Altimmune announced that it has raised $14 million in a registered direct offering, with net proceeds of about $12.7 million. The company also said that an extension of a Phase 2 study of its NasoVax intranasal flu vaccine found that subjects were still protected against the flu more than a year after vaccination. The company said that 8 subjects from the original … [Read more...] about Altimmune announces new funding, positive results for NasoVax flu vaccine
Medical
Phase 3 trial of Liquidia’s inhaled treprostinil meets primary endpoint
Liquidia Technologies has announced that the Phase 3 INSPIRE study of its LIQ861 DPI in pulmonary arterial hypertension (“PAH”) patients met its primary endpoint. In January 2019, the company announced encouraging preliminary results from the study. According to Liquidia, the 2-month study, which enrolled 109 patients, demonstrated that doses of up to 150 mcg of … [Read more...] about Phase 3 trial of Liquidia’s inhaled treprostinil meets primary endpoint
Verona announces positive interim data from Phase 2 study ensifentrine DPI
Verona Pharma said that it plans to initiate the second phase of a two-part Phase 2 trial of its RPL554 ensifentrine DPI in COPD patients after the first part of the study demonstrated that the DPI produced significant improvement in FEV1. The company announced initiation of the study in December 2018. The Phase 2 study enrolled 37 moderate-to-severe COPD patients … [Read more...] about Verona announces positive interim data from Phase 2 study ensifentrine DPI
Opiant stops development of OPNT001 naloxone nasal spray for the treatment of bulimia
Opiant Pharmaceuticals said that it has discontinued development of OPNT001 naloxone nasal spray for the treatment of bulimia nervosa (BN) after a Phase 2 study failed to meet its primary endpoint. The company had announced the initiation of the study in March 2017. Opiant CEO Roger Crystal commented, “Based on these results, Opiant will not allocate further … [Read more...] about Opiant stops development of OPNT001 naloxone nasal spray for the treatment of bulimia
Satsuma announces Phase 1 results, plans for Phase 3 trial of its intranasal DHE for the treatment of migraine
Satsuma Pharmaceuticals, which was spun out from SNBL in 2017 specifically for the purpose of developing STS 101 intranasal dihydroergotamine (DHE) for the treatment of migraine, said that a Phase 1 clinical trial demonstrated that STS101 was well tolerated, with none of the typical side effects of injected DHE such as nausea and vomiting. STS101 was rapidly absorbed … [Read more...] about Satsuma announces Phase 1 results, plans for Phase 3 trial of its intranasal DHE for the treatment of migraine
Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus
FluGen has announced that preliminary data from a Phase 2 trial show that its intranasal M2SR manufactured with a strain of influenza that was used in vaccines during the 2008-2010 influenza seasons protected against a live H3N2 influenza virus from the 2014-15 flu season. Demonstrating protection against the highly mismatched virus is a "major step toward … [Read more...] about Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus
FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI
The FDA has cleared Pulmatrix's investigational new drug application, giving the company the go-ahead to begin a Phase 2 clinical trial of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. In November 2018, Pulmatrix said that it planned to initiate a Phase 2 trial by the end … [Read more...] about FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI
Biohaven announces plans for Phase 2 trial of BHV-3500 intranasal migraine drug
Biohaven Pharmaceutical announced the successful completion of a Phase 1 trial of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist and said that the company plans to initiate a Phase 2 efficacy trial in the second quarter of 2019. Biohaven CEO Vlad Coric said, "We are excited to report that intranasal administration of BHV-3500 in … [Read more...] about Biohaven announces plans for Phase 2 trial of BHV-3500 intranasal migraine drug
Novus Therapeutics announces Phase 2a study of OP0201 intranasal MDI for otitis media
Novus Therapeutics has provided an update on ongoing Phase 1 clinical trials of its OP0201 nasal MDI for the treatment of otitis media and has announced plans for a Phase 2a study in infants and children. The new randomized, double-blind, placebo-controlled Phase 2a trial (C-006), which replaces a planned Phase 1 study in children with otitis media with effusion, … [Read more...] about Novus Therapeutics announces Phase 2a study of OP0201 intranasal MDI for otitis media
Verona Pharma’s RPL554 gets international non-proprietary name “ensifentrine”
According to Verona Pharma, the World Health Organization (WHO) has approved the name “ensifentrine” as the international non-proprietary name for the company’s RPL554 inhaled PDE3/PDE4 inhibitor, which is in development as both an MDI and a DPI for the treatment of respiratory diseases. Verona Pharma CEO Anders Karlsson said, “We are pleased to receive approval … [Read more...] about Verona Pharma’s RPL554 gets international non-proprietary name “ensifentrine”