A new spin out from the University of California, Davis called InVixa announced that it has acquired the rights to UC Davis intellectual property related to delivery of statins to the lung for the treatment of viral respiratory infections, including COVID-19. InVixa said that it expects to select a lead candidate following pre-clinical studies early this year and … [Read more...] about UC Davis spin out InVixa to develop inhaled statins for the treatment of COVID-19
Medical
Phase 2 study of Seelos’s intranasal racemic ketamine for suicidal ideation gets underway
Seelos Therapeutics announced that the first patients have been dosed in a Phase 2 study of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. In November 2019, Seelos announced that it had been granted Fast Track designation for SLS-002 for this indication, and in January 2020, … [Read more...] about Phase 2 study of Seelos’s intranasal racemic ketamine for suicidal ideation gets underway
Receptor Life Sciences announces completion of pre-IND meeting for its CBD DPI for the treatment of panic attacks
Receptor Life Sciences (RLS) said that a pre-IND meeting with the FDA "resulted in clear guidance on the regulatory requirements" for development of the company's RLS103 dry powder cannabidiol (CBD) for the treatment of panic attacks. The company is pursuing the 505(b)(2) pathway for approval of RLS103. In 2016, MannKind Corporation announced that it had licensed … [Read more...] about Receptor Life Sciences announces completion of pre-IND meeting for its CBD DPI for the treatment of panic attacks
Phase 1/2 trial of inhaled phage therapy for the treatment of P. aeruginosa infections in CF patients gets underway
According to Felix Biotechnology, Yale University researchers have initiated a Phase 1/2 trial of Felix's YPT-01 nebulized phage therapy for the treatment of chronic P. aeruginosa infections in cystic fibrosis patients. YPT-01 was initially formulated at Yale and licensed to Felix, a start-up founded by Yale Faculty. Felix recently signed a deal with TFF … [Read more...] about Phase 1/2 trial of inhaled phage therapy for the treatment of P. aeruginosa infections in CF patients gets underway
Insmed initiates Phase 3b clinical trial of Arikayce inhalation suspension for the treatment of NTM caused by MAC
Insmed announced that the first patient has been dosed in a Phase 3b trial of its Arikayce amikacin liposome inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). Arikayce is delivered via the PARI Lamira nebulizer system. The FDA approved Arikayce for the treatment of NTM lung … [Read more...] about Insmed initiates Phase 3b clinical trial of Arikayce inhalation suspension for the treatment of NTM caused by MAC
Arcturus Therapeutics to develop inhaled CFTR mRNA therapy for CF
California-based Arcturus Therapeutics announced that it will develop its ARCT-032 aerosolized CFTR mRNA formulation for the treatment of cystic fibrosis. According to Arcturus, preclinical studies of ARCT-032, which is based on the company's LUNAR (lipid-enabled and unlocked nucleomonomer agent modified RNA) technology, have demonstrated that the inhaled therapy has … [Read more...] about Arcturus Therapeutics to develop inhaled CFTR mRNA therapy for CF
Polyphor to initiate Phase 1 trial of inhaled murepavadin
According to Polyphor, the UK's MHRA has authorized a Phase 1 study of the company's murepavadin inhalation solution, which the company is developing for the treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients. Initiation of the study, which is partially funded by the European Innovative Medicines Initiative, is expected within weeks. The … [Read more...] about Polyphor to initiate Phase 1 trial of inhaled murepavadin
Tonix to develop intranasal oxytocin for the treatment of insulin resistance and obesity
Several months after acquiring the rights to TNX-1900 oxytocin nasal spray for the treatment of migraine headaches from Trigemina, Tonix Pharmaceuticals announced that it has acquired an exclusive license to technology from the University of Geneva for the use of oxytocin to treat insulin resistance and related conditions such as obesity. The company has not yet … [Read more...] about Tonix to develop intranasal oxytocin for the treatment of insulin resistance and obesity
Novan selects Catalent for development of intranasal berdazimer sodium
Catalent will supply development services for an intranasal formulation of Novan's berdazimer sodium for COVID-19, the companies said. Berdazimer sodium is a nitric oxide-releasing polymer based on Novan's Nitricil platform, and the company is developing topical gel formulations for the treatment of viral dermatological infections, including molluscum and genital … [Read more...] about Novan selects Catalent for development of intranasal berdazimer sodium
PrEP Biopharm to initiate trial of PrEP-001 intranasal Poly I:C against respiratory viruses
Johnson & Johnson spinout PrEP Biopharm said that it is ready to initiate a real-world trial of its PrEP-001 intranasal "viral RNA surrogate" against common respiratory viruses after the successful completion of a toxicology study in dogs. The trial is designed to evaluate the efficacy PrEP-001, an intranasal dry powder formulation of polyinosinic:polycytidylic … [Read more...] about PrEP Biopharm to initiate trial of PrEP-001 intranasal Poly I:C against respiratory viruses