A hero has arrived in Protagonist Therapeutics’ story, in the form of a Johnson & Johnson-partnered psoriasis med that has just cleared lesions in a mid-stage trial.
JNJ-2113, previously known as PN-235, met the main goal of the phase 2b FRONTIER 1 trial in patients with moderate-to-severe plaque psoriasis, Protagonist said in a Tuesday release. The therapy cleared the bar of achieving a 75% improvement in lesions at week 16 when compared to placebo in all five treatment groups in the study. The therapy was well tolerated and there were no meaningful differences in adverse events between the treatment and placebo arms.
JNJ-2113 is an oral Interleukin-23 receptor (IL-23R) antagonist peptide developed by Protagonist. The biotech amended a deal with J&J unit Janssen Pharmaceuticals in July 2021 to develop multiple IL-23R antagonists. Janssen offered up to $900 million in development and sales milestones and pledged to conduct all future clinical studies, including FRONTIER 1.
Protagonist kept the details short in Tuesday’s release, with plans to present the results at future medical meetings in the second quarter. But CEO Dinesh Patel, Ph.D., said the expectation is that JNJ-2113 will advance to a phase 3 registrational study “on the strength of these data.” He also hinted that the therapy could have a future in other IL-23-mediated diseases. Janssen is also advancing a couple of different formulations of the drug in other trials.
This was much-needed good news for Protagonist, which had a couple of major setbacks in 2022. In April, the FDA yanked a breakthrough designation for rusfertide, which is being developed for the red blood cell disorder polycythemia vera. The agency decided to pull the tag “based on observed malignancies,” which sent the biotech’s shares into a downward spiral.
Then a few weeks later, the company posted a failure of ulcerative colitis drug PN-943, which is being fielded as a challenger to Takeda’s blockbuster ulcerative colitis injection Entyvio. Protagonist tried to convince investors that the trial was a success given that the low-dose group showed improvement, but the primary endpoint was related to the high-dose group, which was unsuccessful. The company’s shares sunk to $9.41 the morning the PN-943 failure was announced on April 26, 2022.
But the shares have slowly climbed back up. Today’s news also helped push them up 15% to $17.55, compared to a prior close of $15.20.