Takeda surpasses Sotyktu of Bristol in AAD 2023.

Nimbus Therapeutics had a goal of developing a Tyk2 inhibitor that would be more effective than Bristol Myers Squibb’s Sotyktu, but with similar tolerability. This mission has been accomplished in treating psoriasis with the project, which is now under the control of Takeda and has been renamed TAK-279. This achievement was announced at the American Academy of Dermatology meeting on Saturday.

Although the results of the phase 2 study for TAK-279 were not as impressive as injectable medications, some investors viewed this as a positive development for oral alternatives yet to come. Takeda must also grapple with the hefty $4 billion cost of TAK-279. During a conference call, executive leaders refuted accusations that the company overpaid. However, the project's success may depend on Takeda's expansion into other conditions, such as inflammatory bowel disease and lupus.

Before moving forward, Takeda needs to confirm these results in the next phase of testing. The team has not revealed many details about the trial plan until it consults with regulators, but they suggested that they may conduct a comparison study using the maximum dose of 30mg that was examined during phase 3.

During the phase 2 trial, patients were given once-daily doses ranging from 2-30mg. The main goal was to determine how many patients achieved a Pasi 75 score, which measures a 75% improvement in the severity and area of psoriasis.

In terms of comparison across multiple trials, the bigger amounts of TAK-279 showed a slightly stronger effectiveness than Bristol's Sotyktu, which received approval for treating psoriasis in the previous year.

However, TAK-279 demonstrated its true potential under the stricter criterion of Pasi 100, which denotes completely clear skin. Takeda executives found the outcomes under this measure to be highly promising, indicating that its ability to differentiate from other psoriasis treatments was a significant advantage. The significance of achieving clear skin in treating psoriasis is also rapidly growing.

Despite being tested on both Pasi 75 and 100, TAK-279 did not perform as well as Abbvie's Skyrizi, which achieved success rates of up to 89% and 51%, respectively.

Certainly, Abbvie's medication requires an injection, whereas TAK-279 offers a simpler oral alternative. Yet, analysts from Stifel proposed that the most recent findings have failed to fully demonstrate the effectiveness of drugs like Ventyx's VTX958, which uses a Tyk2 inhibitor and will produce results from the Serenity phase 2 trial in treating psoriasis by the end of the year.

Takeda is equally concerned about the safety profile of TAK-279. Although there were no major concerns, executives agreed to monitor creatine phosphokinase levels closely as some patients experienced an increase in this enzyme. COVID infections and acne were the most frequent side effects, but it's still unclear if the inhibition of Tyk2 is related to acne. Graham Heap, Takeda's global program leader, made this statement.

In general, Takeda relied heavily on the phase 2 results in demonstrating the potential of their oral molecule to be one of the best in its class. However, there is a concern that its effectiveness may decrease from phase 2 to phase 3.

On Saturday's teleconference, Fumiyoshi Sakai, an analyst at Credit Suisse, described the psoriasis information as "OK." However, the Takeda executives opposed the statement made by Sakai.

Andy Plump, who is the president of R&D at Takeda, expressed that they believe the new molecule is not just good but amazing. For the past eight years, they have been examining different molecules to include in their GI and inflammation portfolio alongside Entyvio, and this is the one they finally decided to pursue.

Mr. Sakai argued that investing $4 billion solely for the treatment of psoriasis is not a justifiable decision.

According to Uthra Sundaram, who leads Takeda's global product and launch strategy, we did not pay a large sum of money for this asset. Sundaram also mentioned that Takeda has plans for dealing with inflammatory bowel disease (IBD), and phase 2 trials will commence this year. It's worth noting that Sotyktu had previously failed in treating ulcerative colitis. In regards to IBD, Mr. Heap, another Takeda representative, announced that the company will be testing a variety of TAK-279 doses.

According to Mr. Plump, the primary focus in Research and Development is to accelerate the program as a guiding principle. The team is prepared to act promptly and efficiently, making it their topmost priority at the moment.