Merck KGaA returns PhII multiple sclerosis drug to Apitope

Merck kgaa

Merck KGaA has returned a Phase II multiple sclerosis drug to Apitope. The German drugmaker picked up the rights to the peptide-based therapeutic in 2009 and advanced it to the cusp of a Phase IIa readout, but has now decided to relinquish its claim on the drug.

ATX-MS-1467, the drug at the center of the deal, came through a pair of Phase I trials during Merck KGaA’s time at the helm of the development program. And, on the back of data from those trials, Merck KGaA kicked off a 93-person Phase IIa study. Data from the trial are due to drop before the end of the year, but Merck KGaA isn’t sticking around to take the drug any further down the pipeline.

Apitope, a biotech with one foot in Belgium and another in the United Kingdom, is spinning the news as a boost for its prospects.

“This will provide us with greater flexibility and control in the clinical development of ATX-MS-1467,” Apitope CEO Keith Martin said in a statement. “We are now able to pursue new business collaborations to enable the further development of this promising treatment.”

Under the terms of the original deal, Apitope picked up an upfront fee of undisclosed size as part of a package of milestones and other payouts totaling up to €154 million ($169 million). With Merck KGaA having picked up the tab for development of ATX-MS-1467, the return of the rights to the drug could prove profitable for Apitope, assuming it can parlay the data generated on its ex-partner’s dime up into a deal with more favorable terms.

The likelihood of that happening depends on the strength of the data generated in the Phase IIa. Merck KGaA wrapped up the open-label proof-of-concept study earlier this year, but neither it, nor Apitope, have shared a look at the data yet. The trial assessed the change in the number of time constant 1 contrast-enhanced lesions after treatment with ATX-MS-1467.