Welcome to your weekly digest of approaching regulatory and clinical readouts. Intarcia Therapeutics hopes to reward the faith of venture capital backers who have thrown more than $300m at it in the past three years with positive results from the first phase III trial of a GLP-1 implant, ITCA 650.
Salix, meanwhile, is hoping that the FDA will give its blessing next week to the rectal foam version of the ulcerative colitis drug Uceris, a product for proctitis and proctosigmoiditis. And DBV Technologies is in the coming weeks due to hear phase IIb data for its allergy patch, Viaskin Peanut, an event that if positive will likely drive the Paris-based firm's shares higher on speculation of a takeout.
Intarcia Therapeutics: ITCA 650
ITCA 650 is a matchstick-sized osmotic pump secreting the glucagon-like peptide-1 (GLP-1) agonist exenatide, the active ingredient in AstraZeneca’s Byetta and Bydureon. The hope is to deliver a steady state of the drug, which helps to control blood sugar in type 2 diabetes, without side effects like nausea, which can result from peak drug levels in the bloodstream. The device is inserted once a year.
The device’s pivotal Freedom programme includes four trials, the first two of which are due to read out soon. Freedom-1 is a 450-patient trial against placebo measuring change in blood sugar levels in diabetics on a background treatment of metformin or a sulfonyurea. Freedom-1 HBL is an open-label trial in 100 patients with high baseline blood sugar levels.
Intarcia disclosed interim data from HBL at the American Diabetes Association meeting, showing that the device helped 26% of patients achieve blood sugar targets after 13 weeks of treatment.
Demonstrating significantly improved glycaemic control would represent an important validation for Intarcia’s treatment strategy as well as the pump technology. Success would likely encourage pharma and medtech groups to join in partnership or acquisition talks – something the Intacia's VC backers are eagerly awaiting after a $210m financing round in 2012, including $160m in equity, and a second $200m round earlier this year.
Private companies do not normally appear in EP Vantage's event round up, but the amount of investment this one has received and the scope of its studies means that its progress is closely watched.
In the event the Freedom 1 talks do not result in successful dealmaking, Intarcia does not plan to file for regulatory approval until it has data from Freedom-2, which pits ITCA 650 against Januvia in 500 patients. A long-term cardiovascular outcomes trial in 3,000 patients, a routine study in diabetes drugs to satisfy regulators’ safety concerns, is also under way, but will not report until 2018.
Salix: Uceris Rectal Foam
Salix already sells Uceris in the ulcerative colitis setting, as part of a gastrointestinal franchise that includes Apriso and Relistor, and could grow immensely if Xifaxan is approved for irritable bowel syndrome.
Uceris Rectal Foam is intended for use in ulcerative proctitis and proctosigmoiditis, a form of ulcerative colitis that affects the lowest part of the digestive tract. The company says these patients are difficult to treat because the active ingredients of oral drugs like Uceris are insufficiently distributed to the distal part of the colon.
The product has been on the market in Europe since 2006, marketed as Budenofalk by Dr Falk Pharma. It is not expected to be a huge seller in the US – $66m in 2020, according to EvaluatePharma’s forecasts – but it demonstrates that Salix’s strength in gastrointestinal medicine is growing.
A PDUFA action date is set for Monday, September 15.
DBV: Viaskin Peanut
DBV is targeting its electrostatic patch technology specifically at peanut and milk allergies. Viaskin Peanut has so far shown promise in the Arachild phase II study, which tested a 100 microgram dose of peanut protein against placebo in 54 children and adolescents. This included a food challenge test at six, 12 and 18 months, and recorded a tenfold increase in the initial reactive dose.
DBV’s Vipes study, due to read out in late September or early October, is a trial in 221 people allergic to peanuts, testing three different dosages of the Viaskin Peanut patch against placebo – 50, 100 and 250 micrograms. The endpoint is response to a similar food challenge of 1,000mg of peanut proteins, but at 12 months only.
DBV went public in April 2012, and announcement of the Vipes data could be the biggest catalyst in its short life, as interest from big pharma partners could be piqued should they be positive. Analysts from Bryan Garnier give Viaskin Peanut a 40% probability of success based on Arachild, which would rise to 60-80% with success in Vipes. They write that the positive data could drive DBV shares up to €38-49; they stood at €25.49 in afternoon trading today.