Galecto has announced that the company's Phase 2b GALACTIC-1 study of GB0139 (formerly TD139) galectin-3 inhibitor DPI for the treatment of idiopathic pulmonary fibrosis (IPF) will discontinue the higher dose (10 mg) arm and will limit enrollment in the lower dose (3 mg) arm to patients who are not taking nintedanib or pirfenidone. The company said that it is making … [Read more...] about Phase 2b study of Galecto’s galectin-3 DPI for IPF to discontinue higher dose arm
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FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Meissa Vaccines announced that the FDA has cleared the company's IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND meeting with the agency regarding an intranasal vaccine against SARS-CoV-2 in June 2020. The Phase 1 study is expected to enroll 130 healthy … [Read more...] about FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Positive Phase 1 results for inhaled Ampion for COVID-19
Ampio Pharmaceuticals said that preliminary results from its AP-014 Phase 1 clinical trial of inhaled Ampion for the treatment of COVID-19 demonstrate a significant reduction in all-cause mortality and shorter hospital stays for patients receiving Ampion compared to standard of care alone. Ampio initiated the Phase 1 trial in October 2020. Based on the initial … [Read more...] about Positive Phase 1 results for inhaled Ampion for COVID-19
SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19
Canadian biotech SaNOtize said that a Phase 2 trial of its nitric oxide nasal spray (NONS) in COVID-19 patients demonstrated that the nasal spray reduced viral load by about 95% within 24 hours post dose and by more than 99% within 72 hours. In addition, clearance of the SARS-CoV-2 virus was 16 times faster for patients using NONS than for those given a placebo. Based … [Read more...] about SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19
TFF Pharmaceuticals announces agreements for feasibility studies of mRNA vaccine candidate and aviptadil
TFF Pharmaceuticals has announced agreements for feasibility studies with vaccine developer GreenLight Biosciences and with NeuroRx. TFF is performing studies to determine if dry powder formulations of GreenLight's mRNA COVID-19 vaccine candidate and NeuroRx's Zyesami aviptadil can be successfully created using TFF's thin film freezing technology. According to … [Read more...] about TFF Pharmaceuticals announces agreements for feasibility studies of mRNA vaccine candidate and aviptadil
The Gates Medical Research Institute to develop dry powder lung surfactant for the treatment of RDS in premature infants
The Lundquist Institute for Biomedical Innovation (TLI, formerly LABioMed) has licensed a dry powder synthetic lung surfactant formulation to The Bill & Melinda Gates Medical Research Institute (Gates MRI), TLI said. Gates MRI plans to develop the inhalation powder for the treatment of respiratory distress syndrome (RDS) in premature infants in low- and … [Read more...] about The Gates Medical Research Institute to develop dry powder lung surfactant for the treatment of RDS in premature infants
AIM ImmunoTech initiates Phase 1 trial of intranasal Ampligen for COVID-19
AIM ImmunoTech announced that that the first subjects have been dosed in a Phase 1 safety study of an intranasal formulation of the company’s Ampligen rintatolimod, which the company is developing for the prevention and/or treatment of COVID-19. AIM announced plans for the study in January 2021. According to AIM, in vitro modeling has demonstrated that "clinically … [Read more...] about AIM ImmunoTech initiates Phase 1 trial of intranasal Ampligen for COVID-19
Pneumagen says preclinical study demonstrates the potential of Neumifil for COVID-19
According to Pneumagen, its Neumifil carbohydrate binding module (mCBM), which it is developing as a nasal spray for the prevention and treatment of respiratory infections, significantly reduced symptoms and weight loss in a hamster model of COVID-19. Researchers also found that Neumifill demonstrated high binding affinity for the ACE2 receptor and for the SARS-CoV-2 … [Read more...] about Pneumagen says preclinical study demonstrates the potential of Neumifil for COVID-19
Pulmatrix announces development plans for PUR3100 inhaled dry powder DHE for the treatment of migraine
Pulmatrix has announced plans for clinical development of PUR3100, an iSPERSE dry powder formulation of dihydroergotamine (DHE) for the treatment of migraine, after a PK study in dogs showed exposure kinetics similar to those of the Levadex (MAP0004, Semprana) DHE MDI. The company also provided updates on its development programs for Pulmazole and PUR1800 and said … [Read more...] about Pulmatrix announces development plans for PUR3100 inhaled dry powder DHE for the treatment of migraine
FDA clears Sorrento’s IND for Phase 1 trial of STI-2099 intranasal antibody against COVID-19
Sorrento Therapeutics said that the FDA has cleared its IND for a Phase 1 study of STI-2099 intranasal neutralizing antibody (CoviDrops) in healthy volunteers and in patients with mild COVID-19. The company said that it plans to study STI-2099 by itself or combined with an IV formulation of the antibody. In October 2020, Sorrento announced that STI-2099 reduced the … [Read more...] about FDA clears Sorrento’s IND for Phase 1 trial of STI-2099 intranasal antibody against COVID-19