Dive Brief:
- Small biotech Aquinox Pharmaceuticals has laid off half of its workforce and closed its office in San Bruno, California, as it works to trim operating costs after the failure of its only clinical-stage drug candidate last month.
- All further development work for that candidate, called rosiptor, has been halted and Aquinox is evaluating its options for moving forward. The company reported about $93 million in cash, equivalents and short-term securities on its balance sheet as of March 31, 2018.
- Aquinox stock fell by roughly 85% in value after the biotech reported in June that rosiptor didn't outperform placebo in treating interstitial cystitis in a Phase 3 study. Shares now trade at just over $2.70 apiece.
Dive Insight:
Biotechs are rarely so frank when disclosing a clinical setback. When Aquinox revealed its Phase 3 study fell short of goal, the company didn't bother with the pretense of searching for a silver lining to the results.
"We have thoroughly reviewed the results and believe it was a robust and well-conducted study and the results are definitive," said Aquinox CEO David Main on a conference call held June 27.
"We have conducted a number of sensitivity, subpopulation and secondary endpoint analyses and none demonstrate the benefit of rosiptor over placebo."
The study, called LEADERSHIP 301, enrolled 433 patients to test whether rosiptor could reduce maximum daily bladder pain scores in female subjects compared to placebo. At 12 weeks, the difference between the treatment and control arms in average change from baseline was not statistically significant, turning up a clearly negative p value of 0.41.
"The patients improved from start to finish but it didn't matter whether you took placebo or drug," Main said.
As a result, Aquniox halted further development activities, including a Phase 2 study testing rosiptor in male patients with chronic prostatitis syndrome that was initiated earlier in June.
The layoffs, which affected 30 employees, and closure of the company's San Bruno office will result in $2.5 million of restructuring charges, Aquinox said.
It's unclear what will happen to a recently inked partnership with Japanese pharma Astellas, which agreed to pay Aquinox $25 million in exchange for rights to rosiptor in Japan and several other Asia Pacific countries.
Shares in Aquinox fell by more than 8% in Tuesday trading on news of the restructuring.