Today was a big day in the biotechnology space for a number of clinical trials. Here is a look at which companies put out reports and the impact of each on the company in question.
This first one is rooted in the release of some data from a phase 3 trial of a drug called Sollpura. Anthera is trying to complete a program designed to show that this drug can be safe and effective when used as a treatment for patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis.
EPI is a condition that arises when a patient has a lack of pancreatic enzymes which, in turn, arises when thick mucus in the pancreas stops the pancreatic enzymes in question entering the small intestine. Cystic fibrosis is a real driver behind the buildup of thick mucus and, as such, has become the second most common cause of EPI in the US. Right now, there’s very little in the way of treatment available to patients suffering from this condition and this becomes even truer when you narrow in on the portion of EPI sufferers that also suffer from CF.
With Sollpura, Anthera is trying to change this.
The drug is a pancreatic enzyme replacement therapy derived from non-pig enzymes, the first of its type. Most of the time (in fact all of the time in the US), this sort of therapy derives from pigs, which can’t be used for certain patients due to religious restrictions.
If Anthera could get its investigational drug to market, then, it would not only have been able to present a fresh alternative to the current standard of care treatments (which are lacking in efficacy and safety) but also it would be able to target a market that currently has limitations based on religious restrictions.
So what did the data tell us?
Well, unfortunately, the drug doesn’t seem to work.
As per the latest release, the drug failed to hit its primary endpoint of efficacy and, while there don’t seem to be any real safety concerns associated with administration if it doesn’t work it doesn’t work.
So, what comes next?
Well, this looks like it is the end of the line for Sollpura, at least in this indication. Anthera has indicated that it intends to drop the program and markets are responding accordingly – at the close of play post-announcement, Anthera’s shares are down 81%.
Advaxis just announced that the FDA has placed a clinical hold on one of its lead development programs. The trial in question is a phase 1/2 combination study of a drug called axalimogene filolisbac as used in combination with already approved IMFINZI (durvalumab), which the company is investigating as a potential therapy for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer.
This is a very severe cancer type and it is one for which the currently available treatments fall dramatically short as compared to some other oncology subtypes, and Advaxis was hoping that it could improve on the current standard of care therapies by combining its asset with those already in existence.
So, what happened?
Well, according to the release, the FDA got word that a patient has died in the trial and has halted the study on the back of this patient death.
Of course, that a patient has died in a clinical trial (and especially when you consider that the trial is a severe oncology trial) doesn’t necessarily mean that it is the drug that has caused the death – often the opposite is true and it is the disease that has caused the death as opposed to the investigation asset.
However, in some instances, and especially as relates to combination trials, the FDA will place an immediate hold on anything that looks like it might be drug related so as to assess the risk of further drug-induced danger before continuing.
In other words, this is more of a precaution than anything else, but markets are still trading down on Advaxis based on the uncertainty surrounding the news. The company dipped around 25% after hours on Monday and will open on Tuesday in and around $2.21 per share.
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