Date: 2015-12-14
Type of information: Results
phase: 1-2
Announcement: results
Company: Atara Biotherapeutics (USA - CA)
Product: PINTA 745
Action
mechanism: peptibody. PINTA 745 is a peptibody that binds myostatin and inhibits its corresponding signal transduction, thereby blocking the negative regulation of skeletal muscle growth. Through its biologic activity in blocking myostatin activity and in mitigating inflammatory mediators, PINTA 745 may have the potential to decrease the manifestations of protein-energy wasting, reduce the rates of serious complications, and improve functional status.
Disease: protein energy wasting in patients with end stage renal disease
Therapeutic area: Kidney diseases - Renal diseases
Country: USA
Trial
details: This pilot study has been designed to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting in patients receiving maintenance hemodialysis . (NCT01958970)
Latest
news: * On December 14, 2015, Atara Biotherapeutics announced results from its Phase 2 proof-of-concept clinical trial for PINTA 745 for the treatment of protein energy wasting in patients with end stage renal disease. The trial did not meet its primary endpoint, defined as the percent change from baseline in Lean Body Mass (LBM) as measured by Dual Energy X-Ray Absorptiometry (DXA) at week 12 following weekly treatment with PINTA 745.
PINTA 745 also did not improve physical function, measures of glycemic control and markers of inflammation. There were no treatment related serious adverse events observed in the trial. As a consequence of these results, Atara Bio will suspend further development of PINTA 745. To date, third-party direct costs for the development of PINTA 745 from our inception through the third quarter of 2015 were approximately $10 million.
