Novus Therapeutics said that it has initiated a Phase 1 clinical trial of OP0201, an intranasal surfactant that the company is developing for the treatment of otitis media. The 2-week study will evaluate daily administration of 30 mg and 60 mg doses of OP0201, delivered intranasally via MDI, in 30 healthy adults. Earlier this year, the company announced that it had … [Read more...] about Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway
Medical
Theravance initiates Phase 1 trial of TD-8236 inhaled JAK inhibitor
According to Theravance Biopharma, the first subject has been dosed in a Phase 1 clinical trial of TD-8236, a JAK inhibitor that the company is developing as a DPI for the potential treatment of asthma, COPD, and other respiratory diseases. The company said that in preclinical studies, TD-8236 has demonstrated inhibition of JAK/STAT cytokines in disease relevant … [Read more...] about Theravance initiates Phase 1 trial of TD-8236 inhaled JAK inhibitor
Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development
Vectura has announced that a Phase 3 study of VR475 budesonide inhalation suspension for the treatment of severe uncontrolled asthma in adult and adolescent patients failed to meet its primary endpoint. As a result, the company said that it would discontinue development of VR475 (formerly known as Favolir), which it acquired when it acquired Activaero in … [Read more...] about Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development
Pulmatrix announces plans for Phase 2 study of Pulmazole itraconazole DPI
Pulmatrix said that based on final results from a Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI, which it is developing for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company now plans to begin a Phase 2 trial by the end of the year. The company previously reported top line data from the study showing … [Read more...] about Pulmatrix announces plans for Phase 2 study of Pulmazole itraconazole DPI
InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
InCarda Therapeutics has announced the completion of an oversubscribed $42 million Series B financing that will fund a Phase 2 study of InRhythm inhaled flecainide for the treatment of recent-onset paroxysmal atrial fibrillation (PAF). The financing round was led by Sofinnova and HealthCap, both new investors along with Deerfield Management. In 2015, InCarda raised … [Read more...] about InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
Acerus Pharmaceuticals initiates Phase 1 study of intranasal cannabis oil
Acerus Pharmaceuticals has announced the initiation of a Phase 1 clinical trial of an intranasal formulation of cannabis oil, which the company said is "a preliminary step in a broader strategy focused on identifying additional applications for Acerus’ proprietary nasal delivery technology, including for prescription medical marijuana." The company has developed … [Read more...] about Acerus Pharmaceuticals initiates Phase 1 study of intranasal cannabis oil
Positive Phase 2b results for both Oyster Point nasal sprays for dry eye disease
Oyster Point Pharma has announced that separate Phase 2b studies of its OC-01 and OC-02 nicotine acetylcholine receptor (nAChR) agonist nasal sprays for the treatment of dry eye disease both showed improvement in dry eye symptoms for patients using the nasal sprays. Positive results for a previous Phase 2b trial of OC-2 were announced in July 2018. Oyster Point … [Read more...] about Positive Phase 2b results for both Oyster Point nasal sprays for dry eye disease
Biohaven Pharmaceutical initiates Phase 1 study of intranasal migraine candidate
Biohaven Pharmaceutical said that it has initiated a Phase 1 trial of its BHV-3500, an intranasal calcitonin gene-related peptide (CGRP) receptor antagonist delivered via the Aptar Pharma Unit Dose System after the FDA approved its IND. The trial will evaluate various doses of BHV-3500, which the company is developing for the treatment of migraine.The company … [Read more...] about Biohaven Pharmaceutical initiates Phase 1 study of intranasal migraine candidate
Positive Phase 1 results for Auris Medical’s intranasal betahistine
Auris Medical has announced results from a second Phase 1 study of its intranasal betahistine in 72 healthy volunteers that demonstrated superior bioavailability compared to oral betahistine for 4 doses of the nasal formulation, with plasma exposure up to 29 times higher. Earlier this year, Auris announced results from an earlier Phase 1 study and a pre-clinical … [Read more...] about Positive Phase 1 results for Auris Medical’s intranasal betahistine
Group developing inhaled antisense therapy for IPF gets funding through EuroNanoMed3
Secarna Pharmaceuticals has announced that the Inhaled Nanocarriers with Antisense Therapy for lung fibrosis (INAT) project has received a 3-year grant to fund from the ERA-Net Cofund EuroNanoMed3, part of the EC's Horizon 2020 Framework Program for Research and Innovation. Secarna is part of a consortium for INAT that includes French, German, and Belgian universities … [Read more...] about Group developing inhaled antisense therapy for IPF gets funding through EuroNanoMed3