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 therapeutic benefit to patients with serious diseases with high unmet need, today announced promising three-month stability data on a new formulation of RLF-100® (aviptadil). Based on the results obtained so far, Relief is evaluating the possibility of filing for additional patent protection.
“Aviptadil, when dissolved in saline solution, is known to have uncertain stability properties, which leads to significant challenges for pharmaceutical supply and use. The development of this novel RLF-100® The formulation therefore has significant clinical and commercial value. In particular, the new Relief formulation appears to be shelf-stable at temperatures suitable for shipping and long-term storage,” said Raghuram (Ram) Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “This new stable formulation potentially enables RLF-100® be delivered by multiple routes of administration for the treatment of multiple lung disease indications, including pulmonary sarcoidosis, acute respiratory distress syndrome (ARDS), berylliosis, and checkpoint inhibitor (CIP)-induced pneumonia, that Relief seeks to pursue. As previously reported, we intend to initiate a phase 2b dose study in 72 patients with pulmonary sarcoidosis using inhaled RLF-100® administered over a period of 12 weeks, after which patients will have the option of participating in the extension phase. A pre-IND meeting with the US Food and Drug Administration (FDA) is scheduled to confirm efficacy and safety parameters along with the proposed dosing regimen and, based on a positive result, the trial expected to start in 2023.”
ABOUT THE 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 be produced throughout the body and be concentrated mainly in the lungs where it has shown a multimodal mechanism of action: in particular, 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 linked to a less common type of lung cell, the type 2 alveolar cell, which is essential for the transmission of oxygen to the body.
RLF-100 has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, idiopathic pulmonary fibrosis, asthma, pulmonary arterial hypertension, and acute respiratory distress syndrome induced sepsis. A combination of aviptadil and phentolamine is approved for the treatment of erectile dysfunction by intracavernous injections in countries other than the United States
RLF-100® is being developed for certain acute and chronic lung diseases, including pulmonary sarcoidosis, for which it has received orphan drug designation (“ODD”) from the FDA. RLF-100® is also being investigated for the treatment of checkpoint inhibitor (“CIP”)-induced pneumonia, an indication in which Relief’s wholly-owned subsidiary, AdVita LifeScience GmbH, has received method patent protection of Swiss use related to the inhaled formulation of RLF-100® until at least 2039. RLF-100® will also be evaluated in the treatment of ARDS unrelated to COVID-19 with particular emphasis on infectious ARDS. There are also plans to conduct a European proof-of-concept clinical development of RLF-100.® in the treatment of chronic berylliosis, an orphan lung disease for which there is no approved treatment and which is characterized by severe inflammation of the lungs, cough and increasing shortness of breath (dyspnoea).
Relief primarily focuses on clinical-stage programs based on molecules with a history of clinical trials and use in human patients or strong scientific rationale. Relief has entered into a collaboration and license 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 UCD and maple syrup urinary disease (MSUD). Relief is also continuing to study aviptadil for several possible lung conditions. Finally, Relief’s 2021 acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH have provided Relief with a diverse pipeline of commercialized and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and listed in the United States on the OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.
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Disclaimer: This communication expressly or implicitly contains certain forward-looking statements regarding 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, UK or EU for any disease, and (ii) risks discussed in RELIEF THERAPEUTICS Holding SA press releases and filings with SIX and the United States Securities and Exchange Commission, which could cause results, financial condition, performance or RELIEF THERAPEUTICS Holding SA’s actual achievements are materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
THE SOURCE: Relief Therapeutics Holdings SA
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