Anthera Pharma (NASDAQ: ANTH)
Anthera Pharma is of to what looks like it will be a horrible day in the market today. While the opening bell hasn’t rung just yet, the stock is already experiencing massive declines in pre-market. Below, we’ll talk about what we’re seeing from the stock, why, and what we’ll be watching for with regard to ANTH ahead.
What We’re Seeing From ANTH
Anthera Pharma had a relatively strong day in the market, closing the day off at $2.01 per share after a gain of 2.03%. However, it doesn’t look like things are going to go quite as well today. In fact, the stock is down big in pre-market trading. Currently (8:13), ANTH is trading at $0.82 per share after a loss of 59.20% thus far today.
Why The Stock Is Falling
As usual, as soon as we were alerted by one of our trading tools that ANTH was making a run for the bottom, the CNA Finance team jumped into action. We started digging to see exactly what was causing the downward movement. In this particular case, it didn’t take long to uncover the news. Unfortunately, the declines are the result of a failed clinical study.
Yesterday, after the closing bell, Anthera Pharma announced top-line results from a clinical study known as SOLUTION. In the study, the company was working on treating cystic fibrosis patients with exocrine pancreatic insufficiency. Unfortunately, the study missed the CFA non-inferiority margin of the primary modified intent to treat analysis. As a result, the primary endpoint was missed. However, promising data was found through the trial.
What We’ll Be Watching Ahead
Moving forward, the CNA Finance team will be keeping a close eye on ANTH. In particular, we’re interested to see what the company does with the positive data from the study. While the primary endpoint was missed, there was good news that may be capitalized on down the road. We’ll keep a close eye on the news and bring it to you as it breaks!
UPDATE: Anthera Pharma’s (ANTH) Pain May Lead To AzurRx’s (AZRX) Gain
As CNA Finance pointed out just a short while ago, shares of ANTH are getting pounded following the disappointing results from its phase III study, SOLUTION, its pipeline candidate to treat EPI caused by cystic fibrosis.
While the results may be a huge setback for ANTH, companies like AZRX, which CNA Finance covered on Tuesday, may become prime beneficiaries of the poor SOLUTION results.
While ANTH softened the blow by stating that they “barely missed” the primary endpoints of a change in the coefficient of fat absorption (CFA) non-inferiority margin, the bottom line is that it was a miss. And, while the SOLUTION trial may have produced some varying degree of success, the delays that will accompany the requirements for additional filings and supplemental data sets, opens the door for competitors like AZRX to step in.
Is AZRX A Better Candidate to Treat EPI Caused By CF?
AZRX may clearly benefit from the SOLUTION miss, as AZRX has already produced some meaningful results in the clinic that demonstrate strong promise for AZRX technology using MS1819-SD, in its partnership with Mayoly Spindler. The trial is currently generating results from its on-going, open label study taking place in Australia and New Zealand.
AZRX is expected to release data related from its phase II, MS1819-SD trial in the first half of 2017. The trial is expected to enroll between 12-15 patients with EPI caused by CF in the first half of 2017, with periodic updates available consistent with the study protocol.
This dose escalation study will further evaluate safety and tolerability, adding a secondary endpoint that will investigate the efficacy and dose response in patients by analyzing the same CFA that was missed by ANTH. With the door now opened to a potentially less competitive field, AZRX is looking to advance MS1819-SD to treat over 100,000 patients in the United States with EPI caused by CP and an additional 30,000 patients with EPI caused by CF. The market may be lucrative, with estimates being that the treatment can generate over $820 million dollars in the United States and $1.5 billion dollars globally, according to the National Pancreas Foundation.
The AZRX Difference
Breaking away from the industry standard which uses a compound developed from the pancreas of pigs, AZRX is developing MS1819-SD, a recombinant enzyme that is derived from the yeast Yarrowia lipolytica, which is non-animal and entirely vegan in its makeup. Earlier studies have already shown that the AZRX compound can produce a profile to compensate for the pancreatic lipase deficiency that is common among CP patients.
The trial is a significant milestone for AZRX and the results published by ANTH may propel the MS1819-SD compound into the forefront as a viable and meaningful treatment to combat the debilitating affects of EPI caused by both CF and CP.
While the data is early on the AZRX front, the relative failure at ANTH does open the door to significant opportunity in several fronts, increasing interest from a market that is ripe for a better treatment.
CNA Finance will keep followers appraised of any new developments from both ANTH and AZRX, respectively.
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