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J&J’s Tremfya Study Shows Improvement In Crohn’s Disease Patients
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J&J’s Tremfya Study Shows Improvement In Crohn’s Disease Patients

Johnson & Johnson said Monday that its Tremfya drug induced clinical and endoscopic improvements in adult patients with moderately to severely active Crohn’s disease (CD).

The Phase 2 interim data from J&J’s (JNJ) study demonstrated that patients at 12 weeks of treatment with Tremfya, showed significantly greater improvements compared to placebo treatment across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is not currently approved for CD treatment in the US.

Tremfya is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. Tremfya is approved in the US, Canada, the European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis.

“For patients living with moderately to severely active Crohn’s disease, including those who have not had an adequate response or have intolerance to other therapies, these results show that Tremfya may play an important role as a new treatment option pending results from the ongoing registration trials,” said J&J’s Jan Wehkamp. “Although more research is needed, we are encouraged by the data and the potential role for selective IL-23 inhibition in helping patients manage their Crohn’s disease symptoms and treating the underlying disease process.”

The study evaluated the efficacy and safety of Tremfya compared with placebo in CD. The interim analyses reported results through week 12 from the first 250 patients enrolled. Approximately 50% of patients had previously failed biologic therapy. A significantly higher proportion of patients assigned to each Tremfya dose achieved clinical remission compared with placebo, the study showed.

Furthermore, at week 12, a “significantly higher” proportion of patients treated with Tremfya showed clinical response, patient reported outcome (PRO)-2 remission, clinical-biomarker response, and endoscopic response versus patients treated with placebo. Endoscopic healing is an important outcome for long-term disease control, the company said. The study results demonstrated that 37.3% of patients in the Tremfya-treated group had an endoscopic response after 12 weeks of induction treatment compared with 11.8% in the placebo group.

JNJ shares have more than fully recovered since plunging to a multi-year low in March and are now trading 3.5% higher than at the start of year. (See JNJ stock analysis on TipRanks).

Credit Suisse analyst Matt Miksic at the end of last month reiterated a Buy rating on the stock with a $163 price target (8% upside potential), saying that based on his analysis of July and August price-adjusted scrips and rebate-adjusted sales for JNJ’s largest US Pharma franchises, trends are tracking roughly in line with his Q3 estimates.

“Our analysis is based on price-adjusted scrip growth and IQVIA-reported sales growth for July and August for JNJ’s major US Pharma franchises,” Miksic wrote in a note to investors. “The strength in growth equates to $12 mil in sales upside for the quarter and 1c of theoretical EPS upside, by our estimate.”

Overall, the rest of the Street shares Miksic’s bullish outlook on the stock. The Strong Buy analyst consensus boasts 7 unanimous Buy ratings. That’s with a $166.86 average price target indicating upside potential of 11% in the coming 12 months.

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