Clinical trials/research – Page 4 – PULMONARY HYPERTENSION

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 »

Wrapping up a successful year of pulmonary hypertension knowledge-sharing educational live web events!

The Alliance for Pulmonary Hypertension has just held the last webinar of the six-part series it launched in June 2023 exploring the innovations outlined in the 2022 joint clinical guidelines on pulmonary hypertension by the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Across these six insightful sessions, we delved into pivotal

Wrapping up a successful year of pulmonary hypertension knowledge-sharing educational live web events! Read Post »

The US Pulmonary hypertension Association, PHA, is partnering with the Fundación Contra la Hipertensión Pulmonar, Spain, to host a two-part Live webinar series, simulcast in English and Spanish

November 30, 2 pm EST The first webinar, “Hope Through Research in Pulmonary Hypertension: Emerging Developments,” will review emerging pulmonary hypertension research developments and the potential impact they’ll have on the PH community. December 14, 2 pm EST The second webinar, “Hope Through Research in Pulmonary Hypertension: Clinical Trials,” will discuss the clinical trial process,

The US Pulmonary hypertension Association, PHA, is partnering with the Fundación Contra la Hipertensión Pulmonar, Spain, to host a two-part Live webinar series, simulcast in English and Spanish Read Post »

J&J subsidiary Janssen has terminated the Phase III MACiTEPH trial of macitentan in chronic thromboembolic pulmonary hypertension (MACiTEPH)

The trial was evaluating efficacy and safety of Macitentan 75 mg in Inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. It was a prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 Study. The decision to drop the study is in line with the recommendation of an independent data monitoring committee, which found during a

J&J subsidiary Janssen has terminated the Phase III MACiTEPH trial of macitentan in chronic thromboembolic pulmonary hypertension (MACiTEPH) Read Post »

KEROS Therapeutics announces launch of a Phase 2 trial, TROPOS, to assess the effectiveness of KER-012 as add-on treatment in pulmonary arterial hypertension

Keros Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application to conduct a Phase 2 clinical trial of KER-012, TROPOS, in combination with background therapy in patients with pulmonary arterial hypertension. KER-012 KER-012 is designed to normalize blood vessel thickness and heart function in pulmonary hypertension.

KEROS Therapeutics announces launch of a Phase 2 trial, TROPOS, to assess the effectiveness of KER-012 as add-on treatment in pulmonary arterial hypertension Read Post »

Update on Merck Phase 2/3 INSIGNIA-PAH clinical trial investigating inhaled treatment MK-5475 in pulmonary arterial hypertension

Merck’s investigational inhaled soluble guanylate cyclase (sGC) stimulator MK-5475 was well-tolerated and showed promise among adults with pulmonary arterial hypertension (PAH) in a Phase 1 clinical trial (see our article on this topic at this link). Merck is sponsoring a Phase 2/3 study. Learn more about the INSIGNIA-PAH trial at this link on the Merck website

Update on Merck Phase 2/3 INSIGNIA-PAH clinical trial investigating inhaled treatment MK-5475 in pulmonary arterial hypertension Read Post »

EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023

The aim of the EVOLVE study is to observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with pulmonary arterial hypertension.

EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023 Read Post »

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023

Aerami Therapeutics has announced new additions to its management team as the company prepares for the imminent initiation of the planned “uniPHied” Phase 2 trial of AER-901 (inhaled imatinib), in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). AER-901 is a drug-device combination delivered via a high-performance, handheld nebulizer that

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023 Read Post »

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023

ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And Function) is a Phase 4, Prospective, Multi-center, Single-Arm Study to assess the effect of early and rapid treprostinil therapy to reduce mean pulmonary artery pressure (mPAP, improve right ventricular (RV) function, and reverse RV remodeling, in patients with pulmonary arterial hypertension (PAH). Estimated enrolment is 50

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023 Read Post »

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023

Zambon, a multinational pharmaceutical company, announced today that it has completed enrollment in its two pivotal Phase 3 studies. The trials are designed to evaluate the safety and efficacy of Liposomal Cyclosporine A for Inhalation (L-CsA-i) for the treatment of BOS in adults following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation. BOS is a

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023 Read Post »