Takeda shares positive Phase IIIb data; NIA grant for Phase II study on new oral Alzheimer's treatment
→ Takeda says its VARSITY, Phase IIIb study “demonstrated that the gut-selective biologic vedolizumab (Entyvio) was superior to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira) in achieving clinical remission at week 52 in patients with moderately to severely active ulcerative colitis. New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively. A separation between the treatment groups was seen as early as week 6, favoring vedolizumab.”
Results were presented at the 2019 Digestive Disease Week (DDW) annual scientific meeting.
→ After Biogen’s aducanumab Phase III disaster, some developers have begun to steer clear of the amyloid beta field in Alzheimer’s, but it hasn’t discouraged one company. T3D Therapeutics, with its T3D-959 new orally administered treatment for Alzheimer’s, has received a grant that is expected to total $9 million over four years from the NIA. This grant will help fund a Phase II clinical study of the company’s metabolic-focused AD drug treatment.
The company says that the Phase II PIONEER study is expected to initiate patient dosing in early 2020 and says that they expect to enroll up to 252 adults with mild to moderate Alzheimer’s, who will receive one of three different doses of T3D-959 or placebo for 24 weeks.
→ UCB says the FDA has approved its NDA for a new anti-epileptic drug dubbed Nayzilam (midazolam) nasal spray. The company bought the drug a year ago and say this is the first nasal therapy available for seizure clusters.