Medical

A Phase 2 study of inhaled budesonide for the treatment of COVID-19 found that patients who received 800 mcg twice daily plus standard of care within 7 days after first experiencing symptoms had a 90% reduced risk of urgent medical care or hospital admission compared to patients who did not get inhaled budesonide. The STOIC study enrolled 146 adult patients with early … [Read more...] about Study finds that inhaled budesonide can reduce severity of and speed recovery from COVID-19

NeuroRx announced that it has initiated a Phase 2/3 clinical trial of nebulized Zyesami aviptadil (RLF-100) for the treatment of severe COVID-19. In August 2020, NeuroRx announced that the FDA had cleared an IND for the trial, which is being led by researchers from the University of California Irvine's UCI Health. Principal investigator Richard Lee, Interim Chief … [Read more...] about NeuroRx initates Phase 2/3 trial of nebulized Zyesami aviptadil for the treatment of COVID-19

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

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 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

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

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 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