Navidea Biopharmaceuticals Inc (NYSEAMERICAN:NAVB) has posted better results from NAV3-31 Phase 2B trial in patients, who are suffering from RA (Rheumatoid Arthritis). Interim analysis data strengthens Navidea’s notion that TTI (Tc99m tilmanocept) imaging shall provide quantitative and robust imaging in patients suffering from RA. This imaging helps the company measure the effectiveness in patients experiencing RA.
Three arms of NAV3-31 phase 2B trial
Navidea conducts a phase 2B study of NAV3-31 comprising three arms. In arm1, Navidea conducts the trial on healthy subjects. The company conducts an arm2 study on patients suffering from moderate or severe and active RA. In arm3, Navidea conducts a pilot study for the forthcoming phase 3 study, which will assess TTI’s ability to indicate the effectiveness of TNF alpha treatment in patients with RA.
The company has designed a second pro-tem study to verify the data from Arm3 of the phase 2B trial and examine the volume of change of TTI in patients suffering from joint pain caused due to RA. It measures the data before as well as after the treatment using anti-tumor necrosis factor-alpha therapy.
15 subjects participated in an interim study
Navidea has included 15 patients suffering from moderate or severe RA in the interim analysis. Each subject will undergo the treatment using anti-TNF alpha therapy for the first time. The company has obtained hand/ wrist and whole-body gamma images before initiating the first treatment and after 5-weeks of the treatment. It will also obtain gamma images from patients after 12 weeks on eight of the fifteen patients. The company has obtained a baseline and five-week scans on balance 7 subjects at the time of analysis.
Chief Medical Officer of Navidea, Michael Rosel, said the company is pleased with the interim analysis results, which support continuing the ongoing phase 2B study. The company is on track to provide a quantifiable and non-invasive treatment to patients with RA.
Highlights in Q1 2020
Navidea signed an LOI with Worldcare LLC for its RA diagnostic clinical imaging. The company also regained distribution and commercialization for Tc99m tilmanocept injection in Europe. On receipt of FDA nod for RA diagnostic, WorldCare would act as its central imaging provider.