Phase 2 Trial of Inhaled Therapy Aviptadil OK’d in Germany
The clearance by the German medical regulatory authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) was given to AdVita Lifescience, the original developer of aviptadil, which was recently acquired by Relief Therapeutics.
“Receiving regulatory clearance to begin a phase 2 clinical trial of inhaled aviptadil marks another clinical milestone for Relief and our subsidiary, AdVita,” Raghuram Selvaraju, chairman of the board of Relief, said in a press release.
“Aviptadil is believed to be the only known experimental drug that could potentially suppress sarcoidosis-associated cough, one of the major symptoms reducing quality of life in this patient population,” Selvaraju said.
Sarcoidosis is a highly variable inflammatory disease that can lead to the formation of small abnormal lumps of cells — nodules called granulomas — in virtually any organ in the body, but most commonly the lungs.
Aviptadil is an artificial form of a hormone called vasoactive intestinal peptide, or VIP, that is mainly concentrated in the lungs and has potent anti-inflammatory, immunoregulatory, and anti-viral properties. In short, the hormone can block inflammation and viruses, and help to regulate the body’s immune responses.
A previous proof-of-concept Phase 2 clinical trial, named Avisarco II (2017-004219-37) and also conducted in Germany, had evaluated the safety and effectiveness of the inhaled therapy in 20 adults with pulmonary sarcoidosis associated with cough.
The results showed that aviptadil was generally safe and well-tolerated, significantly halted inflammatory processes in the lung, and led to a reduction of sarcoidosis-relevant biomarkers. Aviptadil also lessened patients’ dry cough and shortness of breath during exercise.
Those findings led the U.S. Food and Drug Administration to grant aviptadil orphan drug designation, a status meant to accelerate the clinical development and review of candidate therapies showing potential for rare diseases. The designation provides certain benefits, such as exemption from FDA application fees, and seven years of market exclusivity in the U.S. upon approval.
The upcoming randomized, double-blind, multicenter clinical trial is designed to confirm the therapy’s benefits in a larger group of patients.
“We look forward to initiating this trial and to further exploring the clinical utility of aviptadil across multiple pulmonary indications,” Selvaraju said.
Relief’s partner, NeuroRx, also is testing aviptadil, both as an inhaled and infused therapy, for the treatment of severe COVID-19 respiratory complications.