Relief Therapeutics Reports In Vivo Data Indicating Prolonged Release of Amino Acids Using its Physiomimic(TM) Technology May Have Benefits for the Treatment of PKU - Seite 2

"The paper's conclusions confirm the advantages of prolonged AA absorption using our patented Physiomimic^TM Technology, which has already been demonstrated in humans," stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. "The prolonged release of AAs made possible through our Physiomimic^TM Technology and used in the currently commercialized PKU GOLIKE(R) family of products in Europe, we believe, leads to absorption of AAs more closely resembling the natural protein in healthy humans, providing a distinct advantage for the treatment of patients with PKU. We are relentlessly working to bring PKU GOLIKE(R) as a treatment to PKU patients in the U.S. within 2022 while we are in the process of generating further clinical evidence that will support PKU GOLIKE as a prescription product."

About PKU GOLIKE(R)

The PKU GOLIKE(R) family of products are food for special medical purposes (FSMP) or medical formulas in the US consisting of a phenylalanine-free amino acid mix in granules. Engineered with the Company's patented Physiomimic^TM Technology platform, PKU GOLIKE(R) is the first prolonged-release amino acid product, characterized by a special coating that ensures a more physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

About Phenylketonuria or PKU

PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of phenylalanine free-amino acid-mix) to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's drug candidate, RLF-100^TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief's collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer's new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.