Levo Therapeutics has announced that it plans to initiate a Phase 3 trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) before the end of 2018. The company said that it acquired rights to the formulation from Ferring Pharmaceuticals in August 2017 and is now publishing results from a Phase 2 study sponsored by Ferring that concluded … [Read more...] about Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome
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Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a pre-IND meeting for AB569. The study began recruiting volunteers in February 2018. Arch Biopartners CEO Richard Muruve said, “We have … [Read more...] about Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations
Insys Therapeutics said that preliminary data from a Phase 1 pharmacokinetics study comparing its intranasal epinephrine formulation to EpiPen intramuscular epinephrine in 60 subjects with seasonal allergies showed similar bioavailability and rapid drug absorption for the nasal spray. The company did not provide any details. Insys announced initiation of the study … [Read more...] about Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations
Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI
Data from a Phase 1 study of Pulmatrix's PUR0200 lactose-free dry powder formulation of tiotropium has been published online in the British Journal of Clinical Pharmacology. The dose-ranging study in patients with moderate-to-severe COPD compared 3 doses of PUR0200 (3 μg, 6 μg, or 9 μg) to Spriva Handihaler (18 μg) and placebo. All doses of PUR0200 produced a … [Read more...] about Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI
Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Spyryx Biosciences has announced that data from the first cohort of the Phase 2 HOPE-1 (Hydration for Optimal Pulmonary Effectiveness) study, which was initiated in October 2017, demonstrate improvement in lung function for cystic fibrosis patients independent of type of CF mutation after treatment with SPX-101, an inhaled SPLUNC1-derived peptide. The 46 patients … [Read more...] about Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Impel NeuroPharma initiates Phase 2a study of INP103 intranasal levodopa for Parkinson’s disease
Impel NeuroPharma has announced the initiation of the Phase 2a THOR 201 study of INP103 intranasal levodopa compared to placebo for the treatment of OFF episodes in Parkinson's disease patients. INP103 is delivered by Impel's Precision Olfactory Delivery (POD) device. The safety and PK/PD study is expected to enroll 24 patients who will receive one of 3 doses of … [Read more...] about Impel NeuroPharma initiates Phase 2a study of INP103 intranasal levodopa for Parkinson’s disease
Apotex recalls lot of fluticasone nasal spray in US
Apotex has issued a voluntarily recall for one lot of fluticasone propionate nasal spray (lot NJ4501), which was shipped to wholesalers and distributors throughout the US and has an expiration date of July 2020. Apotex said that the FDA is aware of the recall and wholesalers and distributors have been notified. According to the company, a consumer complaint … [Read more...] about Apotex recalls lot of fluticasone nasal spray in US
Savara announces good results for Molgradex treatment in two CF patients with NTM lung infections
Savara has updated two case reports published in the European Respiratory Journal in April 2018 that describe the treatment of nontuberculous mycobacterial (NTM) lung infection Mycobacterium abscessus using Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with cystic fibrosis. M. abscessus is a multidrug … [Read more...] about Savara announces good results for Molgradex treatment in two CF patients with NTM lung infections
Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Vast Therapeutics, which recently changed its name from Novoclem Therapeutics, has announced that its BIOC51 dry powder nitric oxide (NO)-release formulation reduced the bacterial load of nontuberculous mycobacteria (NTM) in the lungs of mice by 99% in a study conducted with Colorado State University. According to the company, BIOC51 has eradicated every bacterial … [Read more...] about Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study
Windtree Therapeutics has received the remaining $700,000 from a Small Business Innovation Research Grant (SBIR) from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) that was initially awarded in 2016 for Phase 2 development of Aerosurf. The company previously received a total of $1.9 million from that award, an … [Read more...] about Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study