Janssen Does Not Want Crohn’s Disease Asset Back from Provention Following Trial Failure

Shares of Provention Bio took a slight hit in premarket trading before rebounding after it was revealed that Janssen has no wish to buy back the rights to a mid-stage Crohn’s disease treatment following a mid-stage trial failure.

In a recent filing with the U.S. Securities and Exchange Commission, Provention said it was told by Janssen that the Johnson & Johnson subsidiary will not take up an option to buy back the rights to PRV-6527, an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor that was developed by Janssen and licensed to Provention in 2017. Janssen said it will “support and expand the field” of the agreement between the two companies to allow continued development of the asset. The expansion of the agreement will give Provention the right to aim the asset at other indications or possibly sublicense it to another company – which means Janssen does not want the property back.

According to the filing, Janssen will assist Provention in transferring the manufacturing rights of PRV-6527 to either Provention for continued development or assist in the transference of rights to a third party. Additionally, Janssen said it will “irrevocably waive its rights to assume distribution and pricing decision making authority” of PRV-6527, Provention said in the federal filing. Provention said it has no real intention of attempting to develop the asset any longer and could explore sublicensing the compound to a third party. 

In 2017, Janssen licensed PRV-6527 to Provention, along with PRV-300, an anti-Toll-Like Receptor 3 (TLR3) monoclonal antibody.

In October, Provention announced that PRV-6527 failed to hit endpoints in the Phase IIa PRINCE trial. The trial included patients with moderate-to-severe Crohn’s disease, the majority of which had never been treated with a biologic. The primary efficacy endpoint of the trial was change in the Crohn’s Disease Activity Index score at 12 weeks. At the end of the trial, the drug did not differentiate itself from placebo, although Provention sought to put a positive spin on it saying PRV-6527 demonstrated a “substantial improvement in this symptom-driven score” at 12 weeks. As BioSpace reported at the time, Provention said the “high placebo response” is related to the background medication about 85% of the biologic-naïve patient population were on. In the Phase IIa trial, PRV-6527 did show improvement in several key secondary objective endpoints in the steroid-free population, which was about 75% of the patients, as was previously reported. Those endpoints included mucosal endoscopy and tissue histology.

Following the Phase IIa failure, Provention said it was shifting its resources to focus on PRV-031 (teplizumab) for the prevention or delay of type 1 diabetes.