Avalyn Pharma has published data from its Phase 1b ATLAS study evaluating the safety of AP01 nebulized pirfenidone in patients with idiopathic pulmonary fibrosis over 72 weeks. In the article, the authors report that treatment-related adverse events were mild-to-moderate and less frequent than side effects associated with oral pirfenidone. They also reported that … [Read more...] about Avalyn reports data from Phase 1b study of AP01 inhaled pirfenidone in IPF patients
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Vistagen announces results from Phase 3 safety trial of fasedienol (PH94B) nasal spray for social anxiety
Vistagen said that a Phase 3 open label safety study of fasedienol (PH94B, aloradine) nasal spray for the treatment of social anxiety disorder (SAD) found that up to 4 daily doses of 3.2 µg was well-tolerated, with no new safety findings. The company said that on the secondary endpoint of change from baseline on the Liebowitz Social Anxiety Scale (LSAS), "Analysis of … [Read more...] about Vistagen announces results from Phase 3 safety trial of fasedienol (PH94B) nasal spray for social anxiety
Firebrick Pharma restarts Phase 3 trial of Nasodine nasal spray for the common cold
Firebrick Pharma announced that it is re-starting a Phase 3 clinical trial of Nasodine povidone-iodine nasal spray as the 2023 common cold season begins in the Southern Hemisphere. According to the company, the trial, which is taking place in Australia and South Africa, was paused for the summer after having fulfilled half of its recruitment goal during the 2022 cold … [Read more...] about Firebrick Pharma restarts Phase 3 trial of Nasodine nasal spray for the common cold
Phase 2a study of Aridis’s AR-501 inhaled gallium in CF patients meets primary and secondary endpoints
Aridis Pharmaceuticals has announced that a Phase 2a study of the company's AR-501 nebulized gallium in cystic fibrosis patients with P. aeruginosa lung infections met its primary and secondary endpoints, with all 3 dose levels tested being well tolerated. According to Aridis, uptake of AR-501 in the respiratory track was up to 10 times higher than previously reported … [Read more...] about Phase 2a study of Aridis’s AR-501 inhaled gallium in CF patients meets primary and secondary endpoints
ReCode initiates Phase 1 trial of RCT1100 inhaled mRNA therapeutic
ReCode Therapeutics said that it has initiated a Phase 1 clinical trial of its RCT1100 nebulized mRNA-based therapeutic, which the company is developing for the treatment of primary ciliary dyskinesia (PCD) caused by certain genetic mutations. ReCode had announced positive preclinical results for RCT1100 for the treatment of PCD in August 2021. The Phase 1 single … [Read more...] about ReCode initiates Phase 1 trial of RCT1100 inhaled mRNA therapeutic
Iliad publishes data from Phase 2b challenge study of BPZE1 intranasal pertussis vaccine
Iliad Biotechnologies announced that it has published data from a Phase 2b challenge study of its BPZE1 live-attenuated intranasal pertussis vaccine and said that the vaccine induced nasal mucosal and serum immune responses, with 90% of participants who received a single dose of BPZE1 protected from colonization following a challenge with attenuated B. pertussis at 3 … [Read more...] about Iliad publishes data from Phase 2b challenge study of BPZE1 intranasal pertussis vaccine
NeOnc Technologies announces plans to develop NEO100 intranasal perillyl alcohol for pediatric brain tumors
NeOnc Technologies has announced plans to develop its NEO100 intranasal perillyl alcohol for the treatment of high-grade gliomas in children. In 2016, NeOnc initiated a Phase 1/2a trial of NEO100 in adults with glioblastoma multiforme; according to clinicaltrials.gov, that study is expected to be completed in 2024. In 2020,the company published Phase 1 data for 12 … [Read more...] about NeOnc Technologies announces plans to develop NEO100 intranasal perillyl alcohol for pediatric brain tumors
Armata reports results from Phase 1b/2a trial of AP-PA02 inhaled phage therapy, announces initiation of Phase 2 trial of AP-PA02 for NCFB
Armata Pharmaceuticals announced that data from the Phase 1b/2a SWARM-P.a. SAD/MAD study of its AP-PA02 nebulized phage therapy in cystic fibrosis patients with chronic P. aeruginosa lung infections "confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure." The company had announced the completion of the … [Read more...] about Armata reports results from Phase 1b/2a trial of AP-PA02 inhaled phage therapy, announces initiation of Phase 2 trial of AP-PA02 for NCFB
Bryn Pharma says study demonstrated that its Utuly intranasal epinephrine “provides an enhanced PK profile” compared to autoinjector
Bryn Pharma has presented data from a bioavailability study of its Utuly epinephrine nasal spray demonstrating that 13.2 mg dose of Utuly absorbed as fast and produced higher and longer-lasting epinephrine plasma levels than a 0.3 mg autoinjector. Compared to a 0.5 mg dose of epinephrine delivered via manual syringe, Utuly absorbed faster and reached comparable or … [Read more...] about Bryn Pharma says study demonstrated that its Utuly intranasal epinephrine “provides an enhanced PK profile” compared to autoinjector
Aerami expands development of AER-901 inhaled imatinib to include PH-ILD
Aerami Therapeutics announced that it will develop its AER-901 nebulized imatinib for pulmonary hypertension associated with interstitial lung disease (PH-ILD) in addition to pulmonary arterial hypertension (PAH). The FDA granted orphan drug designation to AER-901 for the PAH indication in August 2021, and the company says that it recently completed a Phase 1 trial of … [Read more...] about Aerami expands development of AER-901 inhaled imatinib to include PH-ILD