AZTherapies has announced the initiation of a Phase 2a clinical trial of its ALZT-OP1a inhaled cromolyn in patients with mild- to moderate-stage amyotrophic lateral sclerosis (ALS). The randomized open-label trial is expected to enroll 80 ALS patients who will receive, in addition to standard of care, either 17.1 mg of cromolyn via DPI twice a day or 34.2 mg twice a … [Read more...] about AZTherapies announces initiation of Phase 2a trial of inhaled cromolyn for ALS
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Marinomed submits MAA for xylometazoline decongestant nasal spray
Marinomed Biotech said that it has submitted an MAA via the decentralized marketing authorization procedure for a xylometazoline decongestant nasal spray formulated with the company's Carragelose red algae extract. The company currently markets a range of non-prescription nasal sprays based on Carragelose, including Coldamaris; the xylometazoline spray will be its … [Read more...] about Marinomed submits MAA for xylometazoline decongestant nasal spray
Destiny Pharma and SporeGen get £800,000 grant for bacillus nasal spray for prevention of COVID-19
Destiny Pharma and SporeGen have agreed to co-develop a bacillus nasal spray as a prophylactic for prevention of COVID-19, with much of the project cost covered by an £800,000 grant from Innovate UK. Pan Group subsidiary Huro will develop and manufacture the formulation, and the companies say that they expect to begin clinical trials by early 2022. Preclinical … [Read more...] about Destiny Pharma and SporeGen get £800,000 grant for bacillus nasal spray for prevention of COVID-19
Verona initiates trial of ensifentrine MDI in hospitalized COVID-19 patients
Verona Pharma has initiated a study of its ensifentrine MDI in patients hospitalized with COVID-19 at the University of Alabama Birmingham (UAB), the company said. The company has been developing the MDI formulation for the treatment of COPD and recently initiated a Phase 2b trial for that indication after a delay caused by the pandemic. Verona also has nebulized and … [Read more...] about Verona initiates trial of ensifentrine MDI in hospitalized COVID-19 patients
Diomics licenses Active Motif antibodies for COVID-19 nasal spray
US biotech Diomics Corporation has announced plans to develop a prophylactic nasal spray against COVID-19 using antibodies licensed from Active Motif. According to the company, the Dioguard nasal spray, currently in in vitro testing, uses nanobeads made from the company's Diomat biopolymer loaded with Active Motif's 414-1 human IgG monoclonal antibodies. Diomics … [Read more...] about Diomics licenses Active Motif antibodies for COVID-19 nasal spray
FDA agrees to new Phase 2 trial design for Aridis’ AR-501 inhaled gallium for CF
According to Aridis Pharmaceuticals, the FDA has agreed to allow a Phase 2a trial of the company's AR-501 nebulized formulation of gallium citrate for the treatment of lung infections in cystic fibrosis patients to skip a SAD study and move directly into a multiple ascending dose study. Aridis said that it proposed the new design after successfully completing a Phase … [Read more...] about FDA agrees to new Phase 2 trial design for Aridis’ AR-501 inhaled gallium for CF
Auris reports positive topline data from Phase 2a trial of intranasal betahistine for vertigo
Auris Medical said that the first part of the Phase 2 TRAVERS study of its AM-125 intranasal betahistine for the treatment of vertigo has demonstrated a dose dependent improvement in balance up to 2.4 times greater than placebo at the highest dose. The company had announced the initiation of the TRAVERS trial in July 2019. The 4-week trial evaluated 1, 10, or 20 … [Read more...] about Auris reports positive topline data from Phase 2a trial of intranasal betahistine for vertigo
Savara discontinues development of Molgradex for NTM lung infections
Savara has discontinued development of Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection and will not restart the Phase 2a ENCORE study of Molgradex for NTM in cystic fibrosis patients, the company said. Development of Molgradex for the treatment of … [Read more...] about Savara discontinues development of Molgradex for NTM lung infections
MediciNova announces development plans for intranasal SARS-CoV-2 vaccine
MediciNova said that it has tested a number of intranasal SARS-CoV-2 vaccine prototypes using a viral vector technology platform from Mie University and BioComo and has identified several candidates that it plans to advance. BioComo's BC-PIV vaccine carrier is based on recombinant human parainfluenza virus 2 (hPIV2) vectors. According to MediciNova, the intranasal … [Read more...] about MediciNova announces development plans for intranasal SARS-CoV-2 vaccine
Partner Therapeutics initiates Phase 2 trial of inhaled sargramostim for COVID-19
Partner Therapeutics (PTx) has announced the initiation of the iLeukPulm Phase 2 trial of an inhaled formulation of its Leukine sargramostim in hospitalized COVID-19 patients in respiratory distress. Partner recently signed a $35 million contract with the US Department of Defense for development of Leukine for the treatment of COVID-19. PTx acquired Leukine, a … [Read more...] about Partner Therapeutics initiates Phase 2 trial of inhaled sargramostim for COVID-19