Relief Therapeutics Holding SA / Key word(s): Research Update
03-Aug-2022 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.
Relief Therapeutics Announces Promising Initial Stability Data on a New Formulation of RLF-100® (Aviptadil)
This new formulation may have important clinical uses for a variety of rare lung diseases
Geneva, Switzerland, August 3, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, 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.
“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.”
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).
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.
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|Company:||Relief Therapeutics Holding SA|
|Avenue de Secheron 15|
|Phone:||+41 22 545 11 16|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1411907|
|End of Announcement||EQS News Service|