TFF Pharmaceuticals said that in vitro testing has confirmed the efficacy of a monoclonal antibody against Ebolavirus Zaire and a recombinant vesicular stomatitis virus (rVSV) vaccine candidate against Venezuelan equine encephalitis virus formulated using the company's thin film freezing technology. According to TFF, the in vitro studies demonstrated that both the … [Read more...] about TFF Pharmaceuticals says it has formulated a dry powder mAb against Ebola and vaccine against equine encephalitis
Medical
Insmed says Phase 1 study of treprostinil palmitil inhalation powder supports once-daily dosing
Insmed Incorporated has announced data from a Phase 1 study of its treprostinil palmitil inhalation powder (TPIP) in healthy volunteers demonstrated that TPIP was generally safe and well tolerated and had a lower Cmax and longer half-life than Tyvaso. The study enrolled 42 subjects and evaluated doses as high as 225 µg for a repeated dose and 675 µg for a single … [Read more...] about Insmed says Phase 1 study of treprostinil palmitil inhalation powder supports once-daily dosing
CEBINA partners with Ursapharm Arzneimittel to develop azelastine nasal spray for the treatment of COVID-19
The Central European Biotech Incubator and Accelerator (CEBINA) has announced a partnership with Ursapharm Arzneimittel to repurpose Ursapharm's Pollival azelastine nasal spray for the treatment of COVID-19. In July 2020, CEBINA announced that it had filed a patent application for the use of azelastine to treat COVID-19 and that it was looking for partners … [Read more...] about CEBINA partners with Ursapharm Arzneimittel to develop azelastine nasal spray for the treatment of COVID-19
FDA clears Altimmune’s IND for AdCOVID intranasal vaccine
According to Altimmune, the FDA has now cleared the company’s IND for a Phase 1 trial of its AdCOVID intranasal vaccine candidate, and enrollment in the trial is expected to begin within a week. Altimmune initially submitted the IND in November 2020, and the FDA placed a clinical hold on the application in December 2020 citing the need for changes to the protocols … [Read more...] about FDA clears Altimmune’s IND for AdCOVID intranasal vaccine
Study finds that inhaled budesonide can reduce severity of and speed recovery from COVID-19
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 initates Phase 2/3 trial of nebulized Zyesami aviptadil for the treatment of 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
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