September 23, 2026

Zealand-Roche Petrelintide Phase 3 Starts, Sefaxersen IgAN Phase 3 Win, AC Immune Parkinson's Peptide Vaccine Data

Zealand and Roche start a 7,000-person petrelintide Phase 3, sefaxersen hits its IgAN Phase 3 goal, and AC Immune's peptide vaccine clears a Parkinson's test.

6 stories · Covering clinical-trials, industry

Editor's Note

Amylin moved into registration trials this week. Zealand Pharma and Roche started the three-trial ZUPREME Phase 3 program for petrelintide, about 7,000 people in total, each trial measuring weight change at week 64. A cardiovascular-disease cohort of about 2,500 people sits inside the registration package rather than after approval, so the tolerability case Zealand built in Phase 2 will be tested on a sicker population from the start. Two late-stage readouts outside obesity arrived without effect sizes: Roche's antisense drug sefaxersen met its 37-week proteinuria endpoint in IgA nephropathy, and Amgen's dazodalibep met its 48-week disease-activity endpoint in Sjögren's disease, so the size of each benefit waits for a medical meeting. AC Immune's ACI-7104, a vaccine built on an eight-amino-acid alpha-synuclein peptide, produced antibodies in every treated patient but has not yet shown a clinical effect, and the company plans to meet the FDA in early 2027 before a larger Phase 2. Novartis added a preclinical radioligand from Suzhou-based BoomRay in a deal worth up to $900 million, one day after the Telix–ITM merger, and Immunovant dropped cutaneous lupus after IMVT-1402 missed its week-12 endpoint.

Clinical Trials

Zealand Pharma and Roche Start Registrational Phase 3 ZUPREME Program for Once-Weekly Petrelintide in About 7,000 People with Overweight or Obesity

Zealand Pharma announced on September 22, 2026 the start of the Phase 3a ZUPREME program for petrelintide, its once-weekly subcutaneous amylin analog partnered with Roche. The three placebo-controlled trials are ZUPREME-3 (about 3,900 people with overweight or obesity and at least one weight-related comorbidity, without type 2 diabetes), ZUPREME-4 (about 600 people with type 2 diabetes), and ZUPREME-5 (about 2,500 people with established cardiovascular disease). Each trial's primary endpoint is percentage change in body weight from baseline to week 64. A Phase 2 trial combining petrelintide with Roche's GLP-1/GIP agonist enicepatide (CT-388) is planned for the second half of 2026.

#zealand-pharma #roche #petrelintide #amylin #obesity #phase-3

Clinical Trials

AC Immune's ACI-7104 Alpha-Synuclein Peptide Vaccine Meets Week-100 Safety and Immunogenicity Endpoints in Part 1 of Phase 2 VacSYn Parkinson's Trial

AC Immune reported on September 23, 2026 that Part 1 of VacSYn, a randomized, double-blind, placebo-controlled Phase 2 trial in early Parkinson's disease, met all of its primary safety, tolerability, and immunogenicity endpoints through week 100. Thirty-four patients were randomized 3:1 to ACI-7104 or placebo; the company said 100% of patients developed antibodies against the PD01 antigen after three immunizations, antibodies reached the cerebrospinal fluid in all patients, and the vaccine was generally safe and well tolerated. ACI-7104.056 uses an eight-amino-acid peptide that mimics a C-terminal alpha-synuclein epitope, conjugated to keyhole limpet hemocyanin, according to Alzforum. AC Immune reported a CSF total alpha-synuclein signal consistent with target engagement but no clinical efficacy result, and plans FDA meetings in early 2027 before an expanded Phase 2.

#ac-immune #aci-7104 #peptide-vaccine #alpha-synuclein #parkinsons

Clinical Trials

Roche and Ionis Report Sefaxersen Met 37-Week Proteinuria Endpoint in Phase 3 IMAgINATION Interim Analysis in IgA Nephropathy

Roche said on September 23, 2026 that a prespecified interim analysis of the Phase 3 IMAgINATION trial found sefaxersen produced a statistically significant reduction in 24-hour urine protein-to-creatinine ratio versus placebo at 37 weeks in adults with primary IgA nephropathy at high risk of progression. The trial randomized 459 people 1:1 to sefaxersen, a once-monthly subcutaneous antisense drug that reduces liver production of complement factor B, or to placebo for 105 weeks. Roche did not disclose the size of the proteinuria reduction; the trial remains blinded to week 105 to measure change in eGFR, and safety was consistent with prior data. Roche licensed sefaxersen from Ionis.

#roche #ionis-pharmaceuticals #sefaxersen #iga-nephropathy #antisense #non-peptide

Clinical Trials

Amgen's Dazodalibep Meets 48-Week ESSDAI Primary Endpoint in Phase 3 OASIZ 301 Trial in Moderate-to-Severe Systemic Sjögren's Disease

Amgen announced on September 22, 2026 that OASIZ 301, a randomized, double-blind, placebo-controlled Phase 3 trial in about 621 adults with Sjögren's disease and moderate-to-severe systemic activity (ESSDAI of 5 or higher), met its primary endpoint of change from baseline in ESSDAI at week 48. Amgen described the improvement as statistically significant and seen as early as week 4, but did not release effect sizes. The company describes dazodalibep as a potential first-in-class CD40L antagonist fusion protein. The most common adverse events were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions; a second Phase 3 trial, OASIZ 303, is expected to complete in the fourth quarter of 2026.

#amgen #dazodalibep #sjogrens-disease #cd40l #phase-3 #non-peptide

Industry

Novartis Licenses Preclinical Radioligand Therapy from Suzhou-Based BoomRay in Deal Worth Up to $900 Million

BoomRay Pharmaceuticals, a radioligand developer based in Suzhou, China, said on September 22, 2026 that Novartis took an exclusive worldwide license to an undisclosed preclinical radioligand therapy asset. BoomRay can receive up to $900 million, including an upfront payment and development, regulatory, and sales milestones, plus royalties on net sales; the upfront amount, target, isotope, and indication were not disclosed. Novartis global oncology head Shiva Malek said the asset complements the company's radioligand portfolio, which includes the peptide-based Lutathera and the PSMA-targeted Pluvicto. The license was announced one day after the Telix–ITM merger.

#novartis #boomray #radioligand #licensing-deal

Clinical Trials

Immunovant Stops Cutaneous Lupus Development After FcRn Inhibitor IMVT-1402 Misses Week-12 Primary Endpoint

Immunovant, a majority-owned Roivant subsidiary, reported on September 23, 2026 that a 57-patient randomized, double-blind, placebo-controlled proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus did not reach statistical significance on percent change in CLASI-A score at week 12. The company reported numerical trends favoring the drug and an association between deeper IgG reductions and clinical response, but said the results did not meet its internal bar and it will stop development in the indication. Trials of the FcRn inhibitor continue in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, CIDP, and Sjögren's disease.

#immunovant #roivant #imvt-1402 #fcrn-inhibitor #lupus #non-peptide