Anindya Roy, a researcher at the University of Washington Institute for Protein Design (IPD), has received a $250,000 grant from Washington Research Foundation (WRF) for continued development of an inhaled miniprotein binder for the treatment of idiopathic pulmonary fibrosis (IPF), WRF has announced. According to WRF, Roy's miniprotein binds to the αvβ6 integrin, … [Read more...] about Washington Research Foundation awards grant for development of inhaled miniprotein for IPF
Medical
Atossa announces Phase 1/2a study of nebulized AT-H201
Atossa Therapeutics said that the Human Research Ethics Committee (HREC) of the Australian National Health and Medical Research Council (NHMRC) has okayed a Phase 1/2a clinical study of the company's nebulized AT-H201, which is "is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes." The … [Read more...] about Atossa announces Phase 1/2a study of nebulized AT-H201
PureIMS, Sever Pharma Solutions, and Radboudumc partner on development of tigecycline DPI
Dutch DPI developer Pure IMS has announced a new partnership with CDMO Sever Pharma Solutions (formerly Disphar International) and Radboud University Medical Center (Radboudumc) for development of a tigecycline dry powder inhaler for the treatment of multi-drug resistant Mycobacterium abscessus lung infections. Radboudumc research has demonstrated that inhaled … [Read more...] about PureIMS, Sever Pharma Solutions, and Radboudumc partner on development of tigecycline DPI
FluGen gets funding from US Department of Defense for intranasal flu vaccine
FluGen said that it has received an $11.4 million grant from the United States Department of Defense for a Phase 1b study to evaluate the ability of its M2SR intranasal flu vaccine to protect against a variety of flu strains, including those like H3N2 that are mismatched to current vaccines. In February 2019, FluGen announced that a Phase 2 trial of the M2SR vaccine … [Read more...] about FluGen gets funding from US Department of Defense for intranasal flu vaccine
Savara initiates new Phase 3 trial of molgramostim inhaled GM-CSF for aPAP
Savara has announced the initiation of the Phase 3 IMPALA-2 clinical trial of molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). In December 2020, the company stopped development of the AeroVanc vancomycin DPI and Apulmiq (Linhaliq) inhaled … [Read more...] about Savara initiates new Phase 3 trial of molgramostim inhaled GM-CSF for aPAP
Altimmune halts development of AdCOVID intranasal vaccine, terminates trial of T-COVID intranasal therapeutic
Altimmune has discontinued development of its AdCOVID intranasal vaccine for the prevention of COVID-19 after the failure of a Phase 1 trial and has stopped enrollment in a Phase 1/2 trial of its T-COVID intranasal therapy for COVID-19 the company said. The FDA had cleared the IND for the Phase 1 trial of AdCOVID in February 2021; the Phase 1/2 trial of T-COVID was … [Read more...] about Altimmune halts development of AdCOVID intranasal vaccine, terminates trial of T-COVID intranasal therapeutic
Ampio initiates Phase 2 trial of inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals has announced the initiation of the AP-019 Phase 2 clinical trial of inhaled Ampion for the treatment of respiratory distress in patients with COVID-19. The company said that it has also received the okay from the FDA to add at least one trial site in India which currently has a high incidence of COVID-19; the initial location was in the US. … [Read more...] about Ampio initiates Phase 2 trial of inhaled Ampion in COVID-19 patients
Aerami initiates Phase 1 trial of AER-901 inhaled imatinib for PAH
Aerami Therapeutics said that it has initiated dosing in a Phase 1 clinical trial of its AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH). According to the study description on clinicaltrials.gov, the SAD/MAD trial is expected to enroll 78 healthy volunteers and is expected to evaluate doses of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg in … [Read more...] about Aerami initiates Phase 1 trial of AER-901 inhaled imatinib for PAH
Positive results from Phase 1 trial of Nasus Pharma’s intranasal dry powder epinephrine
Nasus Pharma said that a Phase 1 PK study of its FMXIN002 intranasal dry powder epinephrine demonstrated that FMXIN002 could produce a maximum plasma level comparable to that of epinephrine delivered via EpiPen and reached that level significantly faster than the injection. The open-label SAD study enrolled 12 volunteers and compared 1.6 and 3.2 mg doses of FMXIN002 … [Read more...] about Positive results from Phase 1 trial of Nasus Pharma’s intranasal dry powder epinephrine
Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint
Theravance Biopharma said that a Phase 2 study of its inhaled nezulcitinib (TD-0903) pan-JAK inhibitor in hospitalized COVID-19 patients failed to meet its primary endpoint of respiratory failure free days at Day 28. The study did demonstrate some improvement in all-cause mortality, and in patients with C-reactive protein levels below 150 mg/L, nezulcitinib … [Read more...] about Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint