Relief Provides Corporate Update and Outlines Plans to Advance its Diversified Portfolio of Pipeline Candidates, Including RLF-100(TM) (Aviptadil)

GENEVA, SWITZERLAND / ACCESSWIRE /\November 11, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today provided a corporate update detailing, among other matters, its ongoing clinical development and regulatory activities, as well as its plans to accelerate the maturation of its pipeline.

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RLF-100(TM)

Relief remains committed to the development of RLF-100(TM) (aviptadil) for the treatment of respiratory complications of COVID-19 infection. A clinical program remains under way in Europe for inhalation-based administration, while the ACTIVE-3b/TESICO study sponsored by the U.S. National Institutes of Health ("NIH") assessing the intravenous formulation and the I-SPY trial sponsored by Quantum Leap testing the inhaled formulation also remain ongoing. Further, the parent company of Relief's U.S. collaboration partner has publicly reported that they are continuing to conduct an investigational study of inhaled aviptadil in the U.S. as well. In addition, Relief continues to pursue aviptadil for the treatment of pulmonary sarcoidosis, and authorization to commence a phase 2 randomized, double-blinded, placebo-controlled clinical trial in this indication was recently granted by the German medical regulatory authorities. In August 2021, Relief announced the receipt of U.S. Orphan Drug Designation for the use of aviptadil in treatment of sarcoidosis. Relief also intends to explore the clinical utility of aviptadil in acute respiratory distress syndrome ("ARDS") unrelated to COVID-19 infection, as well as in other pulmonary disorders, including chronic beryllium disease ("berylliosis") and checkpoint inhibitor-induced pneumonitis ("CIP"), in which AdVita has filed pending patent claims. Finally, Relief is also working to optimize the formulation of aviptadil.

As previously reported, in October 2021 Relief filed a lawsuit against NeuroRx, Inc. ("NeuroRx") and its Chief Executive Officer, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx relating to the development and commercialization of RLF-100(TM) (aviptadil). The complaint alleges, among other breaches of the Collaboration Agreement, that NeuroRx has failed to provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating IV RLF-100(TM) (aviptadil) for the treatment of acute respiratory failure due to COVID-19 (which data and information are required to be provided to Relief by NeuroRx under the Collaboration Agreement) and has failed to allow Relief to have input into NeuroRx's U.S. development program. Without doubt, Relief was disappointed that Emergency Use Authorization for aviptadil in the United States was denied. However, this decision by FDA does not affect Relief's commitment to the further development of this drug.