Indifference to Pain, Congenital, Autosomal Recessive

Relief Therapeutics Announces Positive 12-Month Stability Data for Inhaled and Intravenous Preparations of RLF-100 ® (Aviptadil Acetate) Relief to revised provisional patent application for RLF-100 ® based on the new stability results GENEVA, SWITZERLAND / ACCESSWIRE / April 17, 2023 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief Therapeutics, or Relief), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced positive 12-month stability data for the liquid and lyophilized preparations of RLF-100 ® , intended for intravenous (IV) and inhaled administration. RLF-100 ® is the company's proprietary, investigational formulation of aviptadil acetate. The data from the stability study showed that both inhaled and IV RLF-100 ® demonstrated high purity levels at 12 months at all temperatures tested, including refrigerated and room temperature environments. The results are consistent with prior data observed at three- and six-month intervals. The stability testing study will continue to determine the maximum shelf life of RLF-100 ® . Based on the latest results, Relief Therapeutics intends to amend its previously filed provisional patent application for RLF-100 ® with the new findings. If granted, this patent could provide exclusivity for RLF-100 ® at least until 2042, without considering Hatch-Waxman extensions or other patent term adjustments. The Hatch-Waxman Act permits a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. "The testing conducted to date has consistently shown that our novel, optimized composition of aviptadil acetate provides better stability results in both the liquid and lyophilized preparations. RLF-100 ® was shown to be shelf stable and active after one year at temperatures suitable for shipping and long-term storage. This is an important milestone toward commercialization to ensure that RLF-100 ® is safe and effective, no matter where in the world it is supplied." said Jack Weinstein, chief executive officer at Relief Therapeutics. "We believe this new, stable formulation has significant clinical and commercial value and our goal is to establish RLF-100 ® as the standard of care for the prevention and treatment of respiratory failure and its complications in both the acute and chronic applications." Stability testing of pharmaceutical products is mandatory for regulatory approvals. If a product fails to meet the standards prescribed by regulatory authorities, the product will not be granted approval for commercialization. Planning, execution and completion of studies in given timelines plays a major role in securing approval and ensuring a product reaches patients who need it. RLF-100 ® is under development for the potential treatment of acute and chronic lung diseases, including pulmonary sarcoidosis, infectious acute respiratory distress syndrome (ARDS), checkpoint inhibitor-induced pneumonitis (CIP) and chronic berylliosis. The U.S. Food and Drug Administration (FDA) granted RLF-100 ® Orphan Drug designation (ODD) to inhaled RLF-100 ® for the potential treatment of pulmonary sarcoidosis in August 2021. About Drug Stability Requirements The purpose of long-term and accelerated stability testing is to determine how long a drug product will maintain the properties and characteristics, such as purity, efficacy and structure, it possessed at the time of manufacture as well as the quality of a drug product over time while under the influence of environmental conditions such as temperature, humidity and light. Under long-term and accelerated stability storage conditions, the drug is evaluated by high performance liquid chromatography (HPLC) to separate, identify and quantify each chemical component to a very high degree of resolution to assess if any changes occur in the chemical composition. Stability studies are conducted during all phases of drug development to satisfy the regulatory requirements for clinical trials. Data from these studies is then used to establish recommended storage conditions, retest intervals and shelf life. Demonstrating long-term stability of a drug to be used in human clinical testing is essential to prove the potency and efficacy of the drug is not affected during prolonged shelf life. Long-term stability is completed over three years, with reporting at 0, 3, 6, 9, 12, 18, 24 and 36 months. Accelerated stability is completed over six months, with reporting at 0, 3 and 6 months. [1] , [2] About RLF-100 ® (aviptadil acetate) Aviptadil acetate is a synthetic form of vasoactive intestinal peptide (VIP) comprising 28 amino acids, which was first discovered in 1970. Although initially identified in the intestinal tract, human VIP is now known to be produced throughout the body and primarily concentrated in the lungs. VIP has shown a multimodal mechanism of action: decrease of inflammatory cytokines release leading to prevention of cytokine storm syndrome and viral replication, immunomodulating effect, vasodilating and bronchodilating effects and prevention of surfactant depletion. Seventy percent of VIP in the body is bound to a less common type of cell in the lung, the alveolar epithelial type II (AT2) cell, which is critical to the absorption of oxygen into the body. Aviptadil acetate has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, idiopathic pulmonary fibrosis, asthma, pulmonary arterial hypertension and sepsis-induced acute respiratory distress syndrome. For example, a combination of aviptadil with phentolamine is approved for the treatment of erectile dysfunction by intra-cavernous injections in countries outside the U.S. In early 2022, an unrelated pharmaceutical company in India received emergency use approval for its own formulation of aviptadil for the treatment of COVID-19 from the Drugs Controller General of India. While their approval does not affect the application for approval of our formulation in other countries, it substantiates our original hypothesis that RLF-100 is a potentially viable treatment for COVID-19-related ARDS. About Relief Therapeutics Relief Therapeutics is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with select specialty and rare diseases and disorders. Relief Therapeutics' portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic™ and TEHCLO™ drug delivery platform technologies and a highly targeted clinical development pipeline consisting of risk-mitigated assets to address rare metabolic disorders, rare skin diseases and rare respiratory diseases. In addition, Relief Therapeutics is commercializing several legacy products via licensing and distribution partners. Our mission to provide therapeutic relief to those suffering from rare diseases and disorders is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief Therapeutics' headquarters are in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Rome. Relief Therapeutics is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, please visit our website at or follow Relief Therapeutics on LinkedIn and Twitter . FOR MEDIA/INVESTOR INQUIRIES CONTACT: RELIEF THERAPEUTICS Holding SA Catherine Day Vice President, IR & Communications contact@relieftherapeutics.com LifeSci Advisors Irina Koffler +1-917-734-7387 ikoffler@lifesciadvisors.com DISCLAIMER This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors, which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief Therapeutics' filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief Therapeutics. Copies of Relief Therapeutics' filings with the SEC are available on the SEC EDGAR database at Relief Therapeutics does not undertake any obligation to update the information contained herein, which speaks only as of this date. REFERENCES [1] International Council for Harmonisation (ICH). Technical Requirements for Pharmaceuticals for Human Use. Quality Guidelines: Q1A - Q1F Stability. Available at: . Accessed on April 14, 2023. [2] U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). May 2021. Guidance For Industry: Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC). Available at: . Accessed on April 14, 2023. SOURCE: Relief Therapeutics Holdings AG View source version on accesswire.com:

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 additional patent protection. "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." 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 be produced throughout the body and to be primarily concentrated in the lungs where it has shown a multimodal mechanism of action: specifically, a decrease of inflammatory cytokines release leading to prevention of cytokine storm syndrome and viral replication, an immunomodulating effect, vasodilating and broncho-dilating effects, and prevention of surfactant depletion. Seventy percent of VIP in the body is bound to a less common type of cell in the lung, the alveolar type 2 cell, which is critical to 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 sepsis-induced acute respiratory distress syndrome. A combination of aviptadil with phentolamine is approved for the treatment of erectile dysfunction by intra-cavernous injections in countries outside the U.S. RLF-100® is under development for certain acute and chronic lung diseases, including pulmonary sarcoidosis, for which it was granted an Orphan Drug Designation ("ODD") by the FDA. RLF-100® is also being explored for treatment of checkpoint inhibitor-induced pneumonitis ("CIP"), an indication in which Relief's wholly-owned subsidiary, AdVita LifeScience GmbH, received Swiss method-of-use patent protection related to the inhaled formulation of RLF-100® into at least 2039. RLF-100® will also be evaluated in treating non-COVID-19-related ARDS 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 treatments approved and which is characterized by severe inflammation of the lungs, coughing and increasing breathlessness (dyspnea). 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 has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). Relief also continues to study aviptadil for several possible lung related conditions. Finally, Relief's 2021 acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs. RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit . Follow Relief on LinkedIn. CONTACT: RELIEF THERAPEUTICS Holding SA Jack Weinstein Chief Financial Officer and Treasurer contact@relieftherapeutics.com FOR MEDIA/INVESTOR INQUIRIES: Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning 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 U.S., the U.K., or the E.U. for any disease, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX and with the U.S. Securities and Exchange Commission, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be 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. SOURCE: Relief Therapeutics Holdings AG View source version on accesswire.com:

LOS ANGELES, Nov. 18, 2014 /PRNewswire/ -- Sanguine Biosciences a biotechnology company focusing on technology development, patient engagement and study recruitment will use its proprietary mobile application and direct-to-patient platform, called Sangre, to help Pfizer Inc. find and recruit people diagnosed with Congenital Insensitivity to Pain (CIP) and their family members to participate in voluntary research, which will be used to help potentially identify DNA mutations and hopefully aid in informing the development of potential therapies for chronic pain. CIP, also known as congenital analgesia, is a rare condition characterized by a person's inability to feel physical pain. There are an estimated 40 diagnosed cases of CIP worldwide but there may also be many more undiagnosed cases. Through Sanguine's mobile application, medical technicians are empowered to more quickly and easily collect medical data directly from individuals at any location, rather than only being able to do so in a physician's office or hospital. Sanguine's application makes it possible for qualified participants in over 25 metro areas around the country to schedule an appointment with a local phlebotomist and make a blood donation to Pfizer's study.  "What is exciting about this is the shared vision of patients and researchers working together for a common goal," says Brian Neman, CEO of Sanguine. "It's using our technology and non-profit network combined with Pfizer's interest in creating innovative new therapies that may be exceptionally powerful here, especially for such a rare condition like CIP." "By comparing the DNA sequence of individuals with CIP with that of their unaffected family members, we hope to be able to possibly identify DNA mutations that are attributable to CIP," said Ruth McKernan, Head of Neusentis, Pfizer's research unit for pain and sensory disorders. "Our aim is to use this information to aid in potentially identifying new drug targets and developing potential therapies for chronic pain." Sanguine currently works with the top 20 pharmaceutical companies in the world to help fulfill their biospecimen collection needs. About Sanguine Sanguine is a technology company providing services to the personalized medicine and biomedical research market by efficiently collecting and providing biological specimens and data to companies and institutions developing new therapeutic solutions. The company has developed a mobile application that enables medical technicians to locally collect blood samples and medical data directly from individuals interested in advancing the understanding and treatment of disease in the comfort of individuals' homes, as opposed to within the physician's office or hospital, an inefficient process that is currently delaying pharmaceutical research projects. Contact: Tyler Dornenburg Marketing Manager 310.912.9960 TDornenburg@SanguineBio.com Logo - SOURCE Sanguine Help employers find you! Check out all the jobs and post your resume.