tiakis BIOTECH AG

tiakis Biotech's Tiprelestat Receives FDA Support for Phase II PAH Trial

5 months ago

• tiakis Biotech AG received positive scientific advice from the FDA for its planned Phase II trial of Tiprelestat in Pulmonary Arterial Hypertension (PAH). • The ATHENA trial will be a randomized, double-blind study with three cohorts enrolling 90 PAH patients to assess Tiprelestat's safety and efficacy. • The primary endpoint of the ATHENA trial will be Pulmonary Vascular Resistance (PVR), with the secondary endpoint being the 6-Minute Walk Distance (6MWD). • Tiprelestat, a recombinant human Elafin, has shown vascular remodeling capabilities in animal models and addresses inflammation and BMPR2 deficiency in PAH.

Tiprelestat Shows Promise in COVID-19 Patients: tiakis Biotech Announces Phase Ib/II Trial Results

6 months ago

• Tiprelestat, a human recombinant Elafin, demonstrated a favorable safety profile in hospitalized COVID-19 patients, with no significant adverse effects reported during the Phase Ib/II trial. • Exploratory efficacy data suggest a potential reduction in the duration of oxygen support needed for patients treated with Tiprelestat compared to the placebo group. • The study also indicated a possible decrease in the incidence of renal issues among patients receiving Tiprelestat, warranting further investigation in larger clinical trials. • tiakis Biotech AG plans to advance the development of Tiprelestat for other pulmonary diseases, encouraged by the safety and supportive data from the COMCOVID trial.