Pulmonology

Chronic obstructive pulmonary disease, a condition CDC estimates affects about 14.2 million (6.5%) U.S. adults, can be brutal. And for patients with COPD, exacerbations are an acute risk, a sudden flare-up where breathing becomes a potentially life-threatening struggle against inflamed airways. “Anecdotally… if I reflect back on some of my experiences in… emergency medicine departments…

Earlier this year, at the JP Morgan Healthcare conference, Regeneron CEO Leonard Schleifer referred to Dupixent (dupilumab), the fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, as “a pipeline in a single product.”  The drug, co-developed by Sanofi and Regeneron, is following a similar course to AbbVie’s…

On the heels of announcing positive data for Dupixent (dupilumab) in atopic dermatitis patients with darker skin tones, Sanofi and Regeneron have announced that the monoclonal antibody outperformed Xolair (omalizumab) in the phase 4 EVEREST trial. Marking the first head-to-head comparison of biologic respiratory medicines, the study focused on patients with severe chronic rhinosinusitis with…

An AI-designed drug, rentosertib, from Insilico Medicine improved lung function by 98.4 mL in a 71-patient idiopathic pulmonary fibrosis study published June 3 in Nature Medicine, marking what may be the first peer-reviewed phase 2a result for a molecule generated, with its target discovered, entirely by generative AI. In an email, Insilico CEO Alex Zhavoronkov,…

The FDA on May 22 cleared GSK’s interleukin-5 antibody Nucala (mepolizumab) as an add-on to inhaled triple therapy for adults whose chronic obstructive pulmonary disease keeps flaring despite treatment and whose blood-eosinophil count starts at 150 cells/µL. The approval is on the basis of the MATINEE and METREX phase 3 trials. The MATINEE study, which…

Idiopathic Pulmonary Fibrosis (IPF), a devastating lung disease affecting millions with increasing incidence, may have a new treatment hope thanks to a novel inhibitor of TNIK, a kinase newly implicated in fibrosis, identified using generative AI drug discovery platforms in just 18 months. Researchers at Insilico Medicine, along with international collaborators, harnessed the power of…

Pulmonary arterial hypertension (PAH) is a relatively rare disorder, affecting roughly 15 to 50 people per million within the U.S. and Europe. Treating it with a single therapy can be challenging, and medication adherence often presents a common hurdle for the condition. Combination therapy has thus become a widely used option in the treatment of…

Insilico Medicine, an AI-based biotech startup, announced details of their first AI-designed drug candidate to enter human clinical trials. INS018_055 is an experimental treatment for idiopathic pulmonary fibrosis, a rare lung disease. Through their Insilico AI-driven drug discovery platform, they discovered and designed INS018_055 in just 30 months, significantly faster than the industry average. Phase…

Roughly a year ago, Insilico Medicine announced that it had dosed the first patient in a phase 1 study of INS018_055, an AI-discovered, first-in-class small molecule inhibitor. Now, the company has progressed to the next stage, launching a phase 2 study for the drug candidate. Insilico, a founding member of NVIDIA Inception, developed its AI…

FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 in favor of the albuterol/budesonide (PT027) from AstraZeneca (Nasdaq:AZN) to treat asthma in people at least 18 years old. The voting proposition asked whether the data supported a favorable benefit-risk assessment for various age groups. The advisory committee did not endorse albuterol/budesonide for patients 12…

Currently, there are only two FDA-approved drugs for idiopathic pulmonary fibrosis (IPF) — Ofev (nintedanib) from Boehringer Ingelheim and Esbriet (pirfenidone) from Genentech. Now, Boehringer Ingelheim is announcing the launch of the global FIBRONEER-IPF study focused on BI 1015550, an experimental phosphodiesterase 4B (PDE4B) inhibitor, in idiopathic pulmonary fibrosis (IPF). The study is part of…

The Pulmonary Fibrosis Foundation (PFF) has launched the PFF Community Registry to facilitate research on pulmonary fibrosis (PF) and interstitial lung disease (ILD). The PFF Community Registry collects self-reported data from patients, nonprofessional caregivers and biological family members via a secure online portal. Participation is voluntary. “There’s a research opportunity to see if there are any differences…

Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies recently announced analysis data on the benefits of Xarelto. The Phase 3 Voyager PAD clinical trial evaluated the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER).…

Inhalable insulin specialist MannKind Corp. (NASDAQ:MNKD) announced that the FDA is extending its deadline to review United Therapeutics’ (NASDAQ:UTHR) new drug application (NDA) for Tyvaso DPI from February to May. MannKind is developing Tyvaso DPI (treprostinil) in collaboration with United Therapeutics. The drug candidate Tyvaso DPI would potentially treat pulmonary arterial hypertension and pulmonary hypertension…

The drug development landscape in idiopathic pulmonary fibrosis is changing rapidly. “There are probably 30 or 40 different compounds in development,” said Dr. Toby Maher, a presenter at the Pulmonary Fibrosis Foundation (PFF) Summit held last month. Of those, a handful have reached Phase 2 and Phase 3 clinical trials. Here, we highlight a handful…

The biopharma TFF Pharmaceuticals (NSDQ:TFFP) has announced that its inhalation powder of the immunosuppressive drug tacrolimus was well tolerated in a Phase 1 trial in lung transplant patients. Tacrolimus is a traditional option for preventing rejection of a transplanted organ, albeit in tablet or capsule form. It is common for lung transplant recipients to have…

Small molecule drug developer Aria Pharmaceuticals (Palo Alto, Calif.) recently revealed that two investigational treatments for idiopathic pulmonary fibrosis (IPF), TXR-1002 and TXR-1007, demonstrated promising results in preclinical research. There are currently only two FDA-approved treatments for IPF on the market — nintedanib (Ofev) from Boehringer Ingelheim and pirfenidone (Esbriet) from Roche. While those introductions…

This September is Pulmonary Fibrosis Awareness Month, which the Pulmonary Fibrosis Foundation (PFF) and allies have launched to educate the public about the disease family. Involving scarring of the lungs, pulmonary fibrosis gradually robs the breath from patients it affects.  Some 250,000 Americans live with idiopathic pulmonary fibrosis, according to PFF.   At present, two drugs…

A few decades ago, an HIV diagnosis was akin to a death sentence. But with proper treatment including antiretroviral therapy, HIV patients can often expect to have a normal life expectancy. David Jimenez, former president of Johnson & Johnson’s Janssen Infectious Diseases, is confident that similar breakthroughs can happen in pulmonary hypertension. “We’re not there…