dm+d

Unassigned

New Medicines

Camligo Pouchitis

Information

Camligo
New molecular entity
Atlantic Healthcare
Atlantic Healthcare

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes
Sep 20Company pipeline lists alicaforsen enema as in development for ulcerative colitis, with no specific mention of pouchitis. However, it seems the company do still plan to file in the EU despite the pivotal study not meeting its co-primary endpoints. It is unclear whether the company is planning any additional studies to explore efficacy in particular patient subgroups, or what happened to the US filing [10-13].
May 17rolling NDA submission initiated with filing of the non-clinical data package [7].
Jan 17FDA have accepted request for rolling submission of a NDA; Atlantic Healthcare expect to complete the application Q2 2017 [6].
May 16Launch estimate now 2018; PIII trial still underway with results expected Q2 2017 [5].
May 14Orphan drug designation and fast track status in the US also orphan drug in the EU [1].

Category

Inhibition of ICAM-1 production
Pouchitis is inflammation of the ileal pouch (an artificial rectum surgically created out of ileal gut tissue in patients who have undergone a colectomy), which is created in the management of patients with ulcerative colitis. The incidence of a first episode of pouchitis at 1, 5 and 10 years post-operatively is 15%, 33% and 45% respectively [2]
Pouchitis
Rectal

Trial or other data

Jul 19Atlantic Healthcare announced that the PIII (NCT02525523) trial did not meet its co-primary endpoints of improvement in endoscopic healing and reduction in bowel frequency at week 10. However, a benefit in stool frequency and endoscopic response was achieved in subgroups of patients. The company plan to meet with the US and EU regulators to discuss a pathway to approval [9].
Oct 18 Phase III trial (NCT02525523) in pouchitis patients who have failed to respond to at least one course of antibiotics completed [8]
Feb 16Company announce that the PIII trial (NCT02525523) recruitment has started in the US, Canada, the EU, and Israel; results are expected Q2 2017 [5].
Aug 15A randomised, double-blind, placebo-controlled phase III trial to evaluate the safety and efficacy of alicaforsen, administered via enema, in patients with chronic, antibiotic-refractory primary idiopathic pouchitis (NCT02525523) is listed but is not yet open for recruitment. The primary endpoint is the proportion of patients with endoscopic remission and reduction in relative stool frequency at week 10. The trial is designed to enrol approximately 138 patients in the US and the UK [3,4].
May 14In an open-label, uncontrolled PII trial, 12 patients with chronic, unremitting pouchitis received 240mg of alicaforsen nightly for six weeks by enema administration, and were followed for up to one year. The patients enrolled in the trial had failed treatment with a wide variety of alternative therapies. Mean Pouchitis Disease Activity Index (PDAI) for all patients in the study decreased from a baseline value of 11.4 to 6.8 after six weeks of treatment. Remission is traditionally defined by a value less than 7. The mean clinical PDAI score decreased rapidly from a baseline value of 9.0 to 4.4 (p = 0.002) at 6 weeks and was maintained through week 10. Patients within the trial experienced a significant improvement in mean endoscopic scores after 6 weeks of treatment (from baseline value of 5.3 to 2.6, p=0.0005) with sustained improvement of up to nine months [1].

Evidence based evaluations