Medical

Novartis has announced that its Phase 3 PALLADIUM trial of QMF149 indacaterol acetate/mometasone furoate (IND/MF) delivered via the Breezhaler DPI in patients with uncontrolled asthma met its primary endpoint, demonstrating superior improvement in lung function after 26 weeks compared to mometasone furoate alone. The company said that its MAA for QMF149 has been … [Read more...] about Novartis reports positive results from Phase 3 study of QMF149 for asthma

Noveome Biotherapeutics said that it has initiated a Phase 1 safety trial of its ST266 secretome delivered intranasally in patients with intraocular hypertension. The study will use a device from SipNose designed to deliver drugs across the blood-brain barrier to deliver ST266. Noveome is developing ST266 in several dosage forms, with intranasal ST266 also in … [Read more...] about Noveome initiates Phase 1 safety trial of intranasal biologic for delivery to the optic nerve

Santhera Pharmaceuticals has announced the publication of data from two Phase 1 studies of its POL6014 inhaled human neutrophil elastase (hNE) inhibitor in the Journal of Cystic Fibrosis. According to the company, inhalation of nebulized POL6014 resulted in a rapid reduction of hNE in the sputum of cystic fibrosis patients, with high lung concentrations of POL6014 … [Read more...] about Santhera publishes data from Phase 1 study of its inhaled hNE inhibitor

Tiziana Life Sciences has announced that a Phase 1 clinical trial of its intranasal Foralumab human anti-CD3 monoclonal antibody was well tolerated at doses of 10, 50 and 250 µg per day and demonstrated "significant positive immune effects." The company is developing intranasal Foralumab, which it licensed from Novimmune in 2014, for the treatment of neurodegenerative … [Read more...] about Tiziana announces Phase 1 results for intranasal Foralumab

Theravance Biopharma has announced positive results from a Phase 1 single-ascending dose and multiple-ascending dose trial of its TD-8236 pan-JAK inhibitor DPI for the treatment of inflammatory lung diseases. The company had announced initiation of the study in November 2018. According to Theravance Biopharma, a single dose of up to 4500 μg of TD-8236 was … [Read more...] about Positive Phase 1 results for Theravance Biopharma’s inhaled JAK inhibitor for lung disease

Janssen Pharmaceutical Companies has announced that both the ASPIRE I & ASPIRE II Phase 3 clinical studies of esketamine nasal spray in addition to standard of care (SOC) for the treatment of major depressive disorder in adult patients with active suicidal ideation with intent have met their primary endpoints. In both studies, the nasal spray plus SOC demonstrated … [Read more...] about Janssen publishes positive Phase 3 results for Spravato esketamine nasal spray in patients with suicidal intent

AstraZeneca said that the 52-week Phase 3 ETHOS trial of its Breztri Aerosphere (formerly PT010) budesonide/glycopyrronium/formoterol fumarate MDI in more than 8,500 patients with moderate to very severe COPD and a history of exacerbations within the past year has met its primary endpoint. The trial, which compared Breztri Aerosphere to Bevespi Aerosphere … [Read more...] about Phase 3 trial of Breztri Aerosphere meets primary endpoint

Satsuma Pharmaceuticals announced that it has initiated the Phase 3 EMERGE trial of STS101 dihydroergotamine (DHE) nasal powder for the acute treatment of migraine. In April 2019, Satsuma announced that it had raised $62 million to fund Phase 3 development of STS101. The study, which is expected to enroll approximately 1,140 migraine patients, will compare two … [Read more...] about Satsuma initiates Phase 3 study of intranasal DHE for the treatment of migraine

Verona Pharma has announced that a Phase 2 trial of its RPL554 ensifentrine DPI for the treatment of COPD met all primary and secondary endpoints related to improvement in lung function. The company had previously announced positive preliminary results from the study. Phase 2 studies of nebulized ensifentrine and an ensifentrine MDI for the treatment of COPD were … [Read more...] about Positive Phase 2 results for ensifentrine DPI for COPD

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