- RESULT, pivotal Phase 3 Study of Sollpura, is expected to screen the first patient in May
- Favorable trends on weight, height, and body mass index (“BMI”) from the Extension Period of the SOLUTION Study of Sollpura
- Completion of dosing in the Phase 2 BRIGHT-SC Study of blisbimod in patients with IgA Nephropathy
- Closing of initial $15 million public offering
HAYWARD, Calif., May 10, 2017 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a business update and reported financial results for the first quarter ended March 31, 2017.
Recent Developments and Business Highlights:
Sollpura™ (liprotamase) for the treatment of Exocrine Pancreatic Insufficiency (“EPI”)
- Phase 3 RESULT study expected to screen the first patient in May
The Phase 3 RESULT study, which is expected to screen the first patient in May, is a pivotal, 4-week study designed to evaluate the non-inferiority of Sollpura at individualized doses compared to approved, porcine-extracted, enteric-coated pancreatic enzyme replacement therapy (“PERT”). The study intends to enroll patients (N˜150) with exocrine pancreatic insufficiency due to cystic fibrosis who are well controlled on stable, porcine-extracted PERTs at screening. The primary efficacy variable will evaluate the change from baseline in the coefficient of fat absorption following 4 weeks of treatment with either Sollpura or Pancreaze. Patients randomized to Sollpura or Pancreaze may undergo further dose adjustments based upon gastrointestinal signs and symptoms to identify their individualized, optimized dose. Anthera believes that this optimized dosing paradigm may correct for expected differences in solubility between the lipases in Sollpura and porcine PERTs in the more acidic duodenal pH of patients with cystic fibrosis. After 4 weeks of treatment, patients randomized to Sollpura will be followed for an additional 20-Week extension period (total of 24 weeks on study) for additional assessments of weight, height, BMI, and safety. Topline data, which will be analyzed based on the 4-week treatment period, is expected at the end of 2017 or early 2018. - Extension Period of the Phase 3 SOLUTION study demonstrated favorable trends
On March 29, 2017, Anthera announced favorable trends observed from the Extension Period of the Phase 3 SOLUTION study. In the full study population of the Extension Period, Sollpura demonstrated comparable maintenance to Pancreaze in regards to weight, height, and BMI. In pediatric patients less than 17 years of age, the key age group for growth and development, similar trends in weight and height were observed. As in the Primary Treatment Period, Sollpura was well tolerated throughout the Extension Period.
Blisibimod for the treatment of IgA Nephropathy
- Completion of dosing in the Phase 2 BRIGHT-SC
On April 10, 2017, Anthera announced the completion of dosing in the randomized, double-blind, placebo controlled, Phase 2 BRIGHT-SC study of blisibimod in patients with IgA nephropathy (“IgAN”). After Week 24, patients were given the opportunity to continue blinded treatment for up to 104 weeks, discontinue treatment but continue to be followed, or discontinue from the study. Most patients, 42 of 57, completed at least 60 weeks of evaluation and 21 completed assessments through at least 104 weeks. Topline data from the BRIGHT-SC study is expected in Q3 2017.
