This new formulation may have important clinical uses for a variety of rare lung diseases
GENEVA, SWITZERLAND / ACCESSWIRE / August 3, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic benefit from serious diseases with high unmet need, announced today promising three-month stability data on a new formulation of RLF-100® (aviptadil). Based on the results thus far, Relief is evaluating the opportunity to file for additional patent protection.
Relief Therapeutics Holdings AG, Monday, July 18, 2022, Press release picture
Relief Therapeutics Holdings AG, Monday, July 18, 2022, Press release picture
"Aviptadil, when dissolved in saline, is known to have uncertain stability properties, resulting in significant challenges for pharmaceutical supply and use. The development of this novel RLF-100® formulation, therefore, has significant clinical and commercial value. In particular, Relief's new formulation appears to be shelf-stable at temperatures suitable for shipping and long-term storage" stated Raghuram (Ram) Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. "This new, stable formulation potentially allows RLF-100® to be delivered via multiple routes of administration for treatment of multiple lung disease indications including pulmonary sarcoidosis, acute respiratory distress syndrome (ARDS), berylliosis and checkpoint inhibitor-induced pneumonitis (CIP), all of which Relief seeks to pursue. As previously reported, we intend to initiate a phase 2b dose ranging study in 72 patients with pulmonary sarcoidosis using inhaled RLF-100® administered over a 12-week period, following which patients will have the option to participate in the extension phase. A pre-IND meeting with the U.S. Food and Drug Administration (FDA) is planned to confirm the efficacy and safety endpoints as well as the proposed dosing regimen and, based on a positive outcome, the trial is expected to begin during 2023.
