Savara announced that it has halted two studies: the Phase 2a ENCORE study of Molgradex inhaled human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infections in cystic fibrosis patients and the Phase 3 AVAIL studies of AeroVanc vancomycin DPI for the treatment of MRSA lung infections in cystic … [Read more...] about Savara halts trials of Molgradex and Aerovanc due to COVID-19 pandemic
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Patient advocacy group expresses support for FDA approval of Savara’s Molgradex inhaled GM-CSF
The PAP Foundation, a US organization that advocates for pulmonary alveolar proteinosis (PAP) patients, says that it supports FDA approval of Savara's Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The group said that it expressed this opinion at the FDA's Rare Disease Day in February 2020 and is officially submitting … [Read more...] about Patient advocacy group expresses support for FDA approval of Savara’s Molgradex inhaled GM-CSF
Phase 3 trial of Milestone’s etripamil nasal spray for PSVT misses primary endpoint
Milestone Pharmaceuticals has reported that the Phase 3 NODE-301 trial of its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) has missed its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the five hours post dose. The NODE-301 trial, which was initiated in August 2018, enrolled 431 … [Read more...] about Phase 3 trial of Milestone’s etripamil nasal spray for PSVT misses primary endpoint
Windtree Therapeutics to study its KL4 surfactant for COVID-19
Windtree Therapeutics has announced that it plans to study its KL4 surfactant for the treatment of acute respiratory distress syndrome (ARDS) in patients suffering from COVID-19. Windtree's Aerosurf -- KL4 delivered via the company's proprietary Aerosol Delivery System (ADS) -- is in development for the treatment of respiratory distress syndrome (RDS) in premature … [Read more...] about Windtree Therapeutics to study its KL4 surfactant for COVID-19
Ampio takes steps toward testing nebulized Ampion anti-inflammatory biologic in COVID-19 patients
Ampio Pharmaceuticals announced that it plans to submit an expanded access protocol to the FDA to study the effects of a nebulized formulation of its Ampion anti-inflammatory biologic in patients with moderate to severe acute respiratory distress syndrome (ARDS) caused by COVID-19. The company said that it expects to evaluate the effectiveness of inhaled Ampion in … [Read more...] about Ampio takes steps toward testing nebulized Ampion anti-inflammatory biologic in COVID-19 patients
Biohaven’s intranasal vazegepant for migraine to advance into Phase 3 trials
Biohaven Pharmaceutical has announced that it met with the FDA following completion of Phase 2 clinical trials of its intranasal vazegepant (BHV-3500) for the treatment of migraine and is ready to advance the 10 mg dose of the nasal spray into a Phase 3 trial. In December 2019, Biohaven reported topline data from a Phase 2/3 dose finding trial in which both 10 and 20 … [Read more...] about Biohaven’s intranasal vazegepant for migraine to advance into Phase 3 trials
Synairgen announces trial of SNG001 inhaled interferon-beta-1a for COVID-19
The UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have expedited approvals for a Phase 2 trial of Synairgen's SNG001 nebulized interferon-beta-1a for the treatment of COVID-19, the company said. According to the company, coronaviruses like SARS-CoV-2 have the ability to interfere with production of endogenous … [Read more...] about Synairgen announces trial of SNG001 inhaled interferon-beta-1a for COVID-19
Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
Beyond Air said that it has submitted an investigational device exemption (IDE) to the FDA seeking to use its cylinder-free LungFit BRO inhaled nitric oxide (iNO) delivery system for the treatment of COVID-19. Beyond Air has been developing the LungFit BRO system for the treatment of bronchiolitis. The company said that if the FDA approves the IDE, it will conduct … [Read more...] about Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
Engage Therapeutics reports positive results from Phase 2 study of Staccato alprazolam for epileptic seizures
Engage Therapeutics said that the Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of Staccato inhaled alprazolam in epilepsy patients has met its primary endpoint, terminating seizure activity within two minutes of dosing with no recurrence in 50 of 76 patients. Engage had announced the initiation of the study in April … [Read more...] about Engage Therapeutics reports positive results from Phase 2 study of Staccato alprazolam for epileptic seizures
Otitopic announces planned PK/PD study of its Asprihale aspirin DPI
Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020. Results are expected by the end of 2021, the company said. Otitopic is developing Asprihale for the treatment of myocardial infarction and has indicated that it … [Read more...] about Otitopic announces planned PK/PD study of its Asprihale aspirin DPI