Atlantic starts rolling FDA submission for antisense drug

FDA
Atlantic Healthcare filed the nonclinical part of its alicaforsen enema submission with the FDA.

Atlantic Healthcare has started a rolling submission for its antisense drug alicaforsen enema. The transatlantic pharma company got the process going by filing its nonclinical package with the FDA, positioning it to hit the ground running if its phase 3 trial in a rare form of inflammatory bowel disease (IBD) delivers positive data.

Cambridge, U.K.-based Atlantic agreed to a rolling submission for fast-tracked, ICAM-1-targeting antisense drug alicaforsen enema after meeting with the FDA in December. The staged regulatory process means Atlantic can submit sections of its filing for FDA review as and when they are ready, as opposed to waiting until the full submission is prepared. Atlantic took advantage of this option this week by sending its nonclinical package to the FDA.

The submission kicks off a process Atlantic hopes will lead to the filing of phase 3 data and, beyond that, the approval of alicaforsen enema in the U.S. Atlantic is currently trialing the candidate in a 138-person placebo-controlled phase 3 trial. The study is designed to show whether 6 weeks of daily dosing with the antisense drug increases the proportion of pouchitis patients who experience endoscopic remission and a reduction in relative stool frequency.

Atlantic raised $24 million (€22 million) to fund the trial through to completion last year. That round brought some of the team who led Salix Pharmaceuticals to its $11 billion takeover by Valeant—and through its failed merger and accounting scandal—on board as investors in Atlantic. The transatlantic pharma also secured the services of Salix scientific founder Lorin Johnson, Ph.D., who signed up to be a non-executive director and chief scientific adviser.

The phase 3 data will shape whether the investments prove to be prudent. Atlantic sees alicaforsen enema, which it licensed from Ionis Pharmaceuticals, acting as a launchpad for its business, first by capturing the pouchitis market and then by moving into the bigger indications of Crohn's disease and ulcerative colitis.

Ionis developed alicaforsen as an intravenous treatment for Crohn’s before offloading the rights to the drug to Atlantic, which repositioned the asset as a topical formulation. The hope is switching to a topical formulation will minimize side effects while ensuring the drug interacts with the ICAM-1 cell-surface proteins that are overexpressed in IBD patients.