Shares of Italian biotech BioXell SpA fell 37 percent on Thursday after the company reported disappointing top-line data from its Phase IIb trial of Elocalcitol for overactive bladder.
In the double-blind, placebo-controlled, 257-patient study, Elocalcitol failed to significantly reduce bladder volume at the first involuntary contraction, the primary endpoint of the study.
The drug did, however, significantly improve incontinence episodes in a subgroup of patients, and it significantly improved secondary endpoint measures including bladder volume at the first desire to void and patient's perception of bladder condition.
Nonstatistically significant improvements also were seen in secondary endpoints including urodynamic parameters and symptom severity.
BioXell plans to further review the data with its advisors. CEO Francesco Sinigaglia said in a press release that the "results on the primary endpoint are disappointing" but that he remains encouraged by the secondary endpoint data.
Elocalcitol is a vitamin D3 analogue, one of an estimated 300 such analogues in BioXell's library.
The drug previously met its primary endpoint of arresting prostate growth in a Phase IIb trial for benign prostatic hyperplasia, and BioXell had planned to start working with the FDA on pivotal trial plans last year. But regulatory progress was delayed when chief medical officer Enrico Colli resigned last July. Laurence Howard Skillern, formerly of Pfizer Inc.'s research and development team, took over the CMO position in October and got the BPH program back on track.
Elocalcitol also was being studied for a third indication: male infertility. But given financial constraints and the disappointing data from the overactive bladder trial, BioXell decided to halt its ongoing Phase II infertility study.
BioXell reported €43.6 million (US$57.3 million) in cash at the end of 2008 after burning through €13.7 million (US$18 million) during the year.
"In light of the top-line OAB results and the current financial climate, our short-term objective is to focus our spending very carefully and ensure strict cost control," Chief Financial Officer Niels Ackermann said in a press release.
To that end, BioXell also temporarily shelved BXL746, another vitamin D3 analogue that had been poised to begin clinical trials for the prevention of postsurgical adhesions.
The company added that it currently is evaluating all of its strategic options, including merger and acquisition activities.
Earlier in its pipeline, BioXell has a preclinical antibody targeting TrkA for pain and a preclinical TREM-1 (Triggering Receptors Expressed on Myeloid cells) program for sepsis and inflammatory bowel disease.
Shares of Milan, Italy-based BioXell (SIX:BXLN) fell CHF1.74 to close at CHF2.96 on Thursday.