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
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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
Cyrano announces Phase 1 trial of CYR-064 intranasal theophylline in Parkinson’s disease patients
Cyrano Therapeutics announced the launch of a Phase 1 study of CYR-064 intranasal theophylline in Parkinson's disease patients that is being conducted by David Silvers of Gardens Neurology in Palm Beach, Florida. Cyrano is developing the theophylline nasal spray for the restoration of the sense of smell in patients with reduced or absent sense of smell. In 2023, … [Read more...] about Cyrano announces Phase 1 trial of CYR-064 intranasal theophylline in Parkinson’s disease patients
GH Research says Phase 2b trial of GH001 inhaled mebufotenin met primary endpoint
GH Research announced that a Phase 2b clinical trial of GH001 inhaled synthetic mebufotenin (5-MeO-DMT) in patients with treatment-resistant depression met its primary endpoint, demonstrating a significant reduction in depression symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on Day 8 post dose. All secondary endpoints were also met, the … [Read more...] about GH Research says Phase 2b trial of GH001 inhaled mebufotenin met primary endpoint
Inhalon announces plans for Phase 2a challenge study of IN-002 inhaled antibody against RSV
Inhalon Biopharma announced that it has contracted with hVIVO to conduct a Phase 2a challenge study of nebulized IN-002, an antibody against RSV, now that Inhalon has completed IND-enabling studies. The company said that it expects to initiate the trial of IN-002 in 2026. Inhalon's pipeline of inhaled antibodies also includes IN-003 against metapneumovirus, IN-005 … [Read more...] about Inhalon announces plans for Phase 2a challenge study of IN-002 inhaled antibody against RSV
FDA clears Kinaset’s IND for a Phase 2b trial of KN-002 frevecitinib DPI in patients with asthma
According to Kinaset Therapeutics, the FDA has cleared the company's IND for a Phase 2b trial of its KN-002 frevecitinib dry powder inhaler. The 12-week Phase 2 trial, which will evaluate 3 doses of dry powder frevecitinib in patients with severe asthma that is not adequately controlled by ICS / LABA therapy, is expected to get underway in mid-2025. Kinaset acquired … [Read more...] about FDA clears Kinaset’s IND for a Phase 2b trial of KN-002 frevecitinib DPI in patients with asthma
Ethris announces results of Phase 1 trial of ETH47 intranasal mRNA therapy, plans for Phase 2a trial
German biotech company Ethris announced that a Phase 1 trial of intranasal ETH47 mRNA therapy in healthy volunteers demonstrated "a clear dose-dependent production of IFNλ [interferon lambda] in the nasal lining fluid exceeding predicted therapeutic levels" without any serious or severe adverse events. The company had announced in December 2023 that it was initiating … [Read more...] about Ethris announces results of Phase 1 trial of ETH47 intranasal mRNA therapy, plans for Phase 2a trial
InvisiShield says it is accelerating development of its intranasal antibodies against all influenza A&B, including H5N1 bird flu
InvisiShield Technologies said that it will speed up its H5N1 / Pan-influenza intranasal antibodies development program in response to recent outbreaks of H5N1 avian flu in mammals. The company says that it can move quickly into clinical development because it previously held successful pre-IND meetings with the FDA regarding its IS101 intranasal antibody fusion … [Read more...] about InvisiShield says it is accelerating development of its intranasal antibodies against all influenza A&B, including H5N1 bird flu