According to Tiziana Life Sciences, The ALS Association will award a Lawrence & Isabel Barnett Drug Development Program Grant to the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s Hospital (BWH) for a preclinical study of Tiziana's intranasal foralumab anti-CD3 monoclonal antibody. The company said that researchers at BWH will evaluate the … [Read more...] about ALS Association to fund preclinical study of intranasal foralumab
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Bryn Pharma says results from a pivotal study of Utuly epinephrine nasal spray are encouraging
Bryn Pharma said that it has completed a pivotal study of its Utuly (BRYN-NDS1C) epinephrine nasal spray comparing PK/PD profiles of Utuly to a 0.3 mg dose of epinephrine delivered by autoinjector. According to the company's web site, Bryn is pursuing the 505(b)(2) NDA pathway with Mylan's EpiPen as the reference listed drug. In 2020, Bryn announced that it had raised … [Read more...] about Bryn Pharma says results from a pivotal study of Utuly epinephrine nasal spray are encouraging
Vistagen to continue Phase 3 PALISADE-2 trial of PH94B nasal spray
Vistagen Therapeutics has announced that it will restart the Phase 3 PALISADE-2 trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder (SAD), which the company had paused after the PALISADE-1 trial failed to meet its primary endpoint. According to Vistagen, an independent interim analysis of unblinded data from 140 subjects from … [Read more...] about Vistagen to continue Phase 3 PALISADE-2 trial of PH94B nasal spray
FluGen announces progress in age de-escalating trial of M2SR intranasal flu vaccine in children
FluGen has announced that a Phase 1b age de-escalation clinical trial of its M2SR intranasal live virus flu vaccine has completed enrollment of the first cohort, which includes children aged 9-17. The study will subsequently evaluate the monovalent Singapore 2016 H3N2 M2SR influenza A vaccine in a cohort of children aged 2-8 and then in children aged 6-23 months, with … [Read more...] about FluGen announces progress in age de-escalating trial of M2SR intranasal flu vaccine in children
Positive Phase 1 results for MannKind’s clofazimine inhalation suspension
MannKind Corporation announced today that a Phase 1 study of MNKD-101 clofazimine demonstrated that the inhalation suspension was well tolerated at doses up to 90 mg/day over 7 days and identified no safety issues. The company is developing MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung disease. According to MannKind, the FDA has granted both … [Read more...] about Positive Phase 1 results for MannKind’s clofazimine inhalation suspension
Hoth Therapeutics says that its HT-004 inhaled antisense oligonucleotide reduced lung inflammation in a mouse model
Hoth Therapeutics said that a preclinical study conducted at North Carolina State University demonstrated that the company's HT-004 inhaled antisense oligonucleotide significantly reduced lung inflammation in mice following an ovalalbumin challenge. According to Hoth, HT-004 works "to eliminate cell surface high-affinity IgE receptor (FceRI) expression and function on … [Read more...] about Hoth Therapeutics says that its HT-004 inhaled antisense oligonucleotide reduced lung inflammation in a mouse model
Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China
According to Nuance Pharma, the Chinese Center for Drug Evaluation has approved the company's IND, allowing for a Phase 3 trial of nebulized ensifentrine, a PDE3/PDE4 inhibitor for the treatment of COPD, in China. The IND also grants approval for a Phase 1 PK study in healthy volunteers that the company plans to conduct in China. Nuance acquired the Chinese rights to … [Read more...] about Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China
NIH announces availability of licensing for IP related to nebulized thrombin inhibitors for the treatment of SARS-CoV-2-induced lung fibrosis
The US National Institutes of Health (NIH) has published a notice in the Federal Register regarding the availability of intellectual property related to the use of inhaled thrombin inhibitors for the treatment of lung fibrosis caused by SARS-CoV-2 infection. The notice says that the technology "is available for licensing to achieve expeditious commercialization of … [Read more...] about NIH announces availability of licensing for IP related to nebulized thrombin inhibitors for the treatment of SARS-CoV-2-induced lung fibrosis
Pneumagen initiates Phase 2 challenge study of Neumifil nasal spray against flu
Pneumagen announced the initiation of a Phase 2 challenge study of its Neumifil multivalent carbohydrate binding module (mCBM) nasal spray, which is the company is developing as a universal treatment for influenza, RSV, and COVID-19. The Phase 2 trial is expected to enroll up to 100 subjects who will receive one of two dose levels of Neumifil or a placebo nasal spray … [Read more...] about Pneumagen initiates Phase 2 challenge study of Neumifil nasal spray against flu
Positive Phase 3 results for Bharat Biotech’s BBV154 intranasal COVID-19 vaccine
According to Bharat Biotech, two recently completed Phase 3 trials of its BBV154 intranasal COVID-19 vaccine demonstrated the safety and tolerability of the recombinant replication-deficient adenovirus vectored vaccine and as well as its ability to elicit an immune response. One of the trials enrolled approximately 3100 subjects who received either two doses of BBV154 … [Read more...] about Positive Phase 3 results for Bharat Biotech’s BBV154 intranasal COVID-19 vaccine