Pulmocide announced that the Phase 2 OPERA-S study of PC945 inhaled opelconazole in lung transplant patients demonstrated that the inhalation suspension was generally safe and well tolerated, with no subjects needing to discontinue or reduce medications due to interactions with immunosuppressant drugs. Pulmocide is developing PC945, which has been granted orphan drug, … [Read more...] about Pulmocide says that Phase 2 trial demonstrated safety and tolerability of inhaled opelconazole
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Kexing Biopharm initiates Phase 3 trial of human interferon α1b inhalation solution
Kexing Biopharm announced that has initiated a Phase 3 trial of human Interferon α1b inhalation solution, which the company is developing for the treatment of children with pneumonia or bronchiolitis associated with respiratory syncytial virus. According to Kexing, a Phase 1 trial of the inhalation solution was completed in October 2023 and demonstrated low systemic … [Read more...] about Kexing Biopharm initiates Phase 3 trial of human interferon α1b inhalation solution
Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
Chiesi has announced the initiation of a Phase 3 safety study of CHF5993 beclometasone / formoterol / glycopyrronium HFA 152a MDI, an LGWP propellant version of Trimbow MDI, which uses HFA 134a as a propellant. In December 2019, Chiesi announced that it planned to bring an HFA 152a inhaler to market by the end of 2025. The Phase 3 trial will compare the HFA 152a … [Read more...] about Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
The Cystic Fibrosis Foundation announced that it making an additional investment of up to $8.5 million to support a Phase 2 trial of SpliSense's nebulized SPL84 antisense oligonucleotide in patients with cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has received Orphan Drug designation from both the EMA and the FDA. According to SpliSense, the … [Read more...] about SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
Vistagen initiates Phase 3 PALISADE-3 trial of fasedienol nasal spray in people with social anxiety disorder
Vistagen has announced the initiation of the Phase 3 PALISADE-3 public speaking trial of fasedienol (PH94B) nasal spray in people with social anxiety disorder. In August 2023, the company announced that the Phase 3 PALISADE-2 trial had met its primary endpoint although that study was closed early and enrolled only about 2/3 of the expected number of subjects. The … [Read more...] about Vistagen initiates Phase 3 PALISADE-3 trial of fasedienol nasal spray in people with social anxiety disorder
Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth
Launch Therapeutics will take over management of clinical trials of Teva’s TEV-‘248 fluticasone / albuterol (salbutamol) DPI for the treatment of asthma, the companies have announced. In addition, Carlyle Group subsidiary Abingworth, a Launch Therapeutics backer, will invest up to $150 million toward funding continued development of TEV-'248 and would receive … [Read more...] about Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth
Beckley announces data from Phase 2a trial of BPL-003 intranasal dry powder synthetic 5-MeO-DMT in people with treatment resistant depression.
Beckley Psytech says that more than half of people with moderate-to-severe treatment resistant depression who received a single 10mg dose of BPL-003 intranasal synthetic dry powder 5-MeO-DMT (mebufotenin) in a Phase 2a trial experienced a reduction in depressive symptoms and almost half remained in remission at day 85 post dose. The Phase 2a study, which was initiated … [Read more...] about Beckley announces data from Phase 2a trial of BPL-003 intranasal dry powder synthetic 5-MeO-DMT in people with treatment resistant depression.
Intravacc announces data from Phase 1 study of Avacc 10 intranasal SARS-CoV-2 vaccine as a booster
Intravacc has announced that a Phase 1 study of Avacc 10 intranasal vaccine as a booster against SARS-CoV-2 induced a mucosal response in subjects who received the higher of two doses tested, and the vaccine was well tolerated. The company announced in November 2022 that it was initiating the Phase 1 study of Avacc 10. According to Intravacc, the study enrolled 36 … [Read more...] about Intravacc announces data from Phase 1 study of Avacc 10 intranasal SARS-CoV-2 vaccine as a booster
Blue Lake announces preliminary data from Phase 1/2a trial of BLB201 intranasal RSV vaccine in young children
Blue Lake Biotechnology has announced initial results from a Phase 1/2a clinical trial of its BLB201 intranasal vaccine against severe respiratory syncytial virus disease in children aged 8 months to 59 months with or without prior RSV infection. The company has previously announced results from a Phase 1 trial BLB201 in adults aged 18-59 and 60-75. In 2022, the FDA … [Read more...] about Blue Lake announces preliminary data from Phase 1/2a trial of BLB201 intranasal RSV vaccine in young children
Inhalon reports data from Phase 1b trial of IN-006 inhaled regdanvimab
Inhalon Biopharma announced that a Phase 1b study that evaluated the company's IN-006 nebulized regdanvimab in healthy volunteers demonstrated successful delivery of the inhaled antibodies throughout the respiratory tract, achieving uniform distribution and significantly higher concentrations than for intravenous regdanvimab. The study was funded by the United States … [Read more...] about Inhalon reports data from Phase 1b trial of IN-006 inhaled regdanvimab