J&J clears PhII for rare blood disorder with drug from $6.5B Momenta buyout
The lead drug from Johnson & Johnson’s $6.5 billion buyout of Momenta, now being tested in nearly 10 indications, has cleared a Phase II in a rare blood disorder.
J&J’s therapeutics unit Janssen was sparse on details but said the drug, nipocalimab, met the primary endpoint in the UNITY study. The majority of pregnant patients in the trial experienced a live birth at or after 32 weeks without requiring intrauterine transfusion, or IUT, the Big Pharma said on Monday.
Janssen touts nipocalimab as the only therapeutic being investigated in the clinic for treating alloimmunized pregnant adults at risk of severe hemolytic disease of the fetus and newborn, or HDFN, in which antibodies from the pregnant person attack fetal red blood cells, which leads to anemia in the fetus.
The disease occurs in about 80 out of every 100,000 pregnancies in the US, Janssen said, noting no approved drugs exist today. The invasive IUT surgery, sometimes done repeatedly, is the standard procedure. In the 14-person study, people in the US, Canada, Australia and Europe received the drug intravenously once a week.
The drugmaker is shaping up plans for a pivotal Phase III and will present more details of the mid-stage UNITY trial at a scientific medical meeting, Janssen said. The safety profile during the 20-week treatment period “supports further development,” per the company’s press release.
“These early results represent an important step towards delivering a potential medication for expectant mothers at high risk of severe HDFN, and we are encouraged by what this treatment could mean for families affected by this potentially devastating disease,” Katie Abouzahr, Janssen’s VP of autoantibody development, said in a statement.
For HDFN, Janssen’s drug has fast track and orphan drug tags in the US and an orphan designation in the EU.
Janssen is also testing the drug in more than half a dozen neuroscience and immunology indications, including rheumatoid arthritis, for which a Phase II readout is expected this year. All told, the pharma giant thinks the drug can top $5 billion in eventual annual sales.