Medical

Canadian Biotech Immune Biosolutions said it has initiated a Phase 1 clinical trial of its IBIO123 inhaled antibody therapy, which it is developing for the treatment of COVID-19. According to the company, the trial is being conducted in South Africa and will evaluate IBIO123 versus placebo in patients with symptomatic COVID-19. Earlier this year, the Canadian … [Read more...] about Immune Biosolutions initiates Phase 1 trial of IBIO123 inhaled antibody therapy

Inhalon Biopharma and Celltrion have initiated a Phase 1 study of IN-006 inhaled regdanvimab, Inhalon said. The study is funded in part by a US Army contract worth $7 million.  In July 2021, Inhalon and Celltrion announced that they had partnered to develop the nebulized "muco-trapping" formulation of regdanvimab for the treatment of COVID-19. Celltrion's intravenous … [Read more...] about Phase 1 trial of IN-006 inhaled regdanvimab gets underway

The American Academy of Pediatrics (AAP) has issued a clinical report highlighting serious adverse events related to off-label use of OTC oxymetazoline nasal spray in children before and after surgery, noting that in these situations the drug "may be dosed without attention to the volume administered." The report cites recent cases of young children who suffered … [Read more...] about American Academy of Pediatrics highlights safety concerns related to the use of oxymetazoline nasal spray in pediatric surgery

According to Revelation Biosciences, the company has received clearance from an ethics committee for an Australian Phase 1b allergen challenge study of its REVTx-99 intranasal phosphorylated hexaacylated disaccharide (PHAD) for the treatment of allergic rhinitis and chronic nasal congestion. The trial, called RVL-CLR01, is expected to begin in the fourth quarter of … [Read more...] about Revelation Biosciences announces Phase 1b challenge study of its REVTx-99 intranasal PHAD for allergic rhinitis

MannKind Corporation has announced the initiation of the INHALE-1 study of its Afrezza insulin DPI in type 1 and type 2 diabetes patients aged 4-17. The initial 26-week trial will evaluate Afrezza plus basal insulin versus multiple injections of insulin daily and is expected to enroll approximately 260 patients. Following that portion of the trial, all of the subjects … [Read more...] about MannKind initiates Phase 3 trial of Afrezza inhaled insulin in pediatric patients

Blue Lake Biotechnology and its parent company, University of Georgia spin off CyanVac, have announced the initiation of a Phase 1 trial of their CVXGA1 intranasal vaccine for the prevention of COVID-19. CVXGA1 is based on an attenuated strain of canine parainfluenza virus (PIV5). According to the two companies, the intranasal vaccine has demonstrated efficacy against … [Read more...] about CyanVac and Blue Lake Biotechnology initiate Phase 1 trial of CVXGA1 intranasal vaccine for COVID-19

TFF Pharmaceuticals said that a Phase 1 SAD/MAD study of its tacrolimus inhalation powder, which the company is developing for the prevention of lung transplant rejection, demonstrated that the dry powder formulation can be dosed to achieve lung and blood concentrations of tacrolimus necessary for efficacy without causing kidney toxicity. Based on the Phase 1 results, … [Read more...] about Positive Phase 1 results for TFF’s inhaled tacrolimus

According to Codagenix, a Phase 1 dose escalation trial of its COVI-VAC intranasal vaccine against COVID-19 in healthy adults has demonstrated "promising safety and immunogenicity results." Codagenix and Serum Institute of India initiated the Phase 1 trial in December 2020. Based on the Phase 1 data, the company said that it plans to advance COVI-VAC into Phase 2/3 … [Read more...] about Codagenix says it plans to advance COVI-VAC nasal vaccine to Phase 2/3 based on positive Phase 1 topline results

Pulmotect has announced topline results from one of two Phase 2 trials of its PUL-042 immunostimulant inhalation solution demonstrating that PUL-042 therapy significantly reduced the time to respiratory symptom improvement in early-stage COVID-19 patients. The company announced its plans to initiate the two trials in May 2020 and later announced that the US Department … [Read more...] about Positive Phase 2 results for Pulmotect’s PUL-042 inhaled immunostimulant against COVID-19