Theravance Biopharma Inc.

TBPH

Held by 2 specialist biotech funds

2 funds opened new positions. Next phase2 readout (TD-1211): Oct 2010. Short interest: 5.2% of float.

BiotechnologyCEO: Rick E. WinninghamIPO: 2014Website ↗

Theravance Biopharma, Inc., a biopharmaceutical company, develops and commercializes medicines in the United States. It offers YUPELRI, an once-daily, nebulized long-acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease (COPD); and Ampreloxetine an investigational, once-daily norepinephrine reuptake inhibitor, Which is in Phase 3 clinical trials for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA). It has a strategic collaboration agreement with Viatris Inc. for the development and commercialization of revefenacin, including YUPELRI inhalation solution. Theravance Biopharma, Inc. was incorporated in 2013 and is based in South San Francisco, California.

Catalysts

Phase 2Q2 2007TD-1792Staphylococcal Skin InfectionNCT00442832

Primary: Clinical response (7 to 14 days after last antibiotic dose)Enrollment:203/203Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2008400 microgrammes GSK961081Pulmonary Disease, Chronic ObstructiveNCT00674817

Primary: Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h. (Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1)Enrollment:45/45Sites: 4RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q4 2010TD-1211Healthy, Opioid-induced ConstipationNCT01040637

Primary: Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation (Daily pre and post dose assessments throughout the duration of the study period)Enrollment:102/102Sites: 3RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q2 2012TD-1211Opioid-induced Constipation (OIC)NCT01333540

Primary: Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211 (Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks)Enrollment:69/69Sites: 1RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q2 2012TD-1211Opioid Induced ConstipationNCT01401985

Primary: Safety and tolerability of TD-1211 (14 days)Enrollment:95/95Sites: 1NON_RANDOMIZED, SINGLE, TREATMENT

Phase 2Q2 2012TD-1211Opioid Induced ConstipationNCT01459926

Primary: Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment (Between weeks 2 and 5)Enrollment:217/217Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q4 2013TD-9855Attention-Deficit/Hyperactivity Disorder, ADHDNCT01458340

Primary: Change From Baseline in AISRS Total Score at Day 42 (Baseline and Day 42)Enrollment:295/295Sites: 17RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q4 2013velusetrag dose 1GastroparesisNCT01718938

Primary: Gastric emptying half time (GE t1/2) (From baseline to week 5)Enrollment:34/34Sites: 9RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2014TD-9855 Group 1FibromyalgiaNCT01693692

Primary: Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries (Baseline and Week 6)Enrollment:392/392Sites: 34RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q2 2017VelusetragGastroparesisNCT02267525

Primary: 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score (At Week 4)Enrollment:233/233RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q3 2018TD-9855Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Pure Autonomic FailureNCT02705755

Primary: Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) (7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing))Enrollment:34/34Sites: 6RANDOMIZED, SINGLE, TREATMENT

Phase 2Q3 2020TD-8236AsthmaNCT04150341

Primary: Area Under the Curve of Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14 (Day 14 of treatment period: 3 to 8 hours after allergen challenge)Enrollment:24/24Sites: 2RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q2 2021TD-0903Acute Lung Injury (ALI) Associated With COVID-19, Lung Inflammation Associated With COVID-19NCT04402866

Primary: Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28 (Randomization to Day 28)Enrollment:235/235Sites: 24RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q3 2021ampreloxetineSymptomatic Neurogenic Orthostatic HypotensionNCT03750552

Primary: Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4 (Baseline and Week 4)Enrollment:195/195Sites: 125RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ4 2021TD-1473 Dose AUlcerative Colitis (UC)NCT03758443

Phase 3NegativeQ4 2021TD-1473 Dose AUlcerative Colitis (UC)NCT03920254

Phase 3NegativeQ4 2021ampreloxetineSymptomatic Neurogenic Orthostatic Hypotension, MSA, Parkinson's Disease (PD)NCT03829657

Phase 3NegativeQ4 2021ampreloxetineSymptomatic Neurogenic Orthostatic HypotensionNCT04095793

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Day 1 up to a maximum of 749 days)Enrollment:110/110Sites: 55NA, TREATMENT

Phase 2NegativeQ4 2021Crohn's DiseaseNCT03635112

Phase 3Q1 2026AmpreloxetineSymptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System AtrophyNCT05696717

Primary: Change in OHSA composite score at Week 8 during the double-blind RW period (8-week randomized withdrawal period (Week 12 to Week 20))Enrollment:Target 102Sites: 79RANDOMIZED, QUADRUPLE, TREATMENT

Theravance Biopharma Inc.

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