The other shoe drops for Theravance

Snippets

After the failure of Theravance’s gut-selective Jak inhibitor izencitinib last month the company’s hopes hinged on getting a result with ampreloxetine in neurogenic orthostatic hypotension. Today the latter project was also revealed to be a dud, and the group has slashed its headcount and R&D efforts in response. Such an outcome was entirely predictable given unconvincing phase 1/2 ampreloxetine data, and a restructuring had also been foreseen by Leerink analysts. More surprisingly, Theravance does not seem to have learned its lesson: the group’s core assets now include the inhaled Jak inhibitor nezulcitinib, which is in development for acute lung injury despite recently failing a Covid-19 trial. More sensible, if unexciting, is a focus on the approved respiratory products Trelegy, on which Theravance receives royalties from Glaxosmithkline, and Yupelri, sold in partnership with Viatris. Theravance hopes that its streamlining will allow it to become “sustainably cash flow positive” by the second half of 2022, but many investors are not hanging around to find out. The company, already worth less than half of what it was at the start of the year, fell another 22% this morning.

The new-look Theravance
Project Description Setting Trial details
Still in play
Nezulcitinib (TD-0903) Lung-selective Jak inhibitor Acute lung injury Failed ph2 in Covid-19, development continues in acute lung injury
Unnamed Dry-powder Jak inhibitors Asthma Preclinical
Out of favour
Ampreloxetine (TD-9855) Norepinephrine reuptake inhibitor Neurogenic orthostatic
hypotension
Failed ph3 Sequoia; ph3 Redwood being closed out
Izencitinib (TD-1473)* Gut-selective Jak inhibitor Ulcerative colitis, Crohn's  Failed ph2b Rhea in UC; ph2 Dione in Crohn's reads out Q4'21/Q1'22
TD-8236 Lung-selective Jak inhibitor Asthma Failed in ph2a asthma allergen challenge trial; development "paused"
TD-5202* Gut-selective Jak inhibitor Coeliac disease Ph1 in healthy volunteers completed; deprioritised
Inhaled ALK5i Inhaled Alk5 inhibitor Idiopathic pulmonary fibrosis Ph1; presumed deprioritised
*Being developed in partnership with J&J. Source: Evaluate Pharma & clinicaltrials.gov.

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