MannKind Corporation says that it will move ahead with a Phase 1 SAD/MAD study of MNKD-201 dry powder nintedanib for inhalation, which the company is developing for the treatment of fibrotic diseases of the lung, including idiopathic pulmonary fibrosis (IPF). The trial is expected to begin enrolling healthy volunteers in June 2024. MannKind CEO Michael Castagna … [Read more...] about MannKind announces plans for Phase 1 study of MNKD-201 nintedanib DPI
Medical
FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM
MannKind Corporation announced that the FDA has cleared the company's IND for the ICoN-1 Phase 3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). The company said that it expects to initiate the study in the US by mid-2024 and elsewhere by the end of the … [Read more...] about FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM
FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
According to ENA Respiratory, the FDA has cleared the company's IND for a Phase 1b study of a dry powder formulation of INNA-051, a TLR2/6 agonist, which the company has been developing as a pan-viral nasal spray. ENA said that it expects the study to begin in mid-2024. Development of the dry powder formulation is partially funded by the US Department of Defense … [Read more...] about FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
Krystal Biotech initiates Phase 1 trial of inhaled KB707 gene therapy in patients with solid lung tumors
Krystal Biotech has announced the initiation of the KYANITE-1 Phase 1 trial of inhaled KB707 gene therapy in patients with advanced solid lung tumors. Inhaled KB707 received Fast Track designation from the FDA for this indication earlier this year. The open-label KYANITE-1 dose escalation and dose expansion study is expected to enroll 80 patients who will received … [Read more...] about Krystal Biotech initiates Phase 1 trial of inhaled KB707 gene therapy in patients with solid lung tumors
Pulmocide says that Phase 2 trial demonstrated safety and tolerability of inhaled opelconazole
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
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