Clinical Takeda's Autoimmune Therapy Shows Effectiveness in Major Trial

Takeda’s Autoimmune Therapy Shows Effectiveness in Major Trial


Takeda has revealed the information that prompted them to buy the TYK2 inhibitor from Nimbus Therapeutics for $4 billion. In a major trial, one-third of participants who received the highest dose had their psoriasis completely eradicated, indicating that the candidate has a better response rate compared to Bristol Myers Squibb’s Sotyktu medication.

Earlier this year, Nimbus announced that the primary goal of a phase 2b clinical trial involving patients with moderate to severe plaque psoriasis was achieved by its TYK2 inhibitor, now called TAK-279. The biotech company claimed that the statistics support its best-in-class potential but did not share the data to support the statement. Takeda confirmed the assertion by paying $4 billion upfront for the phase 3-ready candidate.

The findings of the 12-week clinical trial have now been released by Takeda. The Japanese pharmaceutical company announced at the American Academy of Dermatology Annual Meeting that, according to the Psoriasis Area and Severity Index (PASI), 68% and 67% of patients at the intermediate and high dose levels achieved a 75% remission of their symptoms. In the placebo group, the PASI 75 rate was only 6%.

The difference in PASI 75 was significant enough to support the main objective of the study and raises the possibility that the drug candidate may outperform BMS’ Sotyktu, which led to 75% reductions in the area and severity of psoriasis in 53% and 58% of patients in two 16-week phase 3 clinical trials.

Examining PASI 90 and PASI 100, which measure the percentage of patients with 90% and 100% symptom remission, provides potential benefits of TAK-279 versus Sotyktu. 46% of patients in the high-dose TAK-279 group achieved a PASI 90, and 33% achieved complete resolution.

Graham Heap, the R&D global leader of the program at Takeda, stated, “The portion of patients achieving PASI 90 and PASI 100 already at Week 12 is particularly encouraging. We know that achieving clear or nearly clear skin, PASI 90, and importantly PASI 100, is increasingly recognized as a therapeutic goal in psoriasis. It’s difficult for us to do cross-trial comparisons with any other agents, but still, TAK-279 may have an advantage. The offer is a compelling proposition compared to the figures of the competition.”

The PASI 90 and 100 rates in the Sotyktu trials were 27% and 36%, and 10% and 14%, respectively. Compared to Sotyktu, TAK-279 produced higher rates of PASI 90 and PASI 100 in less time, but it is still uncertain if the investigational candidate is more efficient because of the relatively small Takeda study and the reliability of cross-trial comparisons.

Takeda will continue to speak with authorities over the next few weeks and months and release details on the study’s design as soon as the talks are finished. A head-to-head study in psoriasis has become increasingly common. The high figures of PASI 100 in the 30mg testing have put Takeda’s medication in a unique position. The company believes that patients do not need to be kept on a lower dose. Several plans in the future are in place to test other candidates for diseases such as systemic lupus erythematosus and inflammatory bowel disease

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