COVID-19 Update #37 for 8/21/2020

COVID-19 Vaccines
 
Sinopharm has priced its COVID-19 vaccine at $145 for two doses.
 
COVID-19 Antibodies
 
Regeneron has signed an agreement with Roche to increase manufacturing capacity and distribution of REGN-COV2, Regeneron’s mixture of two monoclonal COVID-19 antibodies. Roche will triple the manufacturing capacity for REGN-COV2 and handle distribution outside the U.S.
 
Aviptadil
 
Aviptadil (RLF-100) is a synthetic human Vasoactive Intestinal Polypeptide. Aviptadil blocks the replication of the SARS coronavirus in human lung cells and monocytes. The drug has been in clinical trials since 2001 and was unsuccessfully evaluated for Acute Respiratory Distress Syndrome and Pulmonary Arterial Hypertension.

• The FDA has granted aviptadil Fast Track status 
• Aviptadil is available under an Expanded Access Protocol (NCT04453839) for the treatment of patients with COVID-19 and Respiratory Failure
• NeuroRx is evaluating inhaled aviptadil for the treatment of moderate and severe COVID-19 patients who have not yet developed respiratory failure in a 288 patient, Phase II/III trial (NCT04360096)
• NeuroRx is evaluating intravenous aviptadil for the treatment of hospitalized patients with a Critical COVID-19 infection and respiratory failure in a 144 patient, Phase II trial (NCT04311697)
• An unpublished case study describes a double lung transplant patient that developed a COVID-19 infection with respiratory failure. The patient received three intravenous infusions of aviptadil and saw improvement within 24 hours of the third infusion. The patient was discharged home on room air one week later.
• NeuroRx  has said that similar results to the case study have been seen in 15 additional patients treated with aviptadil under the Expanded Access Protocol.​
  

Tradipitant
 
Tradipitant is a neurokinin-1 receptor (NK-1R) antagonist being developed by Vanda Pharmaceuticals for the treatment of diabetic gastroparesis, motion sickness, and atopic dermatitis. By inhibiting NK-1R, tradipitant is thought to decrease inflammatory lung injury associated with severe or critical COVID-19 pneumonia.

• Vanda Pharmaceuticals reported that interim results from 60 COVID-19 patients enrolled in the 28-day, 300 patient, Phase III, ODYSSEY trial (NCT04326426), where a 14-day treatment with tradipitant reduced the time to improvement after 7-days compared to placebo. Despite a numerical advantage, the improvement was not significant at 28 days (10 days vs 28 days), likely due to the small number of patients. There was also no statistical difference between tradipitant and placebo in the overall percentage of patients improving (57% vs 50%) or mortality (14.2% vs 16.6%).