Johnson & Johnson has landed rights to Protagonist Therapeutics’ preclinical Crohn’s disease asset PTG-200. The deal gives J&J a stake in an oral interleukin-23 (IL-23) receptor antagonist in return for $50 million upfront and up to $940 million in milestones.
PTG-200, like other candidates developed by Protagonist, is an oral therapy, a delivery method that sets it apart from other Crohn’s drugs. J&J first expressed an interest in the technology by investing in the biotech. Having tracked the oral peptide specialist’s progress, J&J has now swooped to add the candidate to its pipeline.
The asset is due to enter the clinic this year. Protagonist will run and fund the trial with J&J taking over—and covering 80% of the costs—once it advances to phase 2. Beyond this, a series of major paydays await Protagonist. J&J will pay Protagonist $125 million if it moves the drug into phase 2b and a further $200 million if it sticks with the asset after getting a look at data from the trial. The rest of the cash is tied to regulatory and sales milestones.
Protagonist has structured the deal to allow it to continue to play an active role in PTG-200 at these advanced stages. Specifically, Protagonist has the option to use its own sales force to support the commercialization of the drug in the U.S.
For J&J, the deal gives it an oral asset, albeit one yet to enter the clinic, to bolster its efforts to equip its pipeline to fend off competition in the field.
The target of PTG-200 is familiar to J&J. Stelara, a J&J drug the FDA approved in Crohn’s disease in November, hits IL-12 and IL-23. IL-12 is a long-standing target of interest in Crohn’s but over the past decade, researchers have generated evidence suggesting IL-23 plays a bigger role in the disease.
AbbVie is looking to test this idea with risankizumab, an IL-23 inhibitor it licensed from Boehringer Ingelheim. Phase 2 data shared last year suggest risankizumab may deliver similar improvements to Stelara despite not acting on IL-12. If phase 3 trials support that preliminary conclusion, AbbVie could steal share from J&J in Crohn’s and other indications by arguing risankizumab is as effective as Stelara and free from the complications that can arise when IL-12 is targeted.
In PTG-200 J&J has gained an asset that could enable it to retake the market if this scenario plays out. As PTG-200 targets a well-validated pathway, the novelty of its oral delivery technology is perhaps the most likely source of stumbling blocks. Protagonist has gone some way to alleviating such concerns with the clinical data it has generated on its lead candidate PTG-100 to date.