Biogen boasts PhII win in lupus — will anyone turn their head from Alzheimer's to notice?
As the gaze on aducanumab intensifies in the runup to Biogen’s hotly-anticipated data presentation at an Alzheimer’s conference this week, the biotech is offering some relief in the form of positive Phase II results for a lupus drug.
Dubbed BIIB059, the little known antibody delivered clean hits on the primary endpoints for both parts of the study, involving patients with cutaneous lupus erythematosus and systemic lupus erythematosus, respectively.
The results are encouraging and add a third dimension to the Biogen story outside of Tecfidera IP and the Alzheimer’s program, wrote Evercore ISI analyst Umer Raffat in a note titled “sleeper hits”:
The MOA is broadly similar to AZN anifrolumab (AZN is an IFN blocker … BIIB is NOT a direct IFN blocker – directed against BDCA2) – which recently worked in Ph 3 TULIP-2 trial.
Unlike AstraZeneca’s TULIP-2, where efficacy was reported in terms of responders percentage (percentage of patients who had a 50% reduction in the CLASI score), in the LILAC study Biogen measured the reductions in CLASI on three doses of the drug.
In the CLE portion, BIIB059 induced reductions in disease area and severity by at least 40%: the 50mg group experienced reductions of 40.9% (p=0.008), the 150mg group 48% (p=0.001) and the 450mg group 40.9% (p=0.008). The placebo arm saw an average 14.5% improvement on the score, which measures skin disease activity.
As for SLE, the total number of tender or swollen joints, a common symptom, was the proxy for efficacy. All 132 SLE patients enrolled in the trial were given either a 450mg dose or placebo, and the treatment difference at week 24 was -3.4 (p-0.037).
Whether limited to the skin (CLE) or systemic (SLE), lupus has notoriously defeated multiple attempts at a viable treatment. Biogen has run into a wall with a late-stage anti-CD40L drug partnered with UCB, and a few years ago scrapped several other R&D projects in the area including a therapy targeting the TWEAK immune cell.
Back in 2016 Biogen was spotted sneaking a Bruton’s tyrosine kinase inhibitor into the clinic as a potential treatment for SLE. That Phase I study has been completed, but BIIB068 is now nowhere to be seen in Biogen’s pipeline and its status is unclear.
Despite the confidence boost that the topline numbers inject, though, Evan Seigerman of Credit Suisse said Biogen still has a lot to prove, from overcoming challenges with diagnosis and variable clinical features to safety.
“No substantial information was provided regarding safety (reportedly will be presented at future medical meeting),” he noted. “We await more details over safety, given that higher doses demonstrated better efficacy while only the 450mg dose was statistically significant for SLE. Furthermore, the large spread between 150mg and 450mg could potentially lead to increased safety signals.”
BIIB059 is designed to target blood dendritic cell antigen 2, or BDCA2, a receptor expressed on a subset of immune cells known as plasmacytoid dendritic cells. The subcutaneous injection, the theory goes, can block the cells’ production of inflammatory cytokines such as type-I IFN, thereby blunting the autoimmune attack on patients.
Nathalie Franchimont, VP in charge of the lupus and multiple sclerosis unit, hoped “these results support Biogen’s goal of continuing to build a multi-franchise portfolio.” But the tiny movement in Biogen’s stock price $BIIB suggested investors are not quite ready to buy in.