Newsoara completes Phase 3 test of oral PDE4 drug HPP737 in psoriasis
The 607-patient China trial closed on schedule, positioning HPP737 as a same-class entrant among six direct PDE4 rivals rather than a novel mechanism.
Executive Summary
- Newsoara HYK Biopharmaceutical completed enrollment and dosing in a Phase 3 trial of its oral PDE4 inhibitor in adult plaque psoriasis, closing on its registered completion date.
- The trial is designed to test whether the drug reproduces the skin-clearance response rates that define its mechanism class, the threshold any new PDE4 inhibitor in this indication must clear to compete.
- The drug is not first to test this mechanism in psoriasis: it joins a field of same-target oral PDE4 inhibitors already in Phase 3 testing, so differentiation will rest on the trial's results rather than the mechanism itself.
- The efficacy and safety results from this trial, not yet posted, are the event that will determine whether the program advances toward a regulatory filing in China.
The trial
NCT07712731 is a randomized, triple-masked, two-arm Phase 3 study of HPP737, an oral small-molecule PDE4 inhibitor, in adults with stable moderate-to-severe plaque psoriasis. The trial enrolled 607 patients across sites in China, starting April 18, 2025, and reaching its registered primary completion date of April 1, 2026. The primary endpoints measure the proportion of patients achieving PASI 75, a 75% reduction from baseline in the Psoriasis Area and Severity Index, and the proportion achieving an sPGA score of clear or almost clear, both assessed at week 16. Secondary endpoints track BSA, DLQI quality-of-life scores, pharmacokinetics, and adverse-event incidence through 16 to 18 weeks. The trial is designated registrational. NCT07712731HPP737 in Adult Patients With Plaque PsoriasisNCT07712731
What the readout will test
No results have posted on ClinicalTrials.gov for this study. The trial is the sponsor's third clinical study of HPP737 in plaque psoriasis, following a 515-patient placebo-controlled trial that completed its primary endpoint assessment in September 2023 and a 123-patient Phase 2 study that completed in December 2021. Because HPP737 is already in its second placebo-controlled Phase 3 program for this indication, the bar for this trial is replication of a response rate consistent with the PDE4-inhibitor class in psoriasis, not a novel efficacy signal. NCT07712731HPP737 in Adult Patients With Plaque PsoriasisNCT07712731
Competitive position
HPP737 is not the only oral PDE4 inhibitor being tested in plaque psoriasis or closely related inflammatory skin disease. Six direct comparators share the same target and small-molecule modality, including Amgen's apremilast, already approved for plaque psoriasis, psoriatic arthritis, and Behçet's-associated oral ulcers, and mid-stage programs from Ganzhou Hemay Pharmaceutical (mufemilast), Otsuka Pharmaceutical (difamilast), and Haisco Pharmaceutical (HSK44459), the last two tested in atopic dermatitis rather than psoriasis directly. Apremilast's approval covers plaque psoriasis, psoriatic arthritis, and Behçet's oral ulcers, but not this trial's exact patient population without further scoping. PDE4-targeted trial activity in psoriasis has slowed, with 15 recent trials against 198 older ones in the broader target field, even as the indication itself stays active with newer IL-17, IL-23, and JAK-pathway entrants from Takeda, Bristol-Myers Squibb, and AbbVie running larger Phase 3 programs. Against that backdrop, a PASI 75 response rate that matches or exceeds apremilast's established range would be the result that keeps HPP737 competitive within its own mechanism class.
Operational read
The trial's operational profile is unremarkable: it enrolled to its full target of 607 patients, its primary completion date landed as registered, and its amendment history shows no material protocol changes. The sponsor's broader pipeline includes 12 trials across four completed, three recruiting, three of unknown status, and two not yet recruiting. NCT07712731HPP737 in Adult Patients With Plaque PsoriasisNCT07712731
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.