Nuance Pharma has announced that the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine in patients with COPD has met its primary endpoint. The company obtained the rights to ensifentrine, a PDE3/PDE4 inhibitor, in China, Macau, Taiwan, and Hong Kong from Verona Pharma in 2021 and announced the initiation of the ENHANCE-CHINA trial in April 2023. Nuance says … [Read more...] about Nuance says Phase 3 ENHANCE-CHINA trial of nebulized ensifentrine met its primary endpoint
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Rein Therapeutics initiates Phase 2 trial of its LTI-03 caveolin-1-related peptide DPI in IPF patients
Rein Therapeutics (formerly Aileron Therapeutics) has announced the initiation of the Phase 2 RENEW trial of LTI-03, an inhaled dry powder caveolin-1 scaffolding domain peptide. The company had announced plans for the study in January 2025 and recently said that it had received two new patents covering LTI-03. The trial is expected to enroll up to 120 patients … [Read more...] about Rein Therapeutics initiates Phase 2 trial of its LTI-03 caveolin-1-related peptide DPI in IPF patients
LTR Pharma announces agreement with SDS for development of nasal spray for difficulty in swallowing
LTR Pharma announced a development agreement with Strategic Drug Solutions, Inc. for development of a nasal spray for the treatment of esophageal motility disorders (difficulty in swallowing). The Australian company says that the product will be called Oroflow but did not provide any additional information. LTR is currently developing Spontan intranasal vardenafil for … [Read more...] about LTR Pharma announces agreement with SDS for development of nasal spray for difficulty in swallowing
Ethris gets €10 million EU4Health grant for studies of ETH47 inhaled/nasal antiviral
Vaccine developer Ethris, which recently received $5 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) for development of spray-dried RNA vaccines for nasal delivery, has announced that EU4Health has awarded the company a €10 million grant to support research on ETH47, an mRNA-based antiviral designed specifically for respiratory … [Read more...] about Ethris gets €10 million EU4Health grant for studies of ETH47 inhaled/nasal antiviral
AstraZeneca says two Phase 3 trials of Breztri Aerosphere MDI in uncontrolled asthma met their primary endpoints
According to AstraZeneca, the Phase 3 KALOS and LOGOS trials comparing Breztri (Trixeo) Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI to inhaled ICS/LABA in patients with uncontrolled asthma both met their primary endpoints. Breztri has been approved in the US for the treatment of COPD since July 2020 and is currently approved that indication in … [Read more...] about AstraZeneca says two Phase 3 trials of Breztri Aerosphere MDI in uncontrolled asthma met their primary endpoints
Orexo announces data from study of intranasal dry powder flu vaccine in rats
According to Orexo, a dry powder formulation of an intranasal influenza vaccine formulated with the company's AmorphOX powder engineering platform has produced a similar immune response in rats compared to a liquid formulation of the same vaccine. The company said that the proof of concept study demonstrated strong mucosal immune response in the nose and in the lung … [Read more...] about Orexo announces data from study of intranasal dry powder flu vaccine in rats
University of Maryland researchers to conduct Phase 2 trial of ENA Respiratory’s INNA-051 dry powder nasal TLR2/6 agonist
ENA Respiratory has announced that researchers at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health will conduct a Phase 2 study of ENA's INNA-051 intranasal dry powder TLR2/6 agonist, which the company is developing for the treatment of viral respiratory infections. Earlier this year, the company announced that it had … [Read more...] about University of Maryland researchers to conduct Phase 2 trial of ENA Respiratory’s INNA-051 dry powder nasal TLR2/6 agonist
Lonza to develop spray dried formulations of Ethris’s nasal mRNA-based vaccines
Inhaled vaccine developer Ethris and CDMO Lonza have announced that Lonza will develop spray-dried formulations of Ethris mRNA-based vaccine candidates. Earlier this year, Ethris announced that it would receive $5 million from the Coalition for Epidemic Preparedness Innovations (CEPI) for development of spray-dried RNA vaccines for nasal delivery. The companies said … [Read more...] about Lonza to develop spray dried formulations of Ethris’s nasal mRNA-based vaccines
Avalyn announces plans to advance AP02 inhaled nintedanib into Phase 2 trial in IPF patients
According to Avalyn Pharma, Phase 1 trials of AP02 inhaled nintedanib demonstrated that all dose levels of the nebulized formulation were safe and well tolerated and that the company now plans to advance AP02 into a Phase 2 trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn said that it will present top-line data from the Phase 1 studies at the … [Read more...] about Avalyn announces plans to advance AP02 inhaled nintedanib into Phase 2 trial in IPF patients
Lovaltech gets go-ahead for MUCOBOOST Phase 1 trial of LVT-001 intranasal vaccine against COVID-19
French biotech Lovaltech announced that the Agence nationale de sécurité du médicament (ANSM) and the Comité de Protection des Personnes (CPP) have authorized the company's planned MUCOBOOST Phase 1 trial of LVT-001 nasal vaccine against COVID-19, and the trial is expected to start by the end of April 2025. The study, which is expected to enroll 36 adults aged 18-55, … [Read more...] about Lovaltech gets go-ahead for MUCOBOOST Phase 1 trial of LVT-001 intranasal vaccine against COVID-19