The Food and Drug Administration (FDA) has granted Orphan Drug designation to aviptadil (RLF-100) for the treatment of sarcoidosis.

Sarcoidosis is a rare inflammatory disease characterized by the formation of granulomas in the body, most commonly in the lungs and lymph nodes. Aviptadil is an inhaled, synthetic formulation of vasoactive intestinal peptide (VIP). The investigational treatment has been shown to reduce inflammation in the lungs, preserve surfactant production, and protect alveolar type II cells from injury.

The designation is supported by an open-label, proof-of-concept trial that included 20 patients with pulmonary sarcoidosis. Findings showed that treatment with aviptadil was well tolerated and safe. Aviptadil also demonstrated clinically significant suppression of inflammatory processes in the lung, along with improvement of dry cough and exertional dyspnea.

The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals.


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The Company is also investigating aviptadil for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19.

References

  1. Relief announces receipt of U.S. FDA Orphan Drug designation for the use of RLF-100 (aviptadil) in the treatment of sarcoidosis. News release. Relief Therapeutics. Accessed August 3, 2021. https://www.businesswire.com/news/home/20210802005809/en/Relief-Announces-Receipt-of-U.S.-FDA-Orphan-Drug-Designation-for-the-use-of-RLF-100-aviptadil-in-the-Treatment-of-Sarcoidosis
  2. Pipeline: RLF-100TM (aviptadil). Relief Therapeutics. Accessed August 3, 2021. https://www.relieftherapeutics.com/pipeline.