An Israeli innovator says he has repurposed an erectile dysfunction treatment for coronavirus, and reports that it is showing promise, having significantly improved the health of six patients.
Jonathan Javitt has developed a form of aviptadil — a drug that is used almost exclusively for injection into the penis along with another drug phentolamine, to help men dealing with erectile disfunction — to treat severe coronavirus. This version of the drug for intravenous injection to COVID-19 patients, RLF-100, is now undergoing clinical trials in five American hospitals.
No results from these trials are available, but Javitt has released a report on six patients who received the drug outside of the trials, claiming that they had taken strong steps toward recovery.
“As far as I know, this is the first drug to treat COVID with which the [lung] X-ray gets better, the blood oxygen gets better, and cytokines drop very quickly,” he said. Cytokines are the small proteins that COVID patients sometimes produce in huge numbers, causing harm to their bodies.
“If you ask me whether this is the cure to COVID, my answer is that I don’t know, but it shows promise, and I hope so,” he told The Times of Israel.
Javitt, CEO of the US-Israeli NeuroRx Inc, partnered with Geneva-based Relief Therapeutics Holdings to produce the drug. An American doctor who moved to Israel, Javitt started working on it in March, when a capital fund that invests in both companies contacted him to say that it had the rights to the research, and wondered whether it might be useful in the fight against the coronavirus.
The research consisted of data on the safety and toxicology of aviptadil, which is essential for regulatory approval of any new drug based on it. Aviptadil is a synthetic form of vasoactive intestinal peptide (VIP), a short chain of amino acids that occurs naturally in the human body and protects the lungs.
Past research has illustrated that VIP, in addition to being used to treat erectile dysfunction, mostly in northern Europe, is a potent anti-inflammatory, though it is not currently in widespread use for this purpose. Javitt, with Yves Sagot of Relief Therapeutics, started exploring possible relevance to COVID-19, and made a formulation of the drug that they expected to work on the disease. They obtained permission from America’s Food and Drug Administration to carry out clinical trials, and also to administer it to some patients for emergency use.
Meanwhile, scientists at the Oswaldo Cruz Foundation in Rio de Janeiro had observed human lung cells infected by SARS-CoV-2 together with the drug, in vitro, in the laboratory.
Javitt said: “They reported that if you give the virus to human lung cells in a laboratory, the virus will enter the cells and kill them. If you give them this drug, it suppresses the replication of the virus and if the virus can’t make millions of copies of itself, it’s not harmful to you.”
As clinical trials for 70 people continue, 25 people have been given the drug under emergency use rules at Houston Methodist Hospital. Follow-up has been conducted on the first six people who received it on this basis, on average, 14 days after treatment. Javitt said that at the time of follow-up, all patients showed an improvement in blood oxygenation. He added that there was an average 56 percent reduction in inflammatory markers, and four out of six patients showed complete remission from respiratory failure.
Javitt said that despite his enthusiasm, he is realistic about the limitations of the research so far. “Of course, this is small number, and of course, testing that includes patients given placebos is needed,” he said.