Theravance tanks as Phase III ampreloxetine fails

US drug developer Theravance Biopharma’s (Nasdaq: TBPH) shares fell as much as 39% and closed yesterday down 15.8% at $6.77, after the company released disappointing trial results for its ampreloxetine and followed this with an announcement on refocussing its portfolio and reducing staff numbers.

The Phase III randomized, double-blind, placebo-controlled multicenter study assessing the safety and efficacy of ampreloxetine compared to placebo for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) did not meet its primary endpoint.

The majority of treatment-related adverse events were mild or moderate in severity. Serious adverse events occurred in two patients on placebo and four on ampreloxetine and none were considered related to the study drug; no deaths were reported. There was no signal for supine hypertension.