FDA grants IND “Study May Proceed” for COVID-19 trial to NeuroRx, Inc. in partnership with RELIEF THERAPEUTICS (SIX:RLF) for treatment of Acute Respiratory Distress

29 March 2020

Aviptadil is a patented form of Vasoactive Intestinal Polypeptide (VIP)
that has previously shown promise in treating ARDS

Geneva, March 29, 2020

  • Coronavirus (COVID-19) death is primarily caused by Acute Respiratory Distress Syndrome (ARDS), in which severe inflammation causes the lungs to fill with fluid and even mechanical ventilation is unable to maintain life. The syndrome is caused by a Cytokine Storm unleashed by viral particles.
  • VIP is known to have potent anti-cytokine effects in numerous animal models and in phase 1 and phase 2 human studies
  • Both FDA and EU have granted orphan drug status to Relief Therapeutics for the development of Aviptadil (VIP) in ARDS

The US FDA has issued a “Study May Proceed” letter to NeuroRx, a Delaware Corporation within 24 hours of NeuroRx’s IND application. In partnership with Relief Therapeutics (SIX:RLF) NeuroRx is now recruiting study sites and pharmacies to commence a phase 2 trial of RLF-100 (Aviptadil) in the treatment of Acute Respiratory Distress in patients infected by the COVID-19 coronavirus. NeuroRx, Inc. is a privately held, drug development company that has previously demonstrated success in developing innovative drugs under FDA Fast Track, Breakthrough Therapy, and Special Protocol Agreement programs. Relief, headquartered in Geneva, Switzerland, previously partnered with Biogen (Nasdaq:BIIB) to develop Aviptadil for the treatment of pulmonary hypertension.

Acute Respiratory Distress Syndrome (ARDS) in COVID-19-infected patients is caused by a “cytokine storm” in the lungs, in which the virus triggers inflammatory molecules called “cytokines,” which cause the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen, even in the setting of mechanical ventilation. Even with access to ventilators and maximal intensive care, half of those with COVID-related ARDS die. In a phase 1 trial of Aviptadil performed by Sami Said, MD, under FDA IND in the early 2000’s,[1] 7 of 8 patients treated with intravenous VIP were successfully weaned from mechanical ventilation and six of those patients left the hospital alive. The results demonstrated a meaningful decrease in TNFa (alpha), a known inflammatory cytokine and consistent improvement in oxygenation. VIP is a naturally synthesized peptide which is 40% concentrated in the lungs and which has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation. VIP has shown the ability to protect the lung even from extreme insults such as hydrochloric acid. It has a 20-year history of safe use in humans in trials of sarcoidosis, pulmonary fibrosis, and pulmonary hypertension, and is marketed in Europe as a local injection to treat erectile dysfunction. At an FDA public hearing in 2016[2], it was noted that more than 8,000 prescriptions for VIP were filled by a compounding pharmacy to treat a chronic inflammatory condition without any reported adverse events.

Relief Therapeutics holds FDA and EU orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patent[3] for formulation of Aviptadil and proprietary manufacturing processes for its synthesis.

The trial will be overseen by an independent Data Safety Monitoring Board led by Prof. Alfred Sommer, MD, MHS, Dean Emeritus of the Bloomberg School of Public Health, Prof. Michelle Williams, Dean of the Harvard Chan School of Public Health, and Hon. Andy Harris, M.D., M.H.S. who represents Maryland’s first congressional district and is a practicing anesthesiologist.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF.

[1] FDA IND 52,088

[2] FDA Pharmacy Compounding Advisory Committee, November 3, 2016

[3] US 8,178,489 Formulation for Aviptadil