global market research project commissioned by APR to IDR Medical, a leading international healthcare market research organization, dietary compliance is still a key issue in PKU management.
Physicians and dieticians’ concerns mainly focus on securing and supporting patient adherence to the prescribed dietary regimen, while most of the patients and HCPs reported that palatability (taste and odor) of AA formulations still represents a significant obstacle to obtain better and long-term patient compliance to the dietary treatment.
APR’s Physiomimic™ Technology has the ability of remarkably masking the AA taste and odor, with potential positive consequences on aftertaste making this product a palatable option.
“The development plan to characterize our innovative product for PKU is robust, – adds Giorgio Reiner, APR’s Corporate Director R&D – “with the next major step being a clinical kinetic study in human volunteers as a proof of concept of the prolonged release of amino acids and their consequent physiological absorption. Other pre-clinical studies as well as clinical evidences will reinforce the scientific profile of our proprietary technology and product to help us continue this journey.”