Research Desk Line-up: Champions Oncology Post Earnings Coverage
LONDON, UK / ACCESSWIRE / August 4, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Theravance Biopharma, Inc. (NASDAQ: TBPH), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=TBPH. The Company announced on August 02, 2017, positive results from a 12-week, Phase-2b study of Velusetrag (TD-5108), an oral investigational drug in development for the treatment of patients with diabetic and idiopathic gastroparesis, demonstrating statistically significant improvements in gastroparesis symptoms and gastric emptying in patients receiving 5 mg of Velusetrag compared to placebo. Additionally, Velusetrag was shown to be generally well-tolerated, with 5 mg and placebo having comparable rates of adverse events (AEs) and serious adverse events (SAEs). For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Champions Oncology, Inc. (NASDAQ: CSBR) for due-diligence and potential coverage as the Company announced on July 27, 2017, its financial results for Q4 FY17 and year which ended on April 30, 2017. Tune in to our site to register for a free membership, and be among the early birds that get our report on Champions Oncology when we publish it.
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A previous Phase-2 trial of Velusetrag showed that all three doses of Velusetrag (5, 15, and 30 mg) reduced gastric emptying time (GE t1/2) compared to placebo in patients with either diabetic or idiopathic gastroparesis.
Findings of the Study
- The study was conducted in 232 patients with either diabetic or idiopathic gastroparesis who received either Velusetrag (5, 15 or 30 mg) or placebo, administered orally as a once daily dose, for four weeks. Primary assessments showed that patients in the 5 mg Velusetrag treatment arm demonstrated statistically significant improvements in symptom scores compared to placebo in two separate patient reported outcome (PRO) tools: the Gastroparesis Cardinal Symptom Index (GCSI) (nominal p=0.0327) and the Gastroparesis Rating Scale (GRS) (nominal p = 0.0159).
- Patients in the 5 mg treatment arm also demonstrated statistically significant improvements in gastric emptying time (nominal p < 0.001), compared to placebo, and also in individual disease-specific symptom scores with 5 mg of Velusetrag, observed in both diabetic and idiopathic gastroparesis patients.
- Patients in the 15 mg and 30 mg Velusetrag study arms did not demonstrate nominally statistically significant improvements in gastroparesis symptoms versus placebo, possibly due to an increased frequency in gastrointestinal side effects at these doses that may have been caused by rapid emptying of the stomach.
- Rates of AEs and SAEs are observed to be comparablebetween the 5 mg dose and placebo. The most commonly reported AEs were diarrhea, nausea, and headache. Consistent with Velusetrag's mechanism of action, patients receiving treatment demonstrated higher rates of diarrhea and nausea/vomiting than those receiving placebo, and these rates were highest in 15 mg and 30 mg arms of the study. No deaths were reported in the study.
The data will be submitted for presentation at upcoming medical conferences and for publication in appropriate scientific journals.
Results Provide Evidence of Potential Benefits of Velusetrag
Commenting on the study results, Brett Haumann, MD, Chief Medical Officer of Theravance Biopharma, stated:
"We are very encouraged by the results of this study as they demonstrate not only consistent evidence of improved gastric emptying but also meaningful improvement in gastroparesis symptoms following treatment with 5 mg of Velusetrag. The findings from this study demonstrate that a 5 mg dose was sufficient to ameliorate the symptoms of gastroparesis. We believe that these findings provide clear evidence of the potential benefit of Velusetrag in patients with gastroparesis, a debilitating disease in significant need of therapeutic innovation. We are now preparing to meet with regulators to discuss the next phase in our development plan."
About the Phase-2b Study
The study was a multicenter, double-blind, placebo-controlled, parallel group Phase-2b characterizing the impact on symptoms and gastric emptying of multiple doses of Velusetrag administered once daily over 12 weeks of therapy. The study enrolled 232 subjects with diabetic or idiopathic gastroparesis with documented gastric delay, by either gastric emptying scintigraphy (GES) or gastric emptying breath test (GEBT), and documented symptoms prior to and throughout the baseline period.
About Gastroparesis
Gastroparesis is a condition that affects the normal spontaneous movement of the muscles in the stomach. Gastroparesis, the cause of which is usually unknown, can interfere with normal digestion, causing nausea and vomiting, and causing problems with blood sugar levels and nutrition. Severe cases may also suffer from dehydration, electrolyte disturbances, weight loss, and malnutrition. In the United States, around 1.8% of the total population is known to be affected by this disease.
About Velusetrag
Velusetrag is an oral, once-daily investigational medicine discovered internally and developed for gastrointestinal motility disorders, including gastroparesis, chronic idiopathic constipation, and irritable bowel syndrome. The compound has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis. Velusetrag is being developed by Theravance Biopharma in collaboration with Alfasigma (S.p.A.).
Last Close Stock Review
At the closing bell, on Thursday, August 03, 2017, Theravance Biopharma's stock dropped 6.33%, ending the trading session at $30.02. A total volume of 489.15 thousand shares have exchanged hands, which was higher than the 3-month average volume of 234.84 thousand shares. The Company's stock price surged 21.93% in the previous twelve months. The stock currently has a market cap of $1.63 billion.
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