This new formulation may have important clinical uses for a variety of rare lung diseases
GENEVA, SWITZERLAND / ACCESS CABLE / August 3, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (“Relief“), a biopharmaceutical company seeking to provide serious disease therapeutic benefit to patients with high unmet need, today announced promising three-month stability data on a new formulation of RLF-100® (aviptadil). Based on the results so far, Relief is evaluating the opportunity to apply for additional patent protection.
“Aviptadil, when dissolved in saline, is known to have uncertain stability properties, creating significant challenges for pharmaceutical supply and use. The development of this new RLF-100® formulation therefore has significant clinical and commercial value. In particular, the new formulation of Relief appears to be shelf-stable at temperatures suitable for shipping and long-term storage,” said Raghuram (Ram) Selvaraju, Ph.D., chairman of Relief’s board of directors. “This new and stable formulation potentially allows RLF-100® to be delivered via multiple routes of administration for the treatment of multiple lung disease indications, including pulmonary sarcoidosis, acute respiratory distress syndrome (ARDS), berylliosis and lung-induced pneumonitis. by checkpoint inhibitors (CIPs), 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, after which patients will have the option to participate. in the extension phase. A pre-IND meeting with the US 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 result, the trial is expected to start during 2023.”
ABOUT 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. Although initially identified in the intestinal tract, human VIP is known to it is produced throughout the body and concentrated mainly in the lungs where it has shown a multimodal mechanism of action: specifically, a decrease in the release of inflammatory cytokines leading to the prevention of cytokine storm syndrome and viral replication, an immunomodulatory effect, vasodilator and bronchodilator effects, and prevention of surfactant depletion. Seventy percent of the VIP in the body is bound to a less common cell type in the lung, the type 2 alveolar cell, which is critical for the transmission of oxygen to the body.
RLF-100 has a 20-year history of safe human use in multiple human trials for sarcoidosis, idiopathic pulmonary fibrosis, asthma, pulmonary arterial hypertension, and sepsis-induced acute respiratory distress syndrome. A combination of aviptadil and phentolamine is approved for the treatment of erectile dysfunction by intracavernous injection in countries outside the US.
RLF-100® is in development for certain acute and chronic lung diseases, including pulmonary sarcoidosis, for which it has been granted an orphan drug designation (“ODD”) by the FDA. RLF-100® is also being explored for the treatment of checkpoint inhibitor-induced pneumonitis (“CIP”), an indication in which Relief’s wholly owned subsidiary, AdVita LifeScience GmbH, received Swiss patent protection from method of use related to the inhaled formulation. of RLF-100® in at least 2039. RLF-100® will also be evaluated in the treatment of ARDS unrelated to COVID-19 with a particular focus on infectious ARDS. There are also plans to conduct European proof-of-concept clinical development of RLF-100® in the treatment of chronic berylliosis, an orphan lung disease for which there are no approved treatments and which is characterized by severe inflammation of the lungs. , cough and increased dyspnea (dyspnea).
ABOUT RELIEF
Relief focuses primarily on molecule-based clinical-stage programs with a history of clinical testing and use in human patients or a strong scientific rationale. Relief has a collaboration and licensing agreement with Acer Therapeutics for the development and worldwide commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including UCDs and syrup urine disease. maple (MSUD). Relief also continues to study aviptadil for various potential lung-related conditions. Finally, Relief’s 2021 acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought Relief a diverse portfolio of commercialized and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and is listed in the US on OTCQB under the symbols RLFTF and RLFTY. For more information visit www.relieftherapeutics.com. Follow the relief on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
jack weinstein
Financial Director and Treasurer
[email protected]
FOR MEDIA/INVESTOR INQUIRIES:
Rx communications group
miguel miller
+1-917-633-6086
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Disclaimer: This communication expressly or implicitly contains certain forward-looking statements about RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the US press releases and filings with SIX and with the US Securities and Exchange Commission. , which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA provides this communication as of this date and does not undertake to update any of the forward-looking statements contained in this document as a result of new information, future events or otherwise.
FONT: Relief Therapeutics Holdings AG
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https://www.accesswire.com/710682/Relief-Therapeutics-Announces-Promising-Initial-Stability-Data-on-a-New-Formulation-of-RLF-100R-Aviptadil