Life Science Today 011 – AstraZeneca, Satsuma Pharmaceuticals, and Orasis Pharmaceuticals
Originally Published as The Niche Podcast
Introduction
Welcome to The Niche Podcast – Your weekly 5-minute rundown of the biotech, clinical research, and applied science industries. I’m your host, Dr. Noah Goodson. This week, vaccines and shark statistics, are noses the ultimate pipedream, and eye drops to replace eye-glasses.
AstraZeneca and Shark Statistics
AstraZeneca (AZ) placed their COVID19 vaccine AZD1222 clinical trial on hold last week. The move came as an unspecified safety concern emerged during the trial. While AZ did not confirm any specific reason for the hold, speculation has circulated that a patient experienced transverse myelitis. This condition can be caused by virally mediated immune responses and can result in weakness, inconstancy, and paralysis. While patients may experience recovery, for others the loss of function can be permanent.
AZ will not confirm or deny the specific condition that caused them to place their 18,000-participant phase III clinical trial on hold. However, it was certainly not headaches or fever. One of the major challenges with clinical trials and advancing medicines is the potential for serious adverse events. Whenever a participant is enrolled in a clinical trial, all adverse events must be reported. This means if you are taking a novel drug and have an unrelated heart-attack the sponsor must consider if that could be caused by the treatment. When trials are large, there will invariably be individuals who experience non-treatment related serious adverse events.
Since the trial went on hold last week, there have been a number of calls for increased openness and data disclosure around COVID19 clinical trials. On the one hand, this makes sense. Give everyone all the data, after all this is a public global health crisis. However, I would say this has a strong risk of creating shark-attack statistics. What do I mean by that? Last week a man was attacked and killed by a shark in Australia. This news was reported globally, perpetuating fear of death due to sharks. The problem is that there were only 64 unprovoked shark attacks in all of 2019, and only 2 of those were fatal. Considering the billions of hours spent by billions of people in sharks’ habitat throughout the year this makes being killed by a shark so unlikely as to be unrealistic to even consider.
Reporting every serious adverse event to the public, especially around vaccine trials, stands a major chance of misunderstanding. Consider that despite the fact that vaccines like MMR are shown to be safe and effective, there are millions of individuals out there insisting the mercury in vaccines is causing autism. Asking a global population who are already terrified to interpret complex data and make risk assessments is like asking people to rate their fear of a shark attack while at the beach.
Saturday, AZ announced they are re-opening the AZD1222 clinical trial and continuing the study.
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Primary Endpoints In Nasal Sprays
Clinical trials are designed with a primary endpoint. This is the statistical change that is required to occur for the trial to be successful. In early trials this endpoint is typically how well the drug is tolerated. Late stage clinical trial primary endpoints are usually a specific effect that may be time related. Last week, Satsuma Pharmaceuticals missed the primary endpoint on a phase three clinical trial for STS101, a migraine therapy. The trial delivered a drug, dihydroergotamine (DHE) that was known to help with migraines when injected, but this time they provided it through a more user-friendly nasal spray. While early trials showed promise, their primary endpoint of decreased symptoms 2-hours after therapy was not reached.
Nasal delivery of therapeutics continues to be a pipe dream for many drugs. When delivered to the upper portions of the nasal passages, drugs can be directly absorbed through the blood brain barrier. This can speed delivery and bypass specific problems that occur when treatments are taken orally. Numerous drugs have shown promise through this pathway in small clinical trials and preclinical animal models, only to be stymied during larger trials. It is not clear if this failure to function is due to variability in human population, hinderances from barriers like mucus, or simply spray solutions that do not deliver the spray high enough into the nasal passages. Satsuma shares lost near 80% of their value to close at $4.82/share on Friday.
Eye Drops For Presbyopia
The most common need for glasses with aging is Presbyopia, inhibiting people from seeing objects and details that are close. This effects nearly 2 billion people around the world. The condition is caused as the crystalline lens in the eye becomes less flexible. This loss of flexibility means the lens cannot be focused properly. The most common resolution is glasses.
The Israeli company Orasis announced they are raising a $30 million series C to advance an eye drop to treat Presbyopia to a phase III clinical trial and conduct pre-commercialization activities. Their product involves a simple eye drop that appears to “loosen” the crystalline structures in aging lenses, decreasing the need for glasses. If fully effective and well tolerated, certainly some of the 2 billion presbyopic patients will prefer a drop to glasses.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly 5-minute summary of top news in the biotech, clinical trials, and applied science industries. You can find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.
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Story References
Music by Luke Goodson
https://www.soundcloud.com/lukegoodson