Medical

Oragenics said that results from a toxicology study of its NT-CoV2-1 intranasal vaccine conducted in rabbits "confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study." In June 2022, the company published data from preclinical studies of NT-CoV2-1 in mice and hamsters … [Read more...] about Oragenics says no indication of toxicity for its NT-CoV2-1 intranasal vaccine candidate

Biotech Orgenesis and nasal delivery specialist Kurve Therapeutics have announced results from a preclinical study of an intranasal "cell-based oncolytic virus bearing product" in a mouse model of glioblastoma. Orgenesis says that it manufactured the product on behalf of "a premier cell therapy development company." According to the companies, delivery of the product … [Read more...] about Orgenesis and Kurve say preclinical study demonstrated that intranasal cell therapy reduced tumors by 50% in a mouse model of glioblastoma

According to Beckley Psytech, the company has initiated a Phase 2a study of its BPL-003 intranasal dry powder 5-MeO-DMT for the treatment of moderate-to-severe treatment-resistant depression. Beckley Psytech recently reported results from a Phase 1 study showing a dose proportional PK profile for BPL-003; that study also found that any consciousness-altering effects … [Read more...] about Beckley Psytech initiates Phase 2a study of BPL-003 intranasal dry powder 5-MeO-DMT for treatment-resistant depression

Israel-based SpliSense said that it has initiated a Phase 1/2 trial of its SPL84 inhaled anti sense oligonucleotide for the treatment of cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has been granted Orphan Drug designation from both the EMA and the FDA. The company said that the SAD portion of the trial will evaluate SPL84 in healthy … [Read more...] about SpliSense initiates Phase 1/2 trial of SPL84 inhaled antisense oligonucleotide for CF

Verona Pharma announced that the Phase 3 ENHANCE-1 trial of nebulized ensifentrine for the treatment of COPD met its primary endpoint, demonstrating an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 87 ml at week 12, as well as consistent improvement for all subgroups. Patients receiving ensifentrine also had a 36% lower rate of moderate to severe … [Read more...] about Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine

Gossamer Bio has announced that the TORREY Phase 2 study of its GB002 seralutinib DPI for the treatment of pulmonary arterial hypertension (PAH) met its primary endpoint, demonstrating a statistically significant change in pulmonary vascular resistance (PVR) at Week 24. According to Gossamer, "Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and … [Read more...] about Phase 2 study of Gossamer Bio’s Seralutinib DPI for PAH meets primary endpoint

Intravacc announced that it has initiated a Phase 1 trial of Avacc 10 intranasal SARS-CoV-2 subunit vaccine, which the company is developing as a booster. Avacc 10 is based on the same outer membrane vesicles (OMV) technology as the company's intranasal vaccines against gonorrhea and betacoronavirus vaccines. Intravacc had announced in June 2020 that it would develop … [Read more...] about Intravacc initiates Phase 1 trial of Avacc 10 intranasal vaccine as a COVID-19 booster