Anthera Pharmaceuticals Inc (NASDAQ:ANTH) announced the top line results of the SOLUTION clinical study in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). The study narrowly missed the CFA non-inferiority margin of the primary modified Intent to Treat (mITT) analysis; however, by additional pre-specified analyses of CFA (mITT-Baseline Observation Carried Forward and Per Protocol), Sollpura met the non-inferiority criterion.
The study also confirmed that the ratio of the three enzymes in Sollpura demonstrated an appropriate response in the coefficient of nitrogen absorption (CNA). CNA is a measure of protein digestion and absorption and is a key requirement of Anthera’s planned US FDA regulatory submission. Anthera expects to release data from the extension phase of the study in Q1 2017.
In analyzing the results of the SOLUTION study, patients’ ability to increase their doses during the study were hindered by time restrictions and amounts allowed per protocol, while other patients were prevented from increasing their dose due to the daily limit (10,000 lipase units/kg/day) for porcine pancreatic enzyme replacement therapies (PERTs). Sollpura was generally well tolerated compared to Pancreaze, although symptoms related to malabsorption were generally modestly more frequent in the Sollpura arm.
In addition to the challenges to dose escalation inherent in the design of the SOLUTION study, analytical techniques for measuring the activity of lipase enzymes based on duodenal pH of Cystic Fibrosis patients, indicate that Sollpura may have been under dosed versus the Pancreaze labeled dose.
Given the robust activity of Sollpura in this study, in the context of dose titration limitation and apparent reduced dosage activity, Anthera will initiate activities for an additional clinical study of Sollpura in patients with EPI due to Cystic Fibrosis, which Anthera expects will enable optimized dosing and dose titration. This study will provide investigators and patients the flexibility to adjust their Sollpura dose based upon malabsorption symptoms at any time during the study.
Anthera believes that these modifications in the study design will allow patients to achieve the optimal level of fat absorption as measured by CFA. The new study will begin in 1Q’17, and Anthera anticipates only a modest delay in the filing of the BLA around Q1 2018, as the new study will complete concurrently with the completion of required CMC activities.
“In the SOLUTION study, Sollpura nearly met the non-inferiority margin with respect to fat absorption, and met the statistical criterion for nitrogen absorption. The study data suggest that the deficiency in fat absorption may be addressed by small changes in study design, including more liberal dose adjustment. A need for alternative treatments remains for EPI patients who are unable to maintain appropriate nutritional health, especially those who seek soluble or non-porcine therapeutic options” said Michael Konstan, MD, Vice Dean for Translational Research at Case Western Reserve University School of Medicine.
“Although we are disappointed to narrowly miss the primary endpoint, we remain encouraged by the overall SOLUTION study results and look forward to releasing final data from and its 12 week extension phase in the future, the SIMPLICITY study and continuation of the open-label EASY study. We would like to thank the patients, investigators and study staff for their hard work and dedication to our study. We are most grateful for their commitment to our shared hope of developing new treatments for exocrine pancreatic insufficiency, and believe that the shortcomings of Sollpura in SOLUTION can be addressed in the new study that we plan to initiate in 1Q’17,” said William Shanahan, M.D., Anthera’s Chief Medical Officer.
Anthera will host a conference call to further discuss the data from the SOLUTION clinical study. (Original Source)
Shares of Anthera Pharmaceuticals closed today at $2.01, up $0.04 or +2.03%. ANTH has a 1-year high of $5.07 and a 1-year low of $1.33. The stock’s 50-day moving average is $1.88 and its 200-day moving average is $2.76.
On the ratings front, Anthera Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on November 11, H.C. Wainwright analyst Andrew Fein reiterated a Buy rating on ANTH. Separately, on the same day, Citigroup’s Yigal Nochomovitz maintained a Buy rating on the stock and has a price target of $6.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Yigal Nochomovitz have a yearly average return of 3.1% and a loss of -5.8% respectively. Fein has a success rate of 42% and is ranked #1157 out of 4290 analysts, while Nochomovitz has a success rate of 42% and is ranked #3919.
Anthera Pharmaceuticals, Inc. is a biopharmaceutical company, which is focused on developing and commercializing products to treat treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis. It develops phase 3 product candidates, which includes blisibimod and liprotamase.