Humanigen Inc (OTCMKTS: HGEN) is likely to see tremendous gains in the market when the opening bell rings. That’s because the company issued a press release this morning, announcing that it has made progress toward sending its COVID-19 treatment candidate into Phase III studies. Here’s what’s going on:
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HGEN Stock To Run On COVID-19 Phase III Announcement
In a press release issued early this morning, Humanigen said that it has submitted all initial protocal synopsis to the FDA in support of its plans to initiate a Phase III clinical study. This is a key step in pushing for the multi-center, United States-based, study.
If approved, HGEN said that the study will be a randomized, controlled, clinical trial. The trial will surround the use of lenzilumab as a both a preventative measure and a treatment for cytokine storm.
Cytokine storm takes place when the body has an excessive immune response to a virus, generally in the lungs. When this takes place, excessive immune cells and the cytokines that activate them rush to the lungs, leading to additional fluids on the lungs.
In COVID-19 patients, cytokine storm is known to lead to ARDS, or acute respiratory distress syndrome, as well as pneumonia. So, the ability to prevent or treat cytokine storm equates to the ability to improve patient chances of recovering from COVID-19.
In a statement, Dr. Cameron Durrant, CEO at HGEN, had the folllowing to offer:
Humanigen has pioneered the field of GM-CSF neutralization and, unlike others, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results. We have been working on prevention of cytokine storm for nearly three years. Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events, including in patients who are immunosuppressed or with severe asthma. Subject to discussion and agreement with regulatory authorities, we intend to progress as quickly as possible with this study.
The Strategic Advantages Here Are Hard To Ignore
While there are plenty of companies working to stop the spread of the coronavirus, in the world of treatments for the condition, Humanigen is far ahead of its compeition. You see, only a handful of companies have announced that they are working on treatments, rather than vaccines, for COVID-19. An even smaller number of companies has anything tangible, and when it comes to having a Phase III-ready asset ready for study, well, even fewer fit this criteria.
HGEN is one of those very few companies that has a Phase III-ready candidate. This alone is a strategic advantage. After all, in the face of a pandemic, speed to market is everything. With a candidate that’s ready to head into Phase III trials, speed is on the company’s side. However, that’s not the only strategic advantage here.
The truth of the matter is that the company has been studying, and working to fight against cytokine storms for some time now. Let’s face it, a Phase III candidate isn’t going to pop up over night.
In the past, HGEN has worked to prevent cytokine storms in cancer patients treated with CAR-T therapies, in asthma patients, and in patients in other populations. In previous clinical trials, the treatment has not only shown to be effective in both the prevention and treatment of cytokine storms, it has proven to uphold a compelling safety and tolerability profile.
Considering the fact that Humanigen has already displayed efficacy and safety in the prevention of cytokine storms, all the company needs to do now is prove that the same results can be seen in a population of high-risk COVID-19 patients.
The Market Opportunity Here Is Tremendous
Should all go well, the market opportunity for HGEN is tremendous. Think about it, when was the last time that you saw a pandemic shut down schools, put an end to events, and change life as you knew it. Chances are that your answer is NEVER.
The bottom line is that as the pandemic spreads, the need for treatment options is becoming more urgent. Of course, the world is pushing for vaccines as well, but vaccines aren’t the end all be all. After all, we have a flu vaccine, but more than 50,000 people die every year from the condition.
The truth is that we need a treatment, and as the pandemic spreads, demand for that treatment will only grow. With HGEN being well ahead of its competition, and having evidence that its lenzilumab candidate is effective in preventing and treating cytokine storm, this is a stock that investors should not ignore.
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