Windtree Therapeutics (NSDQ:WINT) reported data today from the 221-patient Phase IIb trial of its aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The Aerosurf trial evaluated aerosolized KL4 surfactant administered to premature infants 28 to 32 weeks gestational age in 2 dose groups with up to 2 repeat doses, compared […]
Clinical Trials
Topical post-herpetic neuralgia treatment fails to meet primary endpoint in Phase II
Teva Pharmaceuticals (NYSE:TEVA) and Xenon Pharmaceuticals (NSDQ:XENE) said this week that the Phase II study of a topical post-herpetic neuralgia treatment did not meet its primary or secondary endpoints. The small-molecule inhibitor, TV-45070, was licensed by Xenon to Teva in December 2012. The Phase II trial enrolled 300 patients and randomized them to receive 4% […]
NY Rep. Collins loses millions on Innate flop
Earlier this year, Rep. Chris Collins’ (R-NY) 16.8% stake in Innate Immunotherapeutics (ASX:IIL) was worth $45.5 million. But since the Australian biotech’s lead drug failed in a 93-patient trial this week, shares in the company dropped to 4¢ apiece and Collins’ holdings are now valued at just $1.5 million. As the company’s largest investor and […]
Dissolvable microneedle patch for flu vaccine succeeds in Phase I
Dissolvable microneedle patches that deliver the flu vaccine could provide a safe and cost-effective alternative to traditional immunization methods, according to the results from a Phase I trial published in The Lancet this week. The study enrolled adults ages 18 to 49 and randomly assigned them to receive a single dose of inactivated flu vaccine via […]
Rhythm, Camurus tout early data on setmelanotide in rare genetic obesity
Camurus (STO:CAMX) and biopharma group Rhythm today released initial results from an ongoing Phase 1A clinical trial examining the pharmacokinetics and tolerability of an extended-release formulation of setmelanotide. The drug formulation uses Camurus’ FluidCrystal injection depot drug delivery technology to deliver Setmelanotide, Rhythm’s novel melanocortin-4 receptor agonist designed to treat genetic disorders of obesity. Initial results […]
Theraclion partner UVA wins FDA nod for combined HIFU, immunotherapy breast cancer trial
Theraclion said yesterday its academic development partner, the University of Virginia, won an FDA nod to launch a study of the combined use of echotherapy high intensity focused ultrasound and immunotherapy drug pembrolizumab for treating patients with breast cancer. The study will examine the combined treatment’s effect on fighting breast cancer tumor cells, the French […]
Semnur touts Phase I/II trial of non-opioid pain-killer
Semnur Pharmaceuticals touted data today from a Phase I/II pharmacokinetic trial of its injectable, non-opioid pain-killer, SP-102. The trial enrolled 12 patients with radicular pain. The trial met its primary endpoint and showed that single epidural injection of SP-102 could provide a sustained analgesic effect for 1 month. The company touted its product, which is […]
Camarus, Braeburn tout Phase II data for long-acting buprenorphine depot
Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals touted data yesterday from a Phase II trial of its long-acting buprenorphine depot. The 47-patient trial found that CAM2038 blocks the effects of opioids and suppresses withdrawal symptoms in adults with opioid use disorder. The in-patient trial included 5 3-day test sessions to evaluate the patients’ response to randomized […]
Nanobiotix seeks to boost cancer care with nanoparticle-radiotherapy combo
Increasingly, pharma and biotech companies are looking towards personalized medicine to guide their portfolios, developing therapies designed to address the needs of individual patient populations. Nanobiotix (EMA:NANO) has chosen to look in the other direction, according to co-founder & CEO Laurent Levy. “What we have done in our company is trying to go for the opposite: […]
Indivior touts late-stage trial for monthly buprenorphine depot
Indivior (LON:INDV) touted data today from its pivotal Phase III trial for RBP-6000, a once-monthly injectable buprenorphine depot for the treatment of adults with opioid use disorder. The 24-week study met its primary and key secondary endpoints for both dosage regimens, according to the company. “The clinical data from our Phase III study also showed […]