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Medical

Phase 2 trial of Verona’s MDI formulation of ensifentrine meets primary and secondary endpoints

Verona Pharma reported that a Phase 2 study of 3 dose levels of its MDI formulation of ensifentrine in patients with moderate to severe COPD met all of its primary and secondary endpoints, demonstrating significant improvements in lung function compared to placebo. Improvements in peak FEV1 ranged from 205 mL for a 300 µg dose to 326 mL for a 3000 µg dose. Verona had … [Read more...] about Phase 2 trial of Verona’s MDI formulation of ensifentrine meets primary and secondary endpoints

Noveome partners with Walter Reed Army Institute of Research on preclinical study of intranasal ST266 secretome

Noveome Biotherapeutics has signed a research and development agreement with Walter Reed Army Institute of Research (WRAIR) regarding preclinical studies of an intranasal formulation of Noveome's ST266 secretome, the company said. Under the agreement, WRAIR Branch Chief Deborah Shear will evaluate intranasal ST266 in animal models of traumatic brain injury (TBI), with … [Read more...] about Noveome partners with Walter Reed Army Institute of Research on preclinical study of intranasal ST266 secretome

Ovoca Bio initiates Phase 2 study of BP-101 nasal spray for the restoration of sexual desire in premenopausal women

Ovoca Bio announced that it has initiated a Phase 2 study of its BP-101 intranasal synthetic peptide for the treatment of hypoactive sexual desire disorder (HSDD). The dose ranging study, which will take place in Australia and New Zealand, is expected to enroll 476 premenopausal women who are experiencing distress due to low libido and will evaluate the effects of … [Read more...] about Ovoca Bio initiates Phase 2 study of BP-101 nasal spray for the restoration of sexual desire in premenopausal women

AIM ImmunoTech announces planned Phase 1 study of intranasal Ampligen

AIM ImmunoTech announced that the Centre for Human Drug Research (CHDR) will conduct a Phase 1 study of an intranasal formulation of the company's Ampligen rintatolimod, which the company wants to develop for the treatment of COVID-19. IV Ampligen is currently approved in Argentina for the treatment of chronic fatigue syndrome, and AIM recently began treating some … [Read more...] about AIM ImmunoTech announces planned Phase 1 study of intranasal Ampligen

Study demonstrates that patients can switch successfully from Tyvaso inhalation solution to Tyvaso DPI

United Therapeutics announced that its BREEZE study has demonstrated that patients with pulmonary arterial hypertension (PAH) who use Tyvaso treprostinil inhalation solution can safely switch to the Tyvaso treprostinil DPI. The company also announced that a PK study in healthy volunteers showed that the treprostinil exposure from Tyvaso DPI was comparable to that of … [Read more...] about Study demonstrates that patients can switch successfully from Tyvaso inhalation solution to Tyvaso DPI

First patients dosed in Meissa’s Phase 2 trial of its intranasal vaccine against RSV

Meissa Vaccines said that it has started dosing participants in its Phase 2 trial of MV-012-968 intranasal live attenuated vaccine candidate against respiratory syncytial virus (RSV). MV-012-968 is based on Meissa's AttenuBlock platform, which it says is designed for "creating safe, potent, stable, and cost-effective intranasal vaccines." The Phase 2 virus challenge … [Read more...] about First patients dosed in Meissa’s Phase 2 trial of its intranasal vaccine against RSV

Synairgen initiates Phase 3 trial of inhaled interferon beta-1a in hospitalized COVID-19 patients

Synairgen said that the first patient has been dosed in the Phase 3 SG018 trial of its SNG001 inhaled interferon beta-1a in hospitalized COVID-19 patients, with the SG018 study expected to enroll 610 COVID-19 patients at sites in 20 countries. A Phase 2 study of SNG001 in non-hospitalized patients is also underway, the company said. In July 2020, Synairgen … [Read more...] about Synairgen initiates Phase 3 trial of inhaled interferon beta-1a in hospitalized COVID-19 patients

UC Davis spin out InVixa to develop inhaled statins for the treatment of COVID-19

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

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

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