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
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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
Positive results for Phase 3 study of intranasal esketamine for treatment-resistant depression
Janssen Pharmaceutical has announced that data from a Phase 3 study demonstrated significantly significant and clinically meaningful reduction of symptoms in adult patients with treatment-resistant depression who received esketamine nasal spray plus an oral antidepressant compared to those who received placebo plus an oral antidepressant. A second study in patients … [Read more...] about Positive results for Phase 3 study of intranasal esketamine for treatment-resistant depression
Phase 2b study of Staccato alprazolam for epilepsy gets underway
Engage Therapeutics has announced the initiation of the double-blind, randomized Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of inhaled alprazolam in epilepsy patients who have seizures with a predictable pattern. The company said that topline data should be available in the second half of 2019. The primary endpoint for the inpatient … [Read more...] about Phase 2b study of Staccato alprazolam for epilepsy gets underway
JDRF awards grant for intranasal insulin study
Leading diabetes research funder JDRF has awarded a 2-year $525,000 grant to International Diabetes Center (IDC) to support a study of intranasal insulin in Type 1 diabetes patients with hypoglycemia unawareness, the first time that JDRF has funded intranasal insulin research. JDRF has previously funded a study of Afrezza inhaled insulin used with an artificial … [Read more...] about JDRF awards grant for intranasal insulin study
AOBiome initiates Phase 2 trial of intranasal ammonia oxidizing bacteria for episodic migraine
A US biotech company called AOBiome Therapeutics said that it has initiated a Phase 2 study of an ammonia oxidizing bacteria (AOB) nasal spray for the prevention of episodic migraine. According to AOBiome, the nasal spray, which contains a single strain of Nitrosomonas eutropha, is expected to repopulate the nasal microbiome where it will convert naturally occurring … [Read more...] about AOBiome initiates Phase 2 trial of intranasal ammonia oxidizing bacteria for episodic migraine