Following the failure of the Phase 3 SUMMIT trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine to meet the study's primary endpoints, Satsuma Pharmaceuticals says that the company will not invest in commercialization of the product. In September 2020, the company announced that the Phase 3 EMERGE trial of STS101 failed to meet its … [Read more...] about Phase 3 trial of Satsuma’s STS101 DHE nasal powder for migraine fails to meet primary endpoints
Medical
Blue Lake announces interim data from Phase 1 trial of BLB201 intranasal vaccine against RSV
CyanVac subsidiary Blue Lake Biotechnology has presented interim data from a Phase 1 trial of its BLB201 intranasal vaccine against respiratory syncytial virus (RSV) that demonstrate an increase in serum antibody responses from baseline in just under two thirds of subjects aged 18-59, with viral shedding observed in 21% of this age cohort following vaccination. The … [Read more...] about Blue Lake announces interim data from Phase 1 trial of BLB201 intranasal vaccine against RSV
Meissa announces positive Phase 1c data from a study of its intranasal RSV vaccine in infants and toddlers
Meissa Vaccines is presenting Phase 1c data from a study of its MV-012-968 intranasal live attenuated RSV vaccine candidate in 66 children aged 6-36 months demonstrating that the highest dose of the vaccine evaluated induced an immune response in 89% of RSV-naïve subjects, with a serum neutralizing antibody response induced in 78% of the subjects. According to … [Read more...] about Meissa announces positive Phase 1c data from a study of its intranasal RSV vaccine in infants and toddlers
TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
TFF Pharmaceuticals announced that it has been working with Aptar Pharma on a project to develop dry powder vaccines based on TFF's thin film freezing particle manufacturing platform and Aptar Pharma’s Unidose (UDS) nasal powder delivery device. According to the company, Aptar Pharma presented data from the project at the recent Vaccines Summit 2022 and will present … [Read more...] about TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
Arest announces positive Phase 1 results for APN01 inhaled alunacedase alfa
Apeiron Respiratory Therapies (Arest), a subsidiary of Invios, announced that a Phase 1 SAD/MAD study of its APN01 nebulized alunacedase alfa in 40 healthy subjects met all endpoints. Both Arest and Invios were spun off from the original developer of APN01, Apeiron Biologics, earlier this year. Arest is developing APN01, a soluble recombinant human angiotensin … [Read more...] about Arest announces positive Phase 1 results for APN01 inhaled alunacedase alfa
Renovion initiates Phase 2 trial of ARINA-1 inhaled mucolytic in non-CF bronchiectasis patients
Renovion and the COPD Foundation have announced the initiation of a Phase 2 trial of Renovion's ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid in patients with non-CF bronchiectasis (NCFBE). The COPD Foundation announced in September 2021 that it was partnering with Renovion on development of ARINA-1 for the treatment of COPD and NCFBE. The company is … [Read more...] about Renovion initiates Phase 2 trial of ARINA-1 inhaled mucolytic in non-CF bronchiectasis patients
Pieris Pharmaceuticals initiates Phase 1 trial of its PRS-220 inhaled anticalin
Pieris Pharmaceuticals has announced the initiation of a Phase 1 study of PRS-220, an anticalin inhalation solution that targets connective tissue growth factor (CTGF), which the company is developing for the treatment of fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). In June 2021, Pieris announced that it would develop PRS-220 for IPF and for … [Read more...] about Pieris Pharmaceuticals initiates Phase 1 trial of its PRS-220 inhaled anticalin
FDA grants Fast Track designation to Codagenix’s CodaVax intranasal vaccine against RSV
According to Codagenix, the FDA has granted Fast Track designation to the company's CodaVax-RSV live-attenuated intranasal vaccine candidate against respiratory syncytial virus (RSV). Earlier this year, the FDA cleared an IND for CodaVax-RSV. The company now says that the Phase 1 dose escalation study in children aged 6 months to 5 years is expected to start after the … [Read more...] about FDA grants Fast Track designation to Codagenix’s CodaVax intranasal vaccine against RSV
Phase 3 trial of Codagenix’s CoviLiv intranasal vaccine against COVID-19 gets underway
Codagenix has announced the initiation of a Phase 3 trial of its CoviLiv live-attenuated intranasal vaccine against COVID-19. The trial, which is being conducted in partnership with the Serum Institute of India, is part of the World Health Organization's Solidarity Trial Vaccines trial. The Phase 3 study is expected to enroll up to 20,000 healthy adults in countries … [Read more...] about Phase 3 trial of Codagenix’s CoviLiv intranasal vaccine against COVID-19 gets underway
Covis announces positive results from Phase 3 trial of Duaklir and Eklira in Asia
According to Covis Pharma, the Phase 3 AVANT trial of Duaklir aclidinium bromide / formoterol and Eklira (Tudorza) aclidinium bromide DPIs demonstrated statistically significant change in FEV1 from baseline one hour post dose for Duaklir vs Eklira alone and vs formoterol alone, as well as for Eklira vs placebo. Covis acquired global rights to Duaklir and Eklira from … [Read more...] about Covis announces positive results from Phase 3 trial of Duaklir and Eklira in Asia