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
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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
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
Vistagen initiates Phase 2 repeat dose study of fasendiol nasal spray
Vistagen has announced the initiation of a Phase 2 repeat dose study of fasedienol nasal spray, which the company is developing for the treatment of social anxiety disorder. The Phase 3 PALISADE-3 and PALISADE-4 trials of fasendiol for that indication are ongoing. According to Vistagen, the design of the Phase 2 repeat dose trial is basically the same as the … [Read more...] about Vistagen initiates Phase 2 repeat dose study of fasendiol nasal spray
Orexo says study demonstrated that OX640 intranasal dry powder epinephrine is absorbed faster in subjects with allergic rhinitis
Orexo has announced topline results from its OX640-002 PK/PD study of OX640 intranasal dry powder epinephrine in people with allergic rhinitis. According to the company, the study, which was initiated in October 2024, demonstrated that absorption of OX640 occurred significantly faster in subjects with allergic rhinitis symptoms than in those without rhinitis symptoms. … [Read more...] about Orexo says study demonstrated that OX640 intranasal dry powder epinephrine is absorbed faster in subjects with allergic rhinitis
Rein Therapeutics announces name change, upcoming Phase 2 trial of LTI-03 DPI for IPF
A Texas-based company founded as Lung Therapeutics in 2013 and acquired by Aileron Therapeutics in 2023 announced that it has now changed its name to Rein Therapeutics. Lung Therapeutics spun off TFF Pharmaceuticals in 2018 to develop dry powders based on thin film freezing technology licensed from the University of Texas. Rein Therapeutics President and CEO … [Read more...] about Rein Therapeutics announces name change, upcoming Phase 2 trial of LTI-03 DPI for IPF
GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
Irish biopharm company GH Research said that it has completed inhalation toxicology studies of GH001 inhaled mebufotenin (5-MeO-DMT) necessary to address the FDA's 2023 clinical hold on an IND that the company had submitted for a Phase 1 study of GH001 for the treatment of treatment-resistant depression. In addition, the company announced that 2 Phase 2a proof of … [Read more...] about GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
Aer Therapeutics initiates Phase 2a trial of inhaled fexlamose (AER-01) in COPD patients
Aer Therapeutics has announced the initiation of the AER-01-002 Phase 2a proof-of-concept study of nebulized fexlamose (formerly AER-01) in COPD patients with high mucus plug scores. The trial is expected to enroll 100 patients with moderate-to-severe COPD who will receive daily fexlamose for 28 days. Aer said that it expects to have top-line data available in January … [Read more...] about Aer Therapeutics initiates Phase 2a trial of inhaled fexlamose (AER-01) in COPD patients
Qnovia initiates Phase 1 trial of QN-01 RespiRx inhaled nicotine
Qnovia (formerly Respira Technologies) has announced the initiation of a Phase 1 PK study of its QN-01 inhaled nicotine, which is delivered via the company's RespiRx vibrating mesh inhaler. In October 2024, Qnovia announced that the FDA had cleared an IND for the trial, which is expected to enroll 24 healthy adults who are current cigarette smokers. Results from … [Read more...] about Qnovia initiates Phase 1 trial of QN-01 RespiRx inhaled nicotine
Arcturus announces the initiation of a Phase 2 trial of ARCT-032 inhaled mRNA therapy for cystic fibrosis.
Arcturus Therapeutics announced that it initiated 2 studies in December 2024, one of which is a Phase 2 MAD trial of ARCT-032 inhaled mRNA therapy in cystic fibrosis patients. The company announced in September 2024 that the FDA had cleared its IND for the study, which is expected to enroll 12 adults with CF who do not benefit from CFTR modulators and will evaluate 3 … [Read more...] about Arcturus announces the initiation of a Phase 2 trial of ARCT-032 inhaled mRNA therapy for cystic fibrosis.