The Doctrine of Equivalents may be on Relief’s side but time may not. NRXP wants “all things” lungs, assurances that the clinical trials on these 6 indications will be theirs 50-50:
In the coming year, we intend to initiate clinical trials for the following indications:
1- COVID “longhauler” syndrome: millions of Americans continue to suffer from reduced respiratory capacity and require home oxygen in order to maintain adequate blood oxygen levels.
2- Sarcoidosis: this chronic lung disease affects 185,000 Americans and causes pulmonary disability and death in 1% to 5% of those affected. The FDA has recognized Sarcoidosis as an orphan disease.
3- Acute Respiratory Distress Syndrome (ARDS): this is the condition that Prof. Sami Said first treated in the last years of his career, together with our Principal Investigator, Dr. J. Georges Youssef of Houston Methodist Hospital. Seven of the 8 patients they treated at Stonybrook University Hospital survived the Intensive Care Unit and 6 successfully left the hospital.
4- Checkpoint inhibitor pneumonitis: one of the most promising developments in cancer chemotherapy is the advent of checkpoint inhibitor drugs, of which Keytruda® (pembrolizumab) is the best-known example. While these drugs have shown promise in previously hopeless malignancies, they cause a highly unpleasant lung inflammation (pneumonitis) that is a challenge for patients and their families. There are reports in the medical literature of substantial relief being achieved with inhaled aviptadil.
5- Preservation of donor lungs both before and after transplant: There is a substantial pre-clinical literature on the effect of aviptadil in protecting donor lungs both while outside the body and after transplant. Dr. Youssef has treated some lung transplant patients under an investigator-sponsored IND with encouraging results.
6- Chronic Obstructive Pulmonary Disease (COPD): Highly provocative data have been shared with us regarding the potential for aviptadil to improve symptoms in patients with advanced COPD. More than 15 million Americans suffer from COPD and treatment at this time is largely confined to custom-compounded off-label use of inhaled steroids and bronchodilators. Our manufacturing partner, Nephron Pharmaceuticals, is one of the nation’s largest suppliers of custom inhaled medicines.
I could be wrong.
