March 30, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Norwood, Mass.-based Corbus Pharmaceuticals announced positive topline results from its Phase II trial of anabasum (JBT-101 or Resunab) in cystic fibrosis (CF).
The Phase II trial evaluated multiple doses of anabasum compared to placebo over a 16-week period in 85 patients. The drug hit is primary objective, which was an acceptable safety and tolerability profile at all doses. The company also cited that the twice daily 20 mg dose of anabasum caused a 75 percent drop in the annualized rate of pulmonary exacerbations that required IV antibiotics, compared to those on the placebo.
Some critics saw the trial results as less than positive.
John Carroll, writing for Endpoints News, said, “While Corbus touted the data as another sign of clinical progress, there was considerable chatter on Twitter attacking the results, which explains why shares are down 13 percent in pre-market trading.”
Adam Feuerstein, with TheStreet, wrote, “In this four-month study of cystic fibrosis patients, the Corbus drug failed to improve lung function compared to placebo. Overall respiratory symptoms, measured by a cystic fibrosis patient questionnaire, also showed no difference between anabasum and placebo.”
The company’s chief executive officer, Yuval Cohen, responded, “We don’t comment on stock movements but it is noteworthy that there is a sizable short position in our stock that is probably having a bad hair day this morning…”
No lung function data was data was provided. However, several biomarkers associated with inflammation found in sputum showed reductions in patients on anabasum compared to those on placebo. It was also pointed out that most of the patients in the trial were taking Orkambi, a combo therapy from Vertex Pharmaceuticals that improves lung function in CF.
“The finding of reduction in acute pulmonary exacerbations along with reductions in inflammatory cells and pro-inflammatory mediators demonstrate the potential of anabasum as a new therapeutic with a unique mechanism of action in cystic fibrosis,” said James Chmiel, the study’s primary investigator from Rainbow Babies and Children’s Hospital in Cleveland, in a statement.
The company indicated that after continued analysis of the data, it will work with its trial partners and the Cystic Fibrosis Foundation Therapeutics, Cystic Fibrosis Therapeutic Development Network and European Cystic Fibrosis Society Clinical Trials Network on its next steps.
“We are delighted that anabasum demonstrated a safety profile that was well tolerated by the CF patients in this study, especially given the challenges in safely targeting inflammation in CF,” said Barbara White, Corbus’ chief medical officer, in a statement. “In a study of just 12 weeks of active dosing, we are especially encouraged by the consistency in data that couple clinical benefit in pulmonary exacerbations with improvement in the inflammatory response in the lungs. We believe these findings reflect the underlying mechanism of action of anabasum in activating resolution of innate immune responses without immunosuppression.”
The drug was granted Orphan Drug Designation and Fast Track status by the FDA in 2015. In 2016, the European Medicines Agency (EMA) also gave it Orphan Drug Status.
Corbus are currently trading for $7.40. Shares have been on a wild ride the last five months. Shares traded on October 7, 2016 for $9.79, dropped on November 4 to $4.80, then jumped to $8.55 on December 23. On February 8, 2017, shares traded for $6.40, then hit $10.35 on March 20.
