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
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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
Kenox Pharmaceuticals adds small scale GMP capability for OINDPs
OINDP specialist contract developer Kenox Pharmaceuticals announced that it has added a clean room for small scale manufacturing of non-sterile nasal sprays and dry powders for use in pre-clinical development. The company, which is located in Princeton, NJ, USA, said that it is also in the process of adding Phase 1 and 2 clinical scale GMP manufacturing capabilities … [Read more...] about Kenox Pharmaceuticals adds small scale GMP capability for OINDPs
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
Copley Scientific introduces new Powder Testing Workstation PTW and Powder Testing Assistant PTA 100i
OINDP testing specialists Copley Scientific have announced the launch of the new Powder Testing Workstation PTW for flowability testing as well as the Powder Testing Assistant PTA 100i. The customizable PTW system allows the user to select various modules for angle of repose, flow through an orifice, and bulk density testing of dry powders. The PTA 100i offers … [Read more...] about Copley Scientific introduces new Powder Testing Workstation PTW and Powder Testing Assistant PTA 100i
Beckley announces results of Phase 2a trial of BPL-003 intranasal synthetic 5-MeO-DMT in alcohol use disorder
Beckley Psytech announced that a Phase 2a study of BPL-003 intranasal synthetic 5-MeO-DMT in people with alcohol use disorder demonstrated "meaningful and sustained reductions in alcohol use" for as long as 3 months post dose, with no serious or severe adverse events. The study, which was primarily designed to evaluate safety, enrolled 12 subjects with … [Read more...] about Beckley announces results of Phase 2a trial of BPL-003 intranasal synthetic 5-MeO-DMT in alcohol use disorder
FDA clears IND for a Phase 1 trial of Ocugen’s OCU500 COVID-19 vaccine via inhalation and nasal administration
Ocugen, Inc. announced that the FDA has cleared an IND for a Phase 1 trial of OCU500 vaccine for the prevention of COVID-19, which the company licensed from Washington University in St. Louis in 2022. The trial, which will evaluate inhaled and intranasal administration of the vaccine, will be conducted by the NIH's National Institute of Allergy and Infectious … [Read more...] about FDA clears IND for a Phase 1 trial of Ocugen’s OCU500 COVID-19 vaccine via inhalation and nasal administration
Corstasis says that the FDA has accepted its NDA for RSQ-777 bumetanide nasal spray for the treatment of edema
Nevada-based Corstasis Therapeutics announced that the FDA has accepted the company's NDA for RSQ-777 bumetanide nasal spray, a diuretic for the treatment of edema associated with congestive heart failure, kidney disease, and liver disease. The agency assigned a PDUFA target date of September 14, 2025. Corstasis CEO Benjamin Esque commented, “We are pleased … [Read more...] about Corstasis says that the FDA has accepted its NDA for RSQ-777 bumetanide nasal spray for the treatment of edema
Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial
North Carolina-based Belhaven Biopharma announced that it has closed a funding round that raised $11 million for continued development of the company's Nasdepi intranasal dry powder epinephrine for the treatment of anaphylaxis. The company said that the funds will support the completion of clinical development and preparations for an NDA submission. Belhaven also … [Read more...] about Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial