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Larger of two doses of the NGF inhibitor hit two efficacy endpoints, but the rate of joint health outcomes on a composite measure was higher than control by a statistically significant margin.
After disappointing top-line Phase II data in diabetic peripheral neuropathy with NYX-2925, Aptinyx says the full dataset shows significance across endpoints in patients four years or more past diagnosis; a second Phase II study in this subgroup is planned.
Gilead Raday, chief operating officer of RedHill Biopharma, talks to Lucie Ellis, executive editor of In Vivo, about recently published late-stage data and next steps for its antibiotic asset, Talicia (RHB-105), for the treatment of Helicobacter pylori infection.
A 3 May meeting with the FDA is likely to be crucial for the future commercialization strategy for the biotech’s precision-targeted antibacterial.
Biotech thinks its PPAR delta agonist will prove much more potent than Genfit’s elafibranor from the same class and will offer a better tolerability profile than Intercept’s OCA.
Non-alcoholic steatohepatitis (NASH) was a focal point of EASL’s conference. Madrigal becomes the fifth company into Phase III in NASH, but Viking’s competing THR agonist is progressing also.
India’s new clinical trial regulations could revive sponsor interest in the country, but some norms around local Phase III trial waivers appear open to interpretation and could potentially weigh down momentum.
Italy-based Cassiopea says “very positive results” from Breezula's 12-month Phase II alopecia trial support progressing it to Phase III, particularly given the clean safety profile.
Pfizer has high hopes for ketohexokinase inhibition and other fat-reducing mechanisms in NASH. Data from a small study reported at EASL also suggest its KHK inhibitor could have utility in diabetes.
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