Aerami Therapeutics said that it has initiated dosing in a Phase 1 clinical trial of its AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH). According to the study description on clinicaltrials.gov, the SAD/MAD trial is expected to enroll 78 healthy volunteers and is expected to evaluate doses of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg in … [Read more...] about Aerami initiates Phase 1 trial of AER-901 inhaled imatinib for PAH
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Positive results from Phase 1 trial of Nasus Pharma’s intranasal dry powder epinephrine
Nasus Pharma said that a Phase 1 PK study of its FMXIN002 intranasal dry powder epinephrine demonstrated that FMXIN002 could produce a maximum plasma level comparable to that of epinephrine delivered via EpiPen and reached that level significantly faster than the injection. The open-label SAD study enrolled 12 volunteers and compared 1.6 and 3.2 mg doses of FMXIN002 … [Read more...] about Positive results from Phase 1 trial of Nasus Pharma’s intranasal dry powder epinephrine
Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint
Theravance Biopharma said that a Phase 2 study of its inhaled nezulcitinib (TD-0903) pan-JAK inhibitor in hospitalized COVID-19 patients failed to meet its primary endpoint of respiratory failure free days at Day 28. The study did demonstrate some improvement in all-cause mortality, and in patients with C-reactive protein levels below 150 mg/L, nezulcitinib … [Read more...] about Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint
Oyster Point initiates Phase 2 trial of OC-01 varenicline nasal spray for neurotrophic keratopathy
Oyster Point Pharma has announced the initiation of the OLYMPIA Phase 2 clinical trial of its OC-01 varenicline nasal spray for the treatment of neurotrophic keratopathy. The company's NDA for OC-01 for the treatment of dry eye disease is currently under review by the FDA. The OLYMPIA study is expected to enroll approximately 100 patients with Stage 1 neurotrophic … [Read more...] about Oyster Point initiates Phase 2 trial of OC-01 varenicline nasal spray for neurotrophic keratopathy
ENA Respiratory gets AU$32 million for development of INNA-051 antiviral nasal spray for COVID-19
ENA Respiratory said that it has raised up to AU$32 million for development of its INNA-051 pegylated TLR2/6 agonist nasal spray for the prevention of respiratory viruses, including COVID-19, and plans to initiate a Phase 1 study of the nasal spray within a few weeks. In September 2020, the company announced a preclinical study demonstrated that INNA-051 reduced … [Read more...] about ENA Respiratory gets AU$32 million for development of INNA-051 antiviral nasal spray for COVID-19
Noveome announces Phase 1 results from study of intranasal ST266 in patients at risk of glaucoma
Noveome Biotherapeutics said that a Phase 1 safety study of its intranasal ST266 secretome in glaucoma suspect patients demonstrated no serious adverse events at doses up to 400 µL per day over 28 days. The open label study evaluated single doses of 200 µL daily for 14 days, two doses of 200 µL daily for 14 days, and two doses of 200 µL daily for 28 days. Noveome … [Read more...] about Noveome announces Phase 1 results from study of intranasal ST266 in patients at risk of glaucoma
AIM Immunotech extends deal with Smoore related to development of inhaled Ampligen
AIM ImmunoTech said that it has extended a 2020 agreement with Shenzhen Smoore Technology related to development of an inhaled version of its Ampligen rintatolimod for the treatment of COVID-19. The agreement with Smoore is for the use of a Smoore-designed "personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA." According to … [Read more...] about AIM Immunotech extends deal with Smoore related to development of inhaled Ampligen
EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients
The EMA’s COVID-19 task force has said "that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19." In addition, the task force said that "it could not exclude the possibility of harm from the use of inhaled corticosteroids in patients with COVID-19 who have normal levels of oxygen." Evidence cited by the … [Read more...] about EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients
Inhalon Biopharma gets US Army contract for development of inhaled antibody for the treatment of COVID-19
According to North Carolina-based startup Inhalon Biopharma, the US Army Medical Research & Development Command (USAMRDC) has awarded the company a contract worth $7 million for a Phase 1/2a study of its IN-006 inhaled neutralizing monoclonal antibody for the treatment of COVID-19 in an outpatient setting. The company expects topline results to be available in … [Read more...] about Inhalon Biopharma gets US Army contract for development of inhaled antibody for the treatment of COVID-19
Inhalation Sciences gets approval for PreciseInhale trial
The Swedish Medical Product Agency (Läkemedelsverket) has approved an application from Inhalation Sciences (ISAB) for a clinical trial of its PreciseInhale aerosol generation system, the company said. ISAB expects to initiate the trial in June 2021 and to complete the study by the end of the year. Inhalation Sciences first announced its intentions to validate … [Read more...] about Inhalation Sciences gets approval for PreciseInhale trial