8-K: Protagonist Therapeutics Achieves $165 Million Milestone Following Positive Phase 3 Results for Psoriasis Drug

Protagonist Therapeutics has earned a $165 million milestone payment from Johnson & Johnson after positive Phase 3 trial results for their psoriasis drug, icotrokinra.

Summary

• Protagonist Therapeutics announced positive topline results from two Phase 3 clinical trials, ICONIC-LEAD and ICONIC-TOTAL, for their oral psoriasis drug, icotrokinra (JNJ-2113).
• The ICONIC-LEAD study showed that 64.7% of patients achieved clear or almost clear skin (IGA 0/1) at week 16, and 74.1% at week 24, compared to 8.3% on placebo at week 16.
• In the ICONIC-LEAD study, 49.6% of patients achieved a 90% improvement in psoriasis area and severity index (PASI 90) at week 16, and 64.9% at week 24, compared to 4.4% on placebo at week 16.
• The ICONIC-TOTAL study met its primary endpoint of IGA 0/1 at week 16 in patients with plaque psoriasis in difficult-to-treat areas.
• As a result of these positive results, Protagonist has earned a $165 million milestone payment from Johnson & Johnson, which includes $50 million in accelerated payments.
• The company is still eligible for up to $630 million in future development and sales milestone payments, plus tiered royalties of 6-10% on worldwide net sales.
• The $165 million payment is expected to be received in Q1 2025.

Sentiment

Score: 9

Explanation: The document conveys a very positive sentiment due to the strong Phase 3 results, the significant milestone payment, and the promising future outlook for icotrokinra. The company's management is clearly enthusiastic about the results and the potential of the drug.

Positives

• The Phase 3 ICONIC-LEAD study showed significant skin clearance with icotrokinra compared to placebo.
• The ICONIC-TOTAL study met its primary endpoint, demonstrating efficacy in difficult-to-treat areas.
• The safety data from the Phase 3 trials was consistent with previous Phase 2 studies.
• The company has secured a substantial $165 million milestone payment.
• There is potential for significant future revenue through additional milestone payments and royalties.

Negatives

• A similar proportion of patients experienced adverse events in both the icotrokinra and placebo groups, with 49.3% and 49.1% respectively experiencing a treatment emergent adverse event at week 16.

Risks

• The company's future success depends on the ability to develop and commercialize product candidates.
• The company faces competition from other pharmaceutical companies.
• The company's ability to obtain and maintain regulatory approval is not guaranteed.
• The company's ability to earn future milestone payments is not guaranteed.

Future Outlook

The company anticipates upcoming clinical study results for ulcerative colitis and psoriasis, as well as a potential psoriasis NDA submission in 2025. They also plan to initiate a Phase 3 study in psoriatic arthritis in early 2025.

Management Comments

• Dinesh V. Patel, PhD, President and CEO of Protagonist, stated that the Phase 3 results confirm the efficacy and safety trends observed in previous Phase 2 studies.
• Dr. Patel also highlighted the potential of icotrokinra as a best-in-class oral agent for treating plaque psoriasis.
• Dr. Patel expressed enthusiasm for icotrokinra heading into 2025, with upcoming Phase 2b ulcerative colitis results, presentation of ICONIC Phase 3 results at medical conferences, topline results from psoriasis superiority studies against deucravacitinib and a potential psoriasis NDA submission.

Industry Context

This announcement is significant as it demonstrates the potential of oral peptide therapies in treating chronic inflammatory conditions like psoriasis, which could offer a more convenient alternative to injectable biologics. The positive results position Protagonist as a strong player in the competitive psoriasis treatment market.

Comparison to Industry Standards

• The PASI 90 response rate of 64.9% at week 24 in the ICONIC-LEAD study is competitive with other advanced psoriasis treatments, including biologics and oral small molecules.
• For example, AbbVie's Skyrizi (risankizumab), a biologic, has shown PASI 90 rates of around 75% at week 16 in clinical trials, while Amgen's Otezla (apremilast), an oral small molecule, has shown lower PASI 90 rates of around 30-40%.
• The oral administration of icotrokinra offers a potential advantage over injectable biologics in terms of patient convenience.
• The safety profile of icotrokinra appears to be consistent with previous studies, which is important for its potential adoption.

Stakeholder Impact

• Shareholders will benefit from the positive clinical trial results and the milestone payment.
• Employees may experience increased job security and potential for growth.
• Patients with psoriasis may have a new and effective treatment option.
• Johnson & Johnson, as a partner, will benefit from the successful development of icotrokinra.
• Creditors may view the company more favorably due to the positive financial news.

Next Steps

• The company will prepare comprehensive results from both ICONIC-LEAD and ICONIC-TOTAL for presentation at upcoming medical congresses.
• The company will share the results with health authorities in planned submissions.
• Topline results for the Phase 2b ANTHEM study of icotrokinra for ulcerative colitis are expected in the first half of 2025.
• Topline results for the Phase 3 ICONIC-ADVANCE studies comparing icotrokinra to placebo and deucravacitinib are expected in the first half of 2025.
• An ICONIC-PsA psoriatic arthritis program evaluating icotrokinra will be initiated in the beginning of 2025.
• The company expects to receive the $165 million milestone payment in Q1 2025.

Key Dates

Keywords

icotrokinra, psoriasis, Phase 3 clinical trial, milestone payment, JNJ-2113, Johnson & Johnson, oral peptide, IL-23 receptor, PASI 90, IGA, biopharmaceutical