According to Avalyn Pharma, Phase 1 trials of AP02 inhaled nintedanib demonstrated that all dose levels of the nebulized formulation were safe and well tolerated and that the company now plans to advance AP02 into a Phase 2 trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn said that it will present top-line data from the Phase 1 studies at the … [Read more...] about Avalyn announces plans to advance AP02 inhaled nintedanib into Phase 2 trial in IPF patients
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Lovaltech gets go-ahead for MUCOBOOST Phase 1 trial of LVT-001 intranasal vaccine against COVID-19
French biotech Lovaltech announced that the Agence nationale de sécurité du médicament (ANSM) and the Comité de Protection des Personnes (CPP) have authorized the company's planned MUCOBOOST Phase 1 trial of LVT-001 nasal vaccine against COVID-19, and the trial is expected to start by the end of April 2025. The study, which is expected to enroll 36 adults aged 18-55, … [Read more...] about Lovaltech gets go-ahead for MUCOBOOST Phase 1 trial of LVT-001 intranasal vaccine against COVID-19
McMaster University initiates the AeroVax Phase 2 trial of its inhaled COVID-19 vaccine
McMaster University has announced the initiation of the AeroVax Phase 2 trial of its ChAd-triCoV/Mac inhaled vaccine against SARS-CoV-2. According to McMaster, the Canadian Institutes of Health Research has provided $8 million to support the study, which will be led by researchers from the university's Michael G. DeGroote Institute for Infectious Disease Research. … [Read more...] about McMaster University initiates the AeroVax Phase 2 trial of its inhaled COVID-19 vaccine
Oragenics submits application for Phase 2 trial of ONP-002 intranasal neurosteroid powder for TBI
Oragenics announced that it has submitted an Investigator’s Brochure application to Australian authorities seeking the go-ahead for a Phase 2 trial of ONP-002, a dry powder intranasal neurosteroid, for the treatment of mild traumatic brain injury. In 2023, Oragenics acquired ONP-002 from Odyssey Health, which had announced Phase 1 results the previous year. In August … [Read more...] about Oragenics submits application for Phase 2 trial of ONP-002 intranasal neurosteroid powder for TBI
Tiziana submits IND for Phase 2 trial of intranasal foralumab in ALS
Tiziana Life Sciences announced that it has submitted an IND to the FDA seeking approval for a Phase 2 trial of intranasal foralumab in patients with amyotrophic lateral sclerosis. In November 2024, the company announced that it had received a grant from the ALS Association to fund a trial in patients with ALS. According to the company, the planned Phase 2 study would … [Read more...] about Tiziana submits IND for Phase 2 trial of intranasal foralumab in ALS
Boehringer Ingelheim announces initiation of Phase 1/2 trial of BI3720931 inhaled gene therapy for CF
A group comprised of Boehringer Ingelheim, IP Group, the UK Respiratory Gene Therapy Consortium, and CDMO OXB, has announced the initiation of the Phase 1/2 Lenticlair 1 study of BI 3720931, an inhaled lentiviral vector-based gene therapy in adult cystic fibrosis patients who cannot be treated with CFTR modulators. The trial is expected to be completed in 2027. … [Read more...] about Boehringer Ingelheim announces initiation of Phase 1/2 trial of BI3720931 inhaled gene therapy for CF
Kexing Biopharm announces FDA approval of IND for GB05 human interferon α1b inhalation solution
According to Kexing Biopharm, the FDA has approved the company's IND for GB05 human interferon alpha-1b inhalation solution, which the company's subsidiary Shenzhen Kexing plans to advance into clinical development for the treatment of lung infections caused by respiratory syncytial virus in children. In April 2024, Kexing announced the initiation of a Phase 3 trial … [Read more...] about Kexing Biopharm announces FDA approval of IND for GB05 human interferon α1b inhalation solution
Ethris gets $5 million from CEPI for development of spray-dried RNA vaccines for nasal delivery
The Coalition for Epidemic Preparedness Innovations (CEPI) is providing $5 million to inhaled RNA developer Ethris for development of spray-dried RNA vaccines for nasal delivery. Ethris said that it plans to focus initially on a vaccine against influenza once a successful process is established. Within the past few months, CEPI also provided funding to an Abera … [Read more...] about Ethris gets $5 million from CEPI for development of spray-dried RNA vaccines for nasal delivery
AIM ImmunoTech announces planned trial of intranasal Ampligen in combination with FluMist against avian flu
AIM ImmunoTech has announced that it plans to move forward with a trial of intranasal Ampligen rintatolimod as an adjuvant to AstraZeneca's FluMist intranasal flu vaccine for the prevention of avian flu. The company said that it plans to run the trial as a follow-up to a 2012 trial of Ampligen in conjunction with FluMist that was conducted at the University of … [Read more...] about AIM ImmunoTech announces planned trial of intranasal Ampligen in combination with FluMist against avian flu
Flu Lab invests $5 million in ENA Respiratory to support development of INNA-051 intranasal dry powder immune enhancer
According to ENA Respiratory, California-based non-profit organization Flu Lab is providing a $5 million investment to support a Phase 2 proof of concept study of the company's INNA-051 intranasal dry powder TLR2/6 agonist for the treatment of viral respiratory infections. The Phase 2 study will take place in the US and evaluate the safety and efficacy of INNA-051 for … [Read more...] about Flu Lab invests $5 million in ENA Respiratory to support development of INNA-051 intranasal dry powder immune enhancer