Theravance Biopharma: Ampreloxetine Phase 3 Study In NOH Patients Fails To Meet Primary Goal

(RTTNews) - Theravance Biopharma, Inc. (TBPH), a company primarily focused on the discovery, development, and commercialization of organ-selective medicines, Wednesday said its Phase 3 study of ampreloxetine for the treatment of symptomatic neurogenic orthostatic hypotension or nOH did not meet the primary endpoint.

In pre-market activity on Nasdaq, Theravance Biopharma shares were losing around 38 percent to trade at $5.

The company announced top-line results from the Phase 3 randomized, double-blind, placebo-controlled multi-center Phase 3 study assessing the safety and efficacy of ampreloxetine compared to placebo.

According to the company, 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.

The company said it plans to present the results at a future scientific forum. In light of these results, the company said it will determe the appropriate next steps for Study 0170 and Study 0171.

Rick Winningham, Chief Executive Officer, Theravance Biopharma, said, "These are not the results we had hoped to achieve, especially given the clear unmet need for patients suffering from symptomatic nOH and the positive top-line four-week results from the Phase 2 study announced in 2018. We will continue to analyze the data to better understand the findings."