Part of proteo, inc.
Clinical Trials
1
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2000
Active, not recruiting
1
100.0%
No approval data available
- The global pulmonary arterial hypertension pipeline comprises over 55 companies developing 55+ therapeutic candidates across all clinical phases, representing significant industry investment in this rare disease. - Merck's WINREVAIR (sotatercept-csrk) demonstrated a 76% reduction in relative risk of major morbidity and mortality events in high-risk PAH patients during Phase 3 ZENITH trial results. - Recent regulatory milestones include FDA Fast Track designation for Cereno Scientific's CS1 and IND clearance for VASTHERA's VTB-10, highlighting accelerated development pathways for novel PAH therapies. - AllRock Bio secured $50 million in Series A funding to advance ROC-101, a first-in-class pan-ROCK inhibitor, into Phase 2 trials for PAH and pulmonary hypertension associated with interstitial lung disease.
- tiakis Biotech has completed a comprehensive data package to advance Tiprelestat into Phase II clinical trials for pulmonary arterial hypertension (PAH), following successful completion of a 6-month GLP-tox study. - The preclinical safety study in rats demonstrated no adverse effects at any dose level, establishing a 20-fold safety window for the targeted human dose and supporting fixed doses of 5 mg/day and 10 mg/day subcutaneous administration. - Stanford University is expected to initiate the Phase II ATHENA trial in mid-2026, supported by a double-digit million dollar NIH grant and pending final FDA review. - Tiprelestat represents a first-in-class neutrophil elastase inhibitor and BMPR2 amplifier designed as a disease-modifying therapy for PAH, a rare disease with only 57% five-year survival rate.
- Stanford University has been awarded a double-digit million dollar NIH grant to conduct a Phase II trial of Tiprelestat for pulmonary arterial hypertension, with patient enrollment expected to begin in mid-2026. - Tiprelestat represents a potential disease-modifying therapy that targets underlying inflammation and vascular remodeling in PAH, addressing a critical unmet medical need in a disease with only 57% five-year survival rates. - The investigational drug has demonstrated excellent safety profiles across five clinical trials involving over 100 subjects and has received orphan designation in both the U.S. and Europe. - The FDA has already issued positive scientific advice on the planned trial design, validating the therapeutic approach for this debilitating rare disease.
- 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, 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.
