Phase 2b Clinical Trial Results for TYK2 Inhibitor Presented at American Academy of Dermatology Annual Meeting

Rhea-AI Summary

Takeda's TAK-279, an allosteric TYK2 inhibitor, showed promising results in a Phase 2b clinical trial for moderate-to-severe plaque psoriasis, presented on March 18, 2023, at the AAD Annual Meeting. Involving 259 patients, the trial demonstrated significant efficacy with patients on TAK-279 achieving PASI 75 (44%-67%), PASI 90 (21%-46%), and PASI 100 (10%-33%) compared to placebo (6%, 0%, 0%, respectively; p<0.001). Notably, the 2mg dose did not show significant benefits. Nimbus Therapeutics highlighted the unmet need addressed by TAK-279, steering towards further development in immune-mediated diseases.

Positive

• PASI 75 reached 44%, 68%, and 67% for TAK-279 doses (5mg, 15mg, 30mg) compared to 6% for placebo.
• PASI 90 reached 21%, 45%, and 46% for TAK-279 (5mg, 15mg, 30mg) versus 0% for placebo.
• PASI 100 reached 10%, 15%, and 33% for TAK-279 (5mg, 15mg, 30mg) versus 0% for placebo.
• Significant PGA scores of 0/1 achieved by 27%, 49%, and 52% for TAK-279 doses.

Negative

• The 2mg dosing arm showed no significant differences from placebo in PASI and PGA response rates.

BOSTON--(BUSINESS WIRE)-- Results from the Phase 2b clinical trial of TAK-279 (formerly NDI-034858), a novel allosteric TYK2 inhibitor developed by Nimbus Therapeutics and owned by Takeda (TSE:4502/NYSE:TAK), in patients with moderate-to-severe plaque psoriasis were presented on Saturday, March 18, 2023 at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans.

The results were presented as part of the Late-Breaking Research session by April Armstrong, M.D., MPH, clinical investigator in the Phase 2b study and Associate Dean and Professor of Dermatology at the University of Southern California.

From Takeda’s press release dated March 18th:

In the Phase 2b study, 259 patients were randomized (1:1:1:1:1 ratio) to receive one of four doses of TAK-279 once-daily, or placebo for 12 weeks. Results showed:

• A significantly greater proportion of TAK-279 patients achieved PASI 75 (44%, 68%, 67%; 5mg, 15mg, 30mg, respectively) versus placebo (6%; p<0.001), meeting the study’s primary endpoint.
• A significantly greater proportion of TAK-279 patients achieved PASI 90 (21%, 45%, 46%; 5mg, 15mg, 30mg, respectively) versus placebo (0%; p<0.001), and PASI 100 (10%, 15%, 33%; 5mg, 15mg, 30mg, respectively) versus placebo (0%; p<0.001 at 30mg).
• A significantly greater proportion of TAK-279 patients achieved Physician Global Assessment (PGA) scores of 0/1 (27%, 49%, 52%; 5mg, 15mg, 30mg, respectively) or 0 (10%, 15%, 33%; 5mg, 15mg, 30mg, respectively) versus placebo (4% [p≤0.001] and 0% [p<0.001 at 30mg], respectively) at 12 weeks. A PGA score of 1 indicates almost clear skin and 0 indicates totally clear skin.
• There were no statistically significant differences in PASI or PGA response rates seen in the TAK-279 2mg arm (18%, 2%, 10%, 2%; PASI 75, PASI 100, PGA 0/1, PGA 0, respectively) compared to placebo.

“We are thrilled to see this data shared with the scientific community, underscoring this medicine’s potential to address the high unmet need among patients with psoriasis and other immune-mediated diseases,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “This marks a turning point to the next ‘chapter’ of Nimbus. We have advanced our leading-edge technologies and grown our expertise in small molecule drug development to deliver breakthrough medicines, by design, for the benefit of patients.”

About Nimbus Therapeutics
Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. Nimbus combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, inflammatory and autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, MA. To learn more about Nimbus, please visit www.nimbustx.com.

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Chris Railey, +1 (617) 834-0936

Ten Bridge Communications

chris@tenbridgecommunications.com

Source: Nimbus Therapeutics

FAQ

What were the results of the TAK-279 Phase 2b clinical trial?

The trial showed significant efficacy with PASI 75 responses of 44% to 67% for TAK-279 doses compared to 6% for placebo, and PASI 90 responses of 21% to 46%.

What is the purpose of the TAK-279 clinical trial?

The trial aimed to evaluate the efficacy and safety of TAK-279 in patients with moderate-to-severe plaque psoriasis.

When were the results of the TAK-279 trial presented?

The results were presented on March 18, 2023, at the American Academy of Dermatology Annual Meeting.

What is the significance of the PASI scores in the trial?

PASI scores measure the severity of psoriasis, and the trial's results indicate significant improvements in patients treated with TAK-279 compared to placebo.

What are the next steps for TAK-279 after the trial?

Following positive trial results, further development and potential regulatory submissions are likely to advance TAK-279 in treating psoriasis and possibly other immune-mediated diseases.