Pneumagen announced that a Phase 2 challenge study Neumifil multivalent carbohydrate binding module (mCBM) nasal spray against influenza met its primary endpoints, demonstrating statistically significant reductions in the rate of infection and in symptom severity compared to placebo. The initiation of the challenge study was announced in August 2022. The company … [Read more...] about Pneumagen says Phase 2 challenge study of Neumifil antiviral nasal spray against influenza met primary and secondary endpoints
Medical
FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing "Insufficient information to assess risks to human subjects." The company said that it is waiting to learn more details from the FDA about the reasons for the clinical … [Read more...] about FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
CF Foundation to provide an additional $9 million for development of Arcturus’ ARCT-032 inhaled mRNA therapy
The Cystic Fibrosis Foundation announced that it has agreed to provide an additional $9 million in funding for development of Arcturus Therapeutics' ARCT-032 inhaled mRNA therapy for the treatment of CF. The CF Foundation said that it has already provided $15.6 million for development of ARCT-032, which is based on Arcturus' LUNAR lipid nanoparticle delivery platform. … [Read more...] about CF Foundation to provide an additional $9 million for development of Arcturus’ ARCT-032 inhaled mRNA therapy
Krystal Biotech announces plans for Phase 1 trial of KB408 inhaled gene therapy for the treatment of AAT
Krystal Biotech said that the FDA has cleared an IND for KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin deficiency, and the company said that it plans to initiate a Phase 1 trial in early 2024. According to Krystal, the study will evaluate 3 ascending doses of KB408 in adult patients with AAT deficiency who have a PI*ZZ genotype. KB408 is … [Read more...] about Krystal Biotech announces plans for Phase 1 trial of KB408 inhaled gene therapy for the treatment of AAT
Seelos says 2nd part of Phase 2 study of SLS-002 intranasal racemic ketamine for suicidal ideation and behavior demonstrated improvement in symptoms
Seelos Therapeutics asserts that the second part of its Phase 2 trial of SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in major depressive disorder would have met its primary endpoint if the study had been able to reach full enrollment. According to the company, the trial enrolled only 147 out of an anticipated 220 … [Read more...] about Seelos says 2nd part of Phase 2 study of SLS-002 intranasal racemic ketamine for suicidal ideation and behavior demonstrated improvement in symptoms
Insmed announces results of the Phase 3 ARISE study of Arikayce for NTM lung infections caused by MAC
Insmed announced that the Phase 3 ARISE study of Arikayce amikacin liposome inhalation suspension demonstrated the effectiveness of the QOL-B questionnaire for patient-reported outcomes. The ARISE study of Arikayce in patients with nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) was initiated in December 2020 with the … [Read more...] about Insmed announces results of the Phase 3 ARISE study of Arikayce for NTM lung infections caused by MAC
PureIMS announces planned Phase 1 trial of Levodopa Cyclops
PureIMS has announced that it intends to initiate a dose-finding study of its Levodopa Cyclops DPI titled "A pilot open-label, randomized, crossover, comparative bioavailability study of levodopa administered via Levodopa Cyclops (test product) relative to Inbrija (reference product) in healthy adult subjects" by the end of this year. In April 2023, PureIMS announced … [Read more...] about PureIMS announces planned Phase 1 trial of Levodopa Cyclops
Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Immune Biosolutions has announced the publication of results from Phase 1 and 2 trials of the company's IBIO123 inhaled antibody therapy in patients with COVID-19 in The Lancet Infectious Diseases. Immune Bio announced the initiation of the Phase 1 trial in October 2021. According to the journal article, the Phase 2 study was stopped early because COVID-19 became … [Read more...] about Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Galecto to discontinue development of its GB0139 DPI for the treatment of IPF after Phase 2b trial fails to meet its primary endpoint
Galecto has announced that the Phase 2b GALACTIC-1 of its GB0139 inhaled galectin-3 inhibitor for the treatment of idiopathic pulmonary fibrosis failed to meet its primary endpoint and, as a result, the company will discontinue development of the DPI. GALACTIC-1 was initiated in February 2019. In March 2021, Galecto announced that it was discontinuing the higher dose … [Read more...] about Galecto to discontinue development of its GB0139 DPI for the treatment of IPF after Phase 2b trial fails to meet its primary endpoint
Silo Pharma says it will develop intranasal formulation of SPC-15 ketamine for the treatment of stress disorders
Silo Pharma said that it is planning to develop an intranasal formulation of its SPC-15, which includes "ketamine compositions," for the prevention and treatment of stress disorders, including anxiety and PTSD. The formulation was developed at Columbia University under a sponsored research agreement. According to Silo, US Patent no 11,622,948 ("Biomarkers for Efficacy … [Read more...] about Silo Pharma says it will develop intranasal formulation of SPC-15 ketamine for the treatment of stress disorders