ZYESAMI
(aviptadil, previously RLF-100) is being considered for treatment of Respiratory Failure in critically ill patients with Covid-19.
Zyesami is a synthetic form of Vasoactive Intestinal Peptide (VIP) consisting of 28 amino acids, which was first discovered in 1970. Although initially identified in the intestinal tract, human VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs.
NRx Pharmaceuticals $NRXP give a presentation today July 21st, 2021 of how randomized phase 2b/3 trials show patients treated with Zyesami are significantly less likely to experience IL-6 Cytokine rise, improving survival and recovery from respiratory failure compared to patients receiving a placebo.
Who Owns the Patent for Zyesami?
This has bearings on the patent holder Relief Therapeutics, you can see their agreement with NRx here. Essentially Relief Therapeutics holds 70.67% overall of the patent profits, a bit less if you consider the U.S. is 50% split between the two companies.
Relief and NeuroRx have taken steps to set up the manufacturing of RLF-100 to prepare for potential future commercialization. For the treatment of severe Covid-19 in ICUs with Delta, more EUA approved treatments by the FDA is required. It's looking like Zyesami might be among the most promising of dozens of potentials.
Dosing of the first patient in a phase 3 clinical trial of ZYESAMI (aviptadil acetate) was announced by the National Institutes of Health (NIH) in April, 2021.
The study carried out across the United States as part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to prioritize and accelerate development of the most promising COVID-19 treatments. NeuroRx is designated by NIH as an industry partner in this initiative, however the main beneficiary is a little known Swiss biotech company, ticker $RLFTF (OTC).
In the last year $RLFTF is up 460% and it could be due for another rise if this becomes more mainstream treatment for serious cases of the Delta variant where cases are climbing already in July, 2021.
Dr. Anthony Fauci elaborated on the need for new COVID-19 therapeutics and discussed this trial in a White House press briefing on April 23, 2021. He offered the following comment on the inclusion of ZYESAMI amongst promising COVID-19 therapies, "There's a clinical trial of therapeutics for severely ill individuals. It's randomized. It's blinded. Its placebo controlled. And it's going to study Zyesami – which is a synthetic version of a vasoactive peptide – and remdesivir alone and in combination against a placebo."
On September 21, 2020, Relief and NeuroRx announced the completion of their partnership agreement for the commercialization of RLF-100 worldwide. The progress made in the last year alone of Zyesami has been significant and it appears to be on course to become a standard treatment in 2022 for cases of serious hospitalization especially as Delta's viral load is far higher than the original strain of Covid-19.
Zyesami Presentation by NeuroRx
The presentation identifies a statistically significant effect of ZYESAMI (aviptadil) in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. In the recently-completed phase 2b/3 trial, patients treated with placebo experienced a statistically significant elevation in interleukin 6 (IL-6) cytokine levels, whereas those treated with ZYESAMI had a minimal increase in IL-6. Change in cytokine level was a prespecified endpoint of the study.
In a previously reported study, at 28 days, patients treated with ZYESAMI demonstrate 35% higher likelihood of recovery from respiratory failure with continued survival compared to patients treated with placebo (Hazard Ratio 1.53; P=.08).
NeuroRx has seen its stock price being very volatile on the news, ticker $NRXP. It's hard to say for sure but it appears that Zyesami is the first reported therapy to show better recovery and survival in Covid-19 patients with respiratory failure.
Zyesami Likely Reduces Mortality from Covid-19 in ICUs
So what kind of a future can the on-boarding of Zyesami expect? Health regulators continue to prioritize therapies for COVID-19 which help block the impact of IL-6 cytokines in patients with COVID-19. The anti-cytokine effect of ZYESAMI was additionally associated with a significant decrease in 60-day mortality.
As of the summer of 2021, their data has been submitted to the FDA as part of their EUA application for Zyesami and approval could come before 2022, possibly even soon. Dr. Javitt is of course advocating for its approval. Under the terms of the agreement, NeuroRx will lead commercialization in the United States, Canada, and Israel, while Relief will lead commercialization in Europe and the rest of the world. However, Relief still gets 50% of the profits in the NeuroRx zones.
The presentation is for the Disease Prevention and Control Summit America 2021(virutual) based out of New York City. The impact of Zyesami on survival and recovery and a measurable biologic change in cytokine levels provides a basis for seeking a biomarker-based regulatory path as envisioned by the 21st Century Cures Act. This suggests the patent holder Relief Therapeutics could receive a Covid-19 stock boost when EUA is approved and in anticipation of the event.
It's always seemed to me a much more interesting treatment as compared to the meme stock of $OCGN where Covaxin vaccine would not be used much in the U.S by Ocugen. In the era of Delta and its under-estimated impact, Relief as a covid-19 stock could prove to be quite extraordinary in the next two to three years. The use of Zyesami will likely be a mainstream occurring in the near future in ICUs.
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