Medical

AZ Therapies has announced that the Phase 3 COGNITE study of ALZT-OP1 inhaled cromolyn/oral ibuprofen for the treatment of early stage Alzheimer’s disease has completed enrollment. The company, which announced the initiation of the study in September 2015, said that it has a special protocol assessment (SPA) agreement with the FDA regarding the trial design. … [Read more...] about Enrollment in Phase 3 study of ALZT-OP1 inhaled Alzheimer’s therapy completed

Auris Medical has announced the initiation of the Phase 2 TRAVERS trial of its AM-125 intranasal betahistine for the treatment of acute vertigo resulting from removal of a vestibular schwannoma.  Auris is also developing intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome and said that it has completed enrollment in a Phase 1b … [Read more...] about Auris Medical initiates Phase 2 trial of intranasal betahistine for acute vertigo

Oyster Point Pharma has announced the initiation of the Phase 3 ONSET-2 study of its OC-01 nicotine acetylcholine receptor (nAChR) agonist nasal spray for the treatment of dry eye disease. In October 2018, the company announced positive Phase 2b results for both OC-01 and OC-02 nasal sprays for that indication. Earlier this year, Oyster Point said that it had raised … [Read more...] about Oyster Point initiates Phase 3 trial of nasal spray for dry eye disease

Pulmatrix has announced the initiation of a Phase 2 clinical trial of Pulmazole inhaled itraconazole (PUR1900) for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma, with top line data expected in mid 2020. Cip Tech acquired rights to Pulmazole for this indication earlier this year, in a deal conditioned on Pulmatrix's ability to … [Read more...] about Pulmatrix initiates Phase 2 trial of Pulmazole for ABPA in patients with asthma

Inhaled drug developer Savara has announced that the Phase 3 IMPALA study of Molgradex inhaled formulation recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) failed to meet its primary endpoint, improvement in alveolar-arterial oxygen gradient (A-aDO2). The study … [Read more...] about Phase 3 study of Molgradex inhaled GM-CSF for the treatment of aPAP fails to meet primary endpoint

During the 2019 annual meeting of the American Diabetes Association (ADA),  Dance Biopharm presented data from the Phase 2 Samba 04 clinical trial of Dance 501 inhaled insulin for the treatment of Type 2 diabetes demonstrating that Dance 501 had a more rapid onset of action than subcutaneous insulin lispro. The Samba 04 study enrolled 24 Type 2 patients who were … [Read more...] about Dance Biopharm presents positive Phase 2 results for Dance 501 inhaled insulin

Verona Pharma has initiated a Phase 2 trial of the MDI formulation of RPL554 ensifentrine in COPD patients, the company said. Verona recently announced the initiation of a Phase 2b study of nebulized ensifentrine and interim results from a Phase 2 study of the DPI formulation for COPD. The Phase 2 study of the MDI formulation is expected to enroll 36 patients with … [Read more...] about Verona Pharma initiates Phase 2 trial of RPL554 ensifentrine MDI

ARS Pharmaceuticals has announced results from the EPI-04 clinical study demonstrating that the company's ARS-1 intranasal epinephrine spray has a pharmacokinetic profile that is similar to intramuscular epinephrine. ARS is developing ARS-1 for the treatment of anaphylaxis, and ARS-1 received Fast Track Designation for that indication earlier this year. The EPI-04 … [Read more...] about Study shows ARS-1 intranasal epinephrine has similar PK profile to intramuscular epinephrine