Kither Biotech has announced the initiation of a Phase 1 trial of its KIT2014, an inhaled peptide that the company is developing as a CFTR enhancer for use as an add-on with CFTR modulators for the treatment of cystic fibrosis. The SAD/MAD study is expected to enroll 72 healthy volunteers and will evaluate as many as 6 dose levels of KIT2014 delivered via nebulizer … [Read more...] about Kither Biotech announces initiation of Phase 1 trial of KIT2014 inhaled CFTR enhancer
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Satsuma resubmits its NDA for STS101 DHE nasal powder for migraine
Satsuma Pharmaceuticals announced that it has resubmitted its NDA for STS101 intranasal dry powder dihydroergotamine for the acute treatment of migraine with or without aura. The company initially submitted the NDA in March 2023 even though the Phase 3 SUMMIT trial of STS101 failed to meet its primary endpoints. In January 2024, the FDA issued a CRL to the … [Read more...] about Satsuma resubmits its NDA for STS101 DHE nasal powder for migraine
Polyrizon raises $4.2 million for continued development of its intranasal hydrogels
Intranasal hydrogel maker Polyrizon announced that it has closed a $4.2 million IPO, with a possibility of the total rising to $4.82 million if Aegis Capital exercises an option to purchase additional shares. Polyrizon said that funds from the IPO will be used for development of its hydrogel products for nasal drug delivery, called Capture and Contain (C&C), a … [Read more...] about Polyrizon raises $4.2 million for continued development of its intranasal hydrogels
Sensory Cloud says study of its alkaline hypertonic divalent salt aerosol for chronic cough demonstrated significant reduction in cough frequency
Sensory Cloud has announced the publication of an article in ERJ Open Research presenting data from a study of its SC001 intranasal alkaline hypertonic divalent salt in patients with refractory chronic cough (RCC). The company says it will now advance an orally inhaled formulation, SC0023 alkaline hypertonic divalent salt, into a Phase 2a trial. The study, which … [Read more...] about Sensory Cloud says study of its alkaline hypertonic divalent salt aerosol for chronic cough demonstrated significant reduction in cough frequency
AuraVax gets BARDA contract to test its NanoSTING-002 mucosal adjuvant with Codagenix’s intranasal flu vaccine
AuraVax Therapeutics announced that the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded the company a preclinical research contract to support evaluation of AuraVax's NanoSTING-002 mucosal adjuvant with Codagenix's intranasal live attenuated influenza virus (LAIV). In early 2021, AuraVax announced … [Read more...] about AuraVax gets BARDA contract to test its NanoSTING-002 mucosal adjuvant with Codagenix’s intranasal flu vaccine
Vaxinano raises €6 million for development of intranasal vaccines
French vaccine developer Vaxinano announced that it has raised €6 million to support clinical development of several intranasal vaccine candidates based on the Stellar-NP nanoparticle platform. The company's pipeline includes nasal vaccines against zoonotic diseases and parasites such as leishmaniasis and toxoplasmosis, with the majority of Vaxinano's vaccines … [Read more...] about Vaxinano raises €6 million for development of intranasal vaccines
Agomab raises $89 million for development of candidates including AGMB-447 inhaled ALK5 inhibitor for IPF
Agomab Therapeutics said that it has closed an $89 million Series D financing round that will support development of several candidates, including its AGMB-447 inhaled ALK5 inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF). New investors participating in the round included Sanofi and private equity investor Invus. In December 2023, Agomab … [Read more...] about Agomab raises $89 million for development of candidates including AGMB-447 inhaled ALK5 inhibitor for IPF
Orexo initiates study of OX640 epinephrine nasal powder in patients with allergic rhinitis
Orexo announces the initiation of the OX640-002 trial of OX640 epinephrine nasal powder in people with allergic rhinitis, with results expected in early 2025. The new trial is expected to enroll 30 people with allergic rhinitis and includes a test with a nasal allergen introduced prior to the epinephrine in order to compare the absorption of epinephrine with and … [Read more...] about Orexo initiates study of OX640 epinephrine nasal powder in patients with allergic rhinitis
Joshua Ziel joins Bryn Pharma as CEO
Intranasal epinephrine developer Bryn Pharma announced that former Aerami Therapeutics Chief Operating Officer Joshua Ziel has joined the company as CEO, succeeding Sandy Loreaux. Prior to joining Aerami in 2022, Ziel held management positions at Syneos Health and at advertising agency WPP. According to the company, Loreaux has resigned as CEO due to family matters … [Read more...] about Joshua Ziel joins Bryn Pharma as CEO
DDL 2024 to celebrate 35 years as a leading OINDP conference
The annual Drug Delivery to the Lungs (DDL) conference will mark its 35th anniversary during this year's meeting, which will take place December 11-13 at the Edinburgh International Conference Centre (EICC). Organizers have set a registration deadline of Sunday, November 10 to assist them in finalizing plans for a gala dinner celebrating the 35th anniversary. The … [Read more...] about DDL 2024 to celebrate 35 years as a leading OINDP conference