Date: 2017-07-05
Type of
information: Submission of a clinical trial application
phase: 2a
Announcement: submission of a clinical trial application
Company: Pieris (Germany)
Product: PRS-080
Action
mechanism:
- protein. Anticalins® are engineered human proteins that are able to bind specific target molecules. PRS-080 is a fully proprietary Anticalin program that sequesters hepcidin, typically regarded as the master negative regulator of iron metabolism. With a pharmacokinetic profile tuned to remove hepcidin in line with target turnover dynamics, PRS-080 is intended to optimally mobilize iron trapped in iron storage cells, particularly in anemic patients characterized with functional iron deficiency. Funded by the EC FP7 health program grant GA-No. 278408, this program is supported by the EUROCALIN consortium, led by Pieris.
Disease: Functional Iron Deficiency anemia
Therapeutic
area: Hematological diseases - Metabolic diseases
Country: Czech Republic, Germany
Trial
details:
Latest
news:
- • On July 5, 2017, Pieris announced that the company filed separate clinical trial applications with the German and Czech Republic regulatory authorities to conduct a multi-dose trial for PRS-080 in Functional Iron Deficiency anemia patients in a randomized placebo-controlled trial and, pending timely regulatory approvals, expects to enroll patients in the third quarter across several sites.
- The trial expects to enroll approximately twelve patients, six of whom will receive placebo and six of whom will receive PRS-080, who will be scheduled to receive five weekly doses at 8 mg/kg. Primary endpoints for this study include safety and tolerability of PRS-080, while hemoglobin represents a key secondary endpoint.
Is
general: Yes
