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Medical

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

BiomX announces data from Phase 1b trial of its BX004 inhaled phage cocktail for the treatment of lung infections in CF patients

Israeli biotech BiomX has announced data from the first part of a Phase 1b/2a trial of the company's BX004 nebulized phage cocktail for the treatment of P. aeruginosa lung infections in cystic fibrosis patients demonstrating a reduction in P. aeruginosa burden. The first portion of the study, which is supported by the Cystic Fibrosis Foundation, enrolled 9 CF patients … [Read more...] about BiomX announces data from Phase 1b trial of its BX004 inhaled phage cocktail for the treatment of lung infections in CF patients

Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray

Firebrick Pharma announced that it has filed a Pediatric Investigation Plan (PIP) with the EMA's Pediatric committee for its Nasodine povidone-iodine nasal spray as the company plans to submit a marketing application for Nasodine by the end of 2023. In April 2022, Firebrick initiated a Phase 2 study of Nasodine for the treatment of COVID-19. A Phase 3 trial of … [Read more...] about Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray

Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT

Beckley Psytech said that the FDA has approved the company's IND for a Phase 2b study comparing 2 doses of BPL–003 intranasal dry powder synthetic 5-MeO-DMT (mebufotenin) in patients with treatment-resistant depression. According to Beckley Psytech, the proposed Phase 2b study, which is expected to be initiated in the first half of this year, is the first ever … [Read more...] about Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT

AAHI gets $3 million for development of antiviral nasal spray

The non-profit Access to Advanced Health Institute (formerly the Infectious Disease Research Institute) said that it has received an award of up to $3 million for development of a prototype antiviral nasal spray from the US Department of Defense (D0D). The news comes soon after AAHI announced that it had received an award of worth up to $9.9 million for development of … [Read more...] about AAHI gets $3 million for development of antiviral nasal spray

ENA Respiratory says interpretation of Phase 2a flu challenge study of INNA-051 antiviral nasal spray was “complicated” by pre-existing immunity

ENA Respiratory announced that "an unexpectedly large proportion of participants having pre-existing immunity to the challenge strain" resulted in difficulties interpreting data from a Phase 2a flu challenge study of its INNA-051 pegylated TLR2/6 agonist nasal spray. According to the company, dosing with "a substantial dose of H3N2 influenza A virus" failed to infect … [Read more...] about ENA Respiratory says interpretation of Phase 2a flu challenge study of INNA-051 antiviral nasal spray was “complicated” by pre-existing immunity

NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models

Researchers at North Carolina State University have published an article in Nature Materials describing preclinical development of an inhalation powder they are calling "SHIELD" (Spherical Hydrogel Inhalation for Enhanced Lung Defense) that has demonstrated the ability to block viral lung infections in mouse and non-human primate models. Studies found that the SHIELD … [Read more...] about NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models

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