Aslan Pharmaceuticals has seen multiple trial flops, restructuring and cuts over the past few years; now, it has been beset by pandemic woe.
The Singapore company said Monday morning that ASLAN004, the anti-IL-13Rα1 antibody licensed from CSL it's positioned to try to take on Regeneron and Sanofi’s blockbuster Dupixent, has seen patient recruitment paused for an ongoing test in severe atopic dermatitis.
Aslan says this is down to the spread of the novel coronavirus, which is affecting almost every trial around the world. The company said it would “resume screening as soon as government restrictions are lifted and is taking steps to open sites in Australia to accelerate recruitment.”
The biotech added, however, that the study “remains on track” to report interim, unblinded data from all three dose cohorts in its multiple ascending dose study in the third quarter, saying it does not “expect these measures to materially affect the projected timelines.”
Aslan was recruiting patients into the second of three dose cohorts. This comes after studies in its native Singapore, other than those related to COVID-19, have paused recruitment “in line with the recent restrictions on movement of the public to contain the spread of COVID-19.”
It adds that here, too, it will resume screening of new patients “as soon as these restrictions are lifted,” which is slated for May 4.
Carl Firth, Aslan’s CEO, said: “It is vital that hospitals and other medical services focus their limited resources on helping the millions affected by COVID-19. We are hopeful that by taking these necessary measures, the outbreak will soon be brought under control and we can resume our studies safely.”
Last May, Aslan secured the global rights to ASLAN004 from CSL. This was a revision of its original deal, which tied Aslan to milestones including a $30 million payment when ASLAN004 enters phase 3.
Aslan first secured a stake in ASLAN004 all the way back in 2014. That deal tasked Aslan with taking the drug up to clinical proof of concept in an Asian-centered development program and then partnering up for phase 3 development and commercialization. CSL would receive 40% to 50% of the proceeds of the outlicensing agreement and any other revenues related to ASLAN004.
But under the new-look pact, Aslan claimed full global rights to ASLAN004 for itself. That committed Aslan to the aforementioned phase 3 payout, up to $95 million in regulatory milestones and as much as $655 million in fees tied to the commercial success of ASLAN004. CSL will receive sub-10% royalties, too.
ASLAN004, then known as CSL334, was seen as a potential treatment for asthma when Aslan struck the original deal in 2014. But the focus of ASLAN004 development has shifted to atopic dermatitis.
Regeneron and Sanofi showed the therapeutic impact of inhibiting the signaling of both IL-4 and IL-13 through the development of Dupixent.
The data got Dupixent to market and are driving blockbuster sales but have failed to deter rivals from the atopic dermatitis market.