In The Pipeline: Phase 1, 2, and 3
- Phase 1 trial data reported in July 2023 for the topical cream GN-037 demonstrated a favorable safety and tolerability profile, and a Phase 2 clinical trial was initiated in patients with mild-to-moderate plaque psoriasis.
- A Phase 1 study to determine the safety, metabolism, and potential effect of small molecule drug SFA004 on mild-to-moderate chronic plaque psoriasis was started in 2022 and was expected to be completed this summer.
- Artax Biopharma, Inc., announced in February that the first patient had been dosed in the company’s Phase 2a trial evaluating the safety and biomarker responses of AX-158 in a first proof of mechanism trial in psoriasis. The company expected the results to be available in the second half of this year. AX-158 was described as the first immunomodulator in the Nck blocker class, and the company said pre-clinical data supported the potential for it to realize effective outcomes without the immunosuppression and the side effects associated with existing autoimmune disease therapies.
- Arctic Bioscience announced in January the completion of subject recruitment in the HeROPA Phase 2b clinical trial of the oral drug candidate HR0350 to treat mild-to-moderate psoriasis. HR0350 contains an oil-based extract from herring roe (Clupea harengus) in soft capsules and contains phospholipids (complex lipids) that are naturally rich in marine polyunsaturated fatty acids. All of the lipids are natural components of the human diet. It is not fully known how HR0350 exerts its effects, but there are indications that it might have a modulatory effect on the inflammatory processes involved in causing psoriasis. The randomized, double-blind, placebo controlled, dose finding, multi-center, Phase 2b study is expected to be completed in early 2025.
- Johnson & Johnson in February announced publication of the FRONTIER 1 Phase 2b trial results for JNJ-2113—the first investigational targeted oral peptide inhibitor designed to block the IL-23 receptor. The FRONTIER 1 clinical trial achieved the primary and all secondary efficacy endpoints evaluating JNJ-2113 in adults with moderate-to-severe plaque psoriasis. The primary endpoint of the study was a reduction from baseline of at least PASI 75 at Week 16. Study results demonstrated a significant dose-response on PASI 75 at Week 16 for adult patients who received JNJ-2113 compared to patients treated with placebo, with 79% of patients achieving a PASI 75 response in the highest dose group tested of 100 mg twice-daily.
- A Phase 2 study of rimegepant, an orally administered small molecule competitive inhibitor of the calcitonin gene-related peptide (CGRP) receptor, in moderate plaque-type psoriasis started in 2021 and was expected to be completed this August. Rimegepant has been approved by the FDA for the treatment of acute migraine, but it has not been studied in the treatment of moderate plaque-type psoriasis and is investigational for this indication.
- A Phase 2 study evaluating SGX302 (synthetic hypericin) in the treatment of mild-to-moderate psoriasis is expected to be completed in 2025. The study will utilize the topical hypericin ointment with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.
- A Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe plaque psoriasis was started in 2023 and is expected to be completed in mid-2025. It is designed to assess the therapeutic dose, efficacy, and safety of treatment with the novel oral TNFα inhibitor, which specifically inhibits TNFR1 signaling.
- A Phase 2 clinical trial to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA) was set to be completed in the first half of this year, though results had yet to be released as of late June.
- A Phase 2 study to explore the clinical efficacy and safety of the oral TYK2 inhibitor HS-10374 in the treatment of moderate-to-severe plaque psoriasis started in September 2023 and was expected to be completed in the third quarter of 2024. This study also aimed to find the optimal dosing for the future clinical development of HS-10374.
- Takeda in March announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858)—a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor—in patients with moderate-to-severe plaque psoriasis. The study met its primary and secondary endpoints, with a statistically significant greater proportion of TAK-279 patients achieving Psoriasis Area and Severity Index (PASI) 75, 90, and 100 in the 5-mg, 15-mg, and 30-mg dosing arms compared to placebo at 12 weeks.
- A Phase 3 clinical trial investigated the efficacy/safety of piclidenoson (CF101)—an orally bioavailable A3AR agonist from Can-Fite BioPharma Ltd. that inhibits IL-17 and IL-23 production in keratinocytes—in moderate-to-severe plaque psoriasis. Piclidenoson at 2 mg and 3 mg BID exhibited similar efficacy. The primary end point was met with the 3 mg BID dose: PASI 75 rate of 9.7% versus 2.6% for piclidenoson versus placebo, p = 0.037. The PASI responses with piclidenoson continued to increase throughout the study period in a linear manner. At week 32, analysis in the per-protocol population showed that a greater proportion of patients in the piclidenoson 3 mg BID arm (51/88, 58.0%) achieved improvement from baseline in Psoriasis Disability Index (PDI) compared to apremilast (59/108, 55.1%), and the test for noninferiority trended towards significance (p = 0.072). The safety/tolerability profile of piclidenoson was superior to apremilast. Can-Fite BioPharma Ltd. also announced in December that it received a positive response from the FDA on the Pediatric Study Plan for the treatment of children suffering from psoriasis with piclidenoson. The company said in a press release that it believes the inclusion of children in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug.
- A Phase 3 trial to assess whether the efficacy of CMAB015 is similar to that of secukinumab in patients with moderate-severe chronic plaque psoriasis was started in May and is expected to be completed in late 2025. It will also learn about the similarity of CMAB015 and secukinumab in terms of safety and immunogenicity in patients with moderate-severe chronic plaque psoriasis.
- SB17, from Samsung Bioepis Co., which had been found to be physiochemically similar and pharmacokinetically bioequivalent to ustekinumab in a Phase 1 study, was found to be clinically biosimilar up to week 28 in a Phase 3 study published in April. In this double-blind study, subjects were randomized to receive 45 mg of SB17 or ustekinumab subcutaneously at week 0, week 4, and every 12 weeks. The primary endpoint was the percent change from baseline in PASI at week 12 with an equivalence margin of [-15%, 15%]. Other secondary efficacy, safety, PK, and immunogenicity endpoints were measured through week 28. Adjusted difference of PASI change from baseline at week 12 of -0.6% (95% confidence interval; -3.780, 2.579) was within the equivalence margin. Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) were also comparable. Overall treatment-emergent adverse events were comparable.
- A multicenter, randomized, double-blind, placebo-controlled, randomized withdrawal and retreatment Phase 3 clinical trial evaluating the efficacy and safety of subcutaneous injection of IBI112 in the treatment of moderate to severe plaque psoriasis was started in October 2023 and is expected to be completed in late 2025. IBI112 is a highly potent anti-IL-23 monoclonal antibody that efficiently neutralizes IL23p19, a subunit of IL-23, to abrogate IL-23 binding to its receptor and block downstream signal transducer and activator of transcription 3 (STAT3) phosphorylation.
- A multicenter, randomized, double-blind, placebo-controlled Phase 3 study to assess efficacy and safety of the oral PDE4 drug Hemay005 in subjects with moderate-to-severe plaque psoriasis found that it significantly reduced the severity of moderate to severe plaque psoriasis over 16 weeks. Most adverse events were mild. E-R analysis showed that the optimal dose of Hemay005 was 60 mg.
- A Phase 3 multi-center, randomized, double blind, positive control Phase 3 clinical study to evaluate the efficacy and safety of the subcutaneous IL17A inhibitor LZM012 in moderate-to-severe chronic plaque psoriasis patients was started in August 2023 and is expected to be completed in mid-2025.
- Xeligekimab, a fully human monoclonal antibody from Genrix Biopharmaceuticals that selectively neutralizes IL-17A and had shown potential efficacy in preliminary trials, showed high efficacy and was well tolerated in a Phase 3 study of Chinese patients with moderate-to-severe plaque psoriasis. At week 12, the PASI 75/90/100 were achieved in 90.7%/74.4%/30.2% of patients in the GR1501 group, compared with 8.6%/1.4%/0% patients in the placebo group, respectively. The PGA 0/1 were achieved in 74.4% patients of the GR1501 group and 3.6% patients in the placebo group. The PASI 75 and PGA 0/1 maintained until week 52. No unexpected adverse events were observed.
- Bristol Myers Squibb in May revealed four-year data from the POETYK PSO long-term extension trial of deucravacitinib in treating moderate-to-severe plaque psoriasis. The study followed the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, with patients receiving an open-label 6-mg dose daily. After four years, the PASI 75 and 90 response rates were 71.7% and 47.5%, respectively. The safety profile remained consistent over four years, with no new safety concerns identified.
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