Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis

Merck/MSD announced today that the Phase 3 HYPERION trial on pulmonary arterial hypertension patients (Group 1 World Health Organisation) in functional class II-III was suspended. Patients in the study will be offered the option of receiving WINREVAIR through the Phase 3 SOTERIA open-label extension study. Findings from the HYPERION study will be available later this […]

Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis Read Post »

Alivegen’s ALG-801 given orphan drug designation for the treatment of pulmonary arterial hypertension, Pulmonary Hypertension News, January 8, 2025

ALG-801 is a next-generation ligand trap targeting type IIA/IIB activin receptors that selectively sequesters a specific set of molecules that activate the Smad2/3 pathway, known to be involved in pulmonary arterial hypertension. Smad2/3 is implicated in the growth of pulmonary artery smooth muscle cells, which contributes to blood vessel remodeling, essentially structural alterations, and narrowing

Alivegen’s ALG-801 given orphan drug designation for the treatment of pulmonary arterial hypertension, Pulmonary Hypertension News, January 8, 2025 Read Post »

The Dutch Pulmonary Hypertension Association has contributed financially to the RECOMPENSE Phase 4 study on sotatercept conducted by the Amsterdam University Medical Center

The Dutch Pulmonary Hypertension Association, Stichting Pulmonale Hypertensie, has contributed financially with an amount of € 40.000 the RECOMPENSE – Right VEntricular COMPENsation with SotatercEpt – Phase 4 study conducted by the Amsterdam UMC. This research aims to investigate sotatercept’s effects on right ventricular function. Background Several large international studies have already been conducted in

The Dutch Pulmonary Hypertension Association has contributed financially to the RECOMPENSE Phase 4 study on sotatercept conducted by the Amsterdam University Medical Center Read Post »

Simulation of clinical trials of oral treprostinil in pulmonary arterial hypertension using a virtual population, Nature Briefing Journal, January 15, 2025

The study published recently in the Nature Briefing Journal explores using mathematical modeling to address drug development challenges in pulmonary arterial hypertension. Researchers developed a quantitative systems pharmacology (QSP) model in the context of oral treprostinil clinical studies to predict changes in pulmonary vascular resistance and six-minute walk distance by creating a virtual patient population

Simulation of clinical trials of oral treprostinil in pulmonary arterial hypertension using a virtual population, Nature Briefing Journal, January 15, 2025 Read Post »

Positive scientific advice from the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of tiprelestat in pulmonary arterial hypertension

Tiakis Biotech has received positive scientific advice from the US Food and Drug Administration (FDA) for a planned Phase 2 ATHENA clinical trial of tiprelestat in pulmonary arterial hypertension. The therapy has been granted orphan designation in the U.S. and in Europe for pulmonary arterial hypertension. Dr. Roham Zamanian, Professor of Medicine at Stanford University and

Positive scientific advice from the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of tiprelestat in pulmonary arterial hypertension Read Post »

Proud to celebrate the 14 live webinars we have organised since the series launched in June 2023! A huge thank you to all our speakers and participants!

The Alliance for Pulmonary Hypertension (AfPH) recently concluded its 14th webinar, marking the culmination of an educational initiative that began in June 2023. These virtual gatherings brought together internationally renowned experts in pulmonary hypertension, who shared their expertise on a comprehensive range of topics crucial to advancing patient care and quality of life. The diverse

Proud to celebrate the 14 live webinars we have organised since the series launched in June 2023! A huge thank you to all our speakers and participants! Read Post »

New research published in “The Lancet” suggests that the seratonin pathway might not be a suitable option for pulmonary arterial hypertension therapy, September 19, 2024

New research published in The Lancet on September 19, 2024, suggests that the seratonin pathway might not be a suitable option for pulmonary arterial hypertension therapy. The role of serotonin in pulmonary arterial hypertension has been extensively studied in recent decades, with preclinical data indicating involvement in disease pathogenesis; however, clinical studies up to now

New research published in “The Lancet” suggests that the seratonin pathway might not be a suitable option for pulmonary arterial hypertension therapy, September 19, 2024 Read Post »

New research suggests that the serotonin pathway might not be a suitable option for pulmonary arterial hypertension therapy, The Lancet Respiratory Medicine, September 19, 2024

The role of serotonin in pulmonary arterial hypertension has been extensively studied in recent decades, with preclinical data indicating involvement in disease pathogenesis; however, clinical studies have yielded mixed results. New research published in The Lancet suggests that the seratonin pathway might not be a suitable option for pulmonary arterial hypertension therapy. ELEVATE-2 was a

New research suggests that the serotonin pathway might not be a suitable option for pulmonary arterial hypertension therapy, The Lancet Respiratory Medicine, September 19, 2024 Read Post »

New study finds that elevated “asporin” levels in pulmonary arterial hypertension lung samples are linked to lower disease severity, Healio news, October 2, 2024

In pulmonary arterial hypertension lung samples researchers have observed elevated asporin levels and found a link between these levels and lower disease severity. Higher levels of asporin appeared to counteract the pathological remodeling of the pulmonary vasculature that characterizes pulmonary arterial hypertension. Jason Hong, MD, PhD, assistant clinical professor at David Geffen School of Medicine

New study finds that elevated “asporin” levels in pulmonary arterial hypertension lung samples are linked to lower disease severity, Healio news, October 2, 2024 Read Post »

Results of the INSIGNIA-PAH study on MK-5475, an inhaled soluble guanylate cyclase stimulator for pulmonary arterial hypertension, published on the ERS Respiratory Journal, Vol 64 Issue 3, 2024

MK-5475 is an experimental soluble guanylate cyclase stimulator which is administered via dry powder inhalation and is designed to potentially mitigate the side effects associated with systemic vasodilation. The results of the INSIGNIA-PAH study published in the Respiratory Journal suggest that MK-5475 reduced pulmonary vascular resistance (PVR) and was well tolerated in patients with pulmonary

Results of the INSIGNIA-PAH study on MK-5475, an inhaled soluble guanylate cyclase stimulator for pulmonary arterial hypertension, published on the ERS Respiratory Journal, Vol 64 Issue 3, 2024 Read Post »

Cereno Scientific announces positive topline results of Phase IIa trial with lead candidate CS1 in pulmonary arterial hypertension, September 27, 2024

CS1 is a HDAC, Histone Deacetylase inhibitor, that works through epigenetic modulation and is being developed by Cereno Scientific as a disease modifying treatment for pulmonary arterial hypertension. CS1 targets the root cause of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries. The Phase IIa trial evaluated the safety,

Cereno Scientific announces positive topline results of Phase IIa trial with lead candidate CS1 in pulmonary arterial hypertension, September 27, 2024 Read Post »

“Serotonin pathway blockade in pulmonary arterial hypertension”, The Lancet Respiratory Medicine, September 19, 2024

Article exploring the serotonin pathway in pulmonary arterial hypertension care published in The Lancet Respiratory Medicine on September 19, 2024, titled “Serotonin pathway blockade in pulmonary arterial hypertension”. The author is Marcin Kurzyna, MD, PhD, FESC Citation Serotonin pathway blockade in pulmonary arterial hypertension, Kurzyna, Marcin, The Lancet Respiratory Medicine, Volume 0, Issue 0, DOI: 10.1016/S2213-2600(24)00291-1

“Serotonin pathway blockade in pulmonary arterial hypertension”, The Lancet Respiratory Medicine, September 19, 2024 Read Post »

Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus, “Respiratory Medicine”

Oral treprostinil is a prostacyclin analogue approved to treat pulmonary arterial hypertension (PAH). A study analysing the practical management of oral treprostinil in patients with pulmonary arterial hypertension has been published on “Respiratory Medicine” Volume 231, 107734, September 2024. The article is based on results of the ADAPT and EXPEDITE trials and expert consensus. The

Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus, “Respiratory Medicine” Read Post »

Aerovate Therapeutics announces that its pulmonary arterial hypertension candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial

Aerovate Therapeutics has announced that its pulmonary arterial hypertension (PAH) candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial. The Phase IIb portion of the IMPAHCT trial aimed to assess three different doses of AV-101, a novel dry powder inhaled formulation of imatinib. The primary endpoint tested

Aerovate Therapeutics announces that its pulmonary arterial hypertension candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial Read Post »

Gossamer Bio and Chiesi Group announce global collaboration to develop and commercialise seralutinib in pulmonary arterial hypertension (PAH) and pulmonary hypertension with interstitial lung disease (PH-ILD)

Gossamer Bio and Chiesi Group have announced a a global collaboration agreement to develop seralutinib, an inhaled investigational drug for the treatment of pulmonary arterial hypertension. Seralutinib is currently being investigated in the ongoing global Phase 3 trial, PROSERA, for pulmonary arterial hypertension. This collaboration further enhances the resources and expertise devoted to seralutinib and

Gossamer Bio and Chiesi Group announce global collaboration to develop and commercialise seralutinib in pulmonary arterial hypertension (PAH) and pulmonary hypertension with interstitial lung disease (PH-ILD) Read Post »

United Therapeutics has been granted a patent for a method to treat pulmonary arterial hypertension (PAH) by administering endothelial progenitor cells treated with prostacyclin

United Therapeutics has been granted a patent for a method to treat pulmonary arterial hypertension (PAH) by administering endothelial progenitor cells treated with prostacyclin Application n° US17072430, December 12, 2023, Publication Number: US11839631B2. The news was reported in the Magazine “Pharmaceutical Technology, April 4, 2024. To be followed! Read more at this link on the

United Therapeutics has been granted a patent for a method to treat pulmonary arterial hypertension (PAH) by administering endothelial progenitor cells treated with prostacyclin Read Post »

The Phase 3 clinical trial to evaluate the safety and efficacy of oral inhalation of seralutinib for pulmonary arterial hypertension is enrolling

The PROSERA Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of the oral Inhalation of seralutinib for the treatment of pulmonary arterial hypertension is currently enrolling. The PROSERA study’s objective is to understand the effect of seralutinib on specific pathways in the body that lead to the inflammation, proliferation and fibrosis

The Phase 3 clinical trial to evaluate the safety and efficacy of oral inhalation of seralutinib for pulmonary arterial hypertension is enrolling Read Post »

Phase 1 clinical trial on a treprostinil skin patch for pulmonary arterial hypertension due to start shortly

Corsair Pharma has developed a proprietary transdermal patch intended to provide consistent blood levels of treprostinil, a drug currently administered via a 24/7 infusion pump (sub-cutaneous or intra-venous, see this link for more details), by delivering an inactive prodrug, which crosses the skin, enters the blood, and converts rapidly to treprostinil in the liver. Since

Phase 1 clinical trial on a treprostinil skin patch for pulmonary arterial hypertension due to start shortly Read Post »

“Discovering New Pulmonary Hypertension Therapies on the Horizon”, a live webinar on February 21, 2024, organised by the US Pulmonary Hypertension Association, PHA

Join the Pulmonary Hypertension Association, PHA, for the upcoming “Discovering New Pulmonary Hypertension Therapies on the Horizon” PHA Live webinar on Wednesday, Feb. 21 at 2 pm. EST/ 7 p.m. UTC. During the webinar, Sandeep Sahay, MD, MSc, ATSF, will review: Don’t miss this opportunity to gain insights into these promising therapies that will help manage your

“Discovering New Pulmonary Hypertension Therapies on the Horizon”, a live webinar on February 21, 2024, organised by the US Pulmonary Hypertension Association, PHA Read Post »

Prof. Adam Torbicki explores access to care, Prof. Jean-Luc Vachiéry delves into drug development – watch the highlights from the PHA Europe Annual Conference online

Prof. Adam Torbicki’s presentation is titled “Access to care for pulmonary arterial hypertension and chronic thromboembolic pulmponary hypertension”. It can be viewed at this link on Vimeo (you need to register on Vimeo to see it) Prof. Jean-Luc Vachiéry’s presentation is titled “Drug development and clinical trials“. It can be viewed at this link on

Prof. Adam Torbicki explores access to care, Prof. Jean-Luc Vachiéry delves into drug development – watch the highlights from the PHA Europe Annual Conference online Read Post »

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