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Theravance's Respiratory Disease JAK Inhibitor Enters Phase I

Theravance Biopharma, Inc. TBPH announced that it has dosed the first patient in a phase I study on its novel, inhaled, lung-selective pan-Janus kinase (JAK) inhibitor, TD-8236. The candidate is currently being developed to evaluate its potential for the treatment of various serious respiratory diseases.

The randomized, placebo-controlled phase I study on TD-8236 consists of two parts. The first will evaluate the candidate in single ascending doses (SAD) on healthy patients with the primary objective of measuring the safety and tolerability. While the second part will evaluate TD-8236 in multiple ascending doses (MAD), also assessing its safety and tolerability in patients with mild, stable asthma.

Notably, in preclinical studies, TD-8236 demonstrated long duration of action in the lung and low plasma levels, indicating that it can be developed as a once-daily treatment with minimal systemic exposure.

Shares of Theravance have lost 9.4% year to date compared with the industry’s decline of 8%.


TD-8236 is particularly designed as a dry-powder inhaler for the lungs with minimal systemic exposure. It is the second JAK inhibitor discovered by Theravance, which has entered a clinical study of late.

Last week, Theravance dosed the first patient in a phase II study on its gut-selective pan-JAK inhibitor, TD-1473, for the treatment of patients with Crohn's disease. TD-1473 is being developed in collaboration with Janssen, a subsidiary of Johnson & Johnson JNJ, for treating inflammatory intestinal diseases.

Theravance is also evaluating TD-1473 in a phase Ib program for addressing ulcerative colitis. Last month, the company announced data from the exploratory phase Ib study on TD-1473 for treating patients with moderate-to-severe ulcerative colitis.

Another interesting candidate in Theravance’s portfolio is TD-9855, which is currently under inspection for tackling the syndrome of symptomatic neurogenic orthostatic hypotension (nOH). In August, the company announced a positive top-line outcome from the phase II study on the candidate. Additionally, Theravance expects to initiate a registrational phase III study in late 2018 or early 2019.

Theravance Biopharma, Inc. Price and Consensus

Theravance Biopharma, Inc. Price and Consensus | Theravance Biopharma, Inc. Quote

Zacks Rank & Stocks to Consider

Theravance currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the same sector are BioSpecifics Technologies Corp BSTC and Hikma Pharmaceuticals Plc HKMPF, both sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

BioSpecifics’ earnings estimates have been revised 9.6% upward for 2018 and 16.8% for 2019 over the past 60 days. The stock has surged 31.6% year to date.

Hikma Pharmaceuticals’ earnings estimates have moved 15% north for 2018 and 10.1% for 2019 over the past 60 days. The stock has soared 59% so far this year.

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