PORTFOLIO AND PIPELINE
Relief's portfolio consists of a balanced mix of marketed, revenue-generating products and globally patented drug delivery platform technologies. The Company's pipeline spans three core therapeutic areas: rare dermatologic disorders, rare metabolic disorders, and rare respiratory diseases. In addition, the Company is commercializing several legacy products via licensing and distribution partners.
RARE DERMATOLOGIC DISORDERS
RLF-TD011
RLF-TD011 was developed using the TEHCLOTM proprietary technology and is a highly pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), with pH between 2.5 - 3.0 and high reduction- oxidation potential (ORP 1.000 - 1.200 mV). It is a sprayable solution enabling targeted application while avoiding skin contact and cross-contamination.
RLF-TD011 is being studied for the treatment of epidermolysis bullosa (EB), a group of rare, genetic skin disorders which cause the skin to blister and tear from minimal contact or friction. EB affects approximately 500'000 individuals worldwide.
The Company developed RLF-TD011 as a differentiated acid oxidizing solution of hypochlorous acid that combines strong antimicrobial action with anti-inflammatory properties, thereby allowing for infection control, reduction of wound colonization and improved wound healing. The Company believes RLF-TD011, if approved, may be a fast, easy to use, and effective treatment for EB wound care management. Importantly, RLF-TD011 could also enhance the efficacy and usability of newly developed EB treatments given its unique properties.
This drug candidate was granted Orphan Drug Designation (ODD) by the FDA for the treatment of EB. The ODD qualifies the sponsor of the treatment for certain development incentives, including seven-year marketing exclusivity after FDA marketing approval is received.
The results of a proof-of-concept, investigator-initiated study evaluating RLF-TD011 as a treatment for EB are expected in mid- to late-2024.
RARE METABOLIC DISORDERS
PKU GOLIKE®
PKU GOLIKE is being commercialized for the dietary management of phenylketonuria (PKU), a rare inherited disorder affecting approximately 350'000 patients in the world's key markets. Patients with PKU require supplementation of amino acids formulated as foods for special medical purposes (FSMP) to prevent protein deficiency. Currently available FSMPs may lead to poor or suboptimal clinical outcomes and compliance because they are rapidly absorbed and are characterized by an unpleasant odor and aftertaste.
PKU GOLIKE, engineered with the patent protected, proprietary drug delivery technology named “Physiomimic,” is the first prolonged-release amino acid mix product that (i) mimics the absorption profile of dietary proteins while (ii) offering effective taste and odor masking. With these characteristics, PKU GOLIKE is a uniquely differentiated product, offering improved metabolic management and the opportunity for better compliance for PKU patients of all age groups.
PKU GOLIKE is currently available in the U.S. and several European countries.
TYR GOLIKE® and HCU GOLIKE®
TYR GOLIKE AND HCU GOLIKE are developed with the Company's Physiomimic Technology™ drug delivery platform for the dietary management of tyrosinemia (TYR) and homocystinuria (HCU).
TYR and HCU require lifelong diets with significant compliance challenges, often due to the poor palatability of AAs and the suboptimal nutritional value from the fast absorption of standard products. Given the limited range of products available for these rarer diseases, GOLIKE can offer substantial benefits to patients. Relief anticipates the development and regulatory completion of GOLIKE for the dietary management of TYR in 2025 and of HCU in 2026.
RLF-OD032
RLF-OD032 is a novel liquid formulation of a Sapropterin dihydrochloride product in oral suspension intended for the treatment of PKU. If approved, RLF-OD032 would be the first and only liquid formulation of a Sapropterin dihydrochloride product and is expected to improve patients' acceptance and compliance by reducing the amount of drug product that must be consumed compared to other generic versions of Sapropterin dihydrochloride.
The Company is preparing the initiation of a Pilot PK Trial in mid-2024 and expects to file a 505(b)(2) NDA with the FDA upon completion of a Pivotal PK Trial.
OLPRUVA®
OLPRUVA is a novel formulation of sodium phenylbutyrate powder approved in the U.S. for the treatment of certain urea cycle disorders (UCDs). OLPRUVA microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach to avoid a bitter taste while still allowing for rapid systemic absorption.
Relief in-licensed the rights for OLPRUVA in Europe and funded part of the development of OLPRUVA in the U.S. by Acer Therapeutics, Inc. (Acer). OLPRUVA is currently marketed in the U.S. by Acer (Acer), a wholly owned subsidiary of Zevra Therapeutics, Inc. (NASDAQ: ZVRA). Relief is entitled to receive a 10% continuing royalty on the net sales of OLPRUVA in the U.S. up to a cumulative amount of USD 45 million.
RARE PULMONARY DISEASES
RLF-100®
RLF-100® (aviptadil) is a synthetic form of vasoactive intestinal peptide (VIP) consisting of 28 amino acids, which was first discovered in 1970.
Relief developed a proprietary and patent-protected stable aviptadil formulations intended for intravenous (IV) and inhaled administration as standard of care for the prevention and treatment of respiratory failure and its complications in both the acute intensive care and chronic ambulatory settings. The Company sees opportunity to develop RLF-100 in acute respiratory distress syndromes (ARDSs) and for certain chronic lung diseases (CLDs), including sarcoidosis, berylliosis and checkpoint inhibitor-induced pneumonitis (CIP).
LEGACY PRODUCTS
The Company's legacy products are revenue-generating, approved products marketed in several countries including the U.S. and Europe, originally developed and patented by Relief and subsequently licensed to third parties. They primarily include:
SETOFILM/ONDISSOLVE, the first prescription-only, orodispersable film medicine (ondansetron) approved in Europe and Canada.
CAMBIA, an off-patent, potent non-steroidal anti-inflammatory drug (diclofenac potassium) widely used for treating inflammatory conditions and pain management.
VOLTADOL, a topical patch delivering diclofenac sodium for the local treatment of painful, acute conditions such as muscle and joint strains.
Additional information on the Company's products, development programs, and targeted indications is available in the portfolio and pipeline section of Relief's Annual Report 2023.