Clinical Trials Round-Up: March and April 2026

Welcome to the second edition of the pharmaphorum Clinical Trials Round-Up for 2026.

March and April offered no shortage of talking points for the clinical trials community. Promising oncology data, mixed results in immunology, and fresh evidence in metabolic disease all competed for attention.

While you may have seen headlines covering big name studies like, Novo Nordisk’s first data for 'triple G' agonist in diabetes, Sanofi’s mixed Phase 2 findings for its bispecific antibody lunsekimig, or AstraZeneca’s encouraging tozorakimab results in COPD, as well as renewed debate around transparency and reporting standards, alongside financial efforts to strengthen clinical research in the UK – it would be impossible for us to cover each and every trial update that hits our inbox every day.

So, to highlight prominent developments, we have collated this edition of our bimonthly clinical trial round-up to fill in the gaps you may have missed in our news headlines.

Immunology and dermatology

Fresh long-term data boosted the case for Affibody’s izokibep in hidradenitis suppurativa (HS) in March. Building on previously reported positive topline findings, 32-week Phase 3 results showed that patients who remained on treatment maintained their responses, while those who switched from placebo also experienced meaningful clinical improvements. No new safety signals emerged during extended follow-up.

Long-term disease control was also a key theme for Almirall, which presented long-term interim findings from the Phase 3b ADlong study of lebrikizumab in moderate-to-severe atopic dermatitis. Results from the open-label extension study showed that the drug delivered near-complete skin clearance and itch relief for up to four years for patients with moderate-to-severe atopic dermatitis, with 94% of patients achieved EASI-75, 75% achieved EASI-90, and 78% reported meaningful itch relief.

In autoimmune disease, Imviva Biotech announced the acceptance of a late-breaking presentation featuring data from its ongoing Phase 1/2 study of CTA313, a CD19/BCMA dual-targeted allogeneic CAR-T therapy in systemic lupus erythematosus. The company reported durable remissions and evidence supporting an immune-reset mechanism, with repopulation by healthy naïve B-cells following treatment.

Neurology and CNS disorders

Efforts to address excessive daytime sleepiness in narcolepsy also moved forward during March and April. Eisai kicked off preparations for a global Phase 2 study of E2086, a selective orexin-2 receptor agonist that has already demonstrated statistically significant improvements in wake time in a proof-of-mechanism study in patients with narcolepsy type 1. The new study will evaluate three dose levels against placebo using both objective and patient-reported measures of wakefulness. Study sites are planned for Canada, China, Europe, Japan, and South Korea.

In Parkinson’s disease, new analyses from Integrative Research Laboratories Sweden AB’s Phase 2b REACT-PD study of pirepemat, presented at the AD/PD 2026 International Conference in March, highlighted a potential dose-dependent effect on fall reduction. While the overall study did not achieve statistically significant reductions at the highest dose tested, pharmacokinetic analyses suggested a U-shaped exposure-response relationship, with patients in the mid-exposure range achieving a statistically significant 31% reduction in falls compared with placebo.

In April, Rapport Therapeutics unveiled follow-up data from its Phase 2a trial of RAP-219 in focal onset seizures at the 2026 American Academy of Neurology Annual Meeting. Study results showed that patients maintained clinically meaningful reductions in seizure activity during the eight-week follow-up period after treatment cessation, supported by the drug’s approximately 22-day half-life. Moreover, median clinical seizure reductions reached 90% during weeks 9-12 and 59% during weeks 13-16 relative to baseline. Two Phase 3 studies are expected to begin during the second quarter of 2026.

Nxera Pharma announced that partner Neurocrine Biosciences had dosed the first patient in a Phase 2 schizophrenia trial evaluating NBI-1117570, an oral dual muscarinic M1/M4 receptor agonist discovered under the companies’ collaboration.

Meanwhile, Exciva also reached an important development milestone, dosing the first patient in the Phase 2/3 SERENADA study evaluating Deraphan for agitation associated with Alzheimer’s disease dementia. The global trial aims to enrol approximately 300 participants across up to 60 centres and will assess the impact of treatment on agitation symptoms over six weeks.

Oncology

In March, IMUNON reported updated Phase 2 data from the OVATION 2 study of IMNN-001 in newly diagnosed advanced ovarian cancer. Final analysis showed the median overall survival benefit increased from the previously reported 11.1 months to 14.7 months. Patients who also received PARP inhibitor therapy demonstrated a median overall survival improvement of 24.2 months. The company also noted that enrolment in its Phase 3 programme remains ahead of plan.

Biotech company Transgene completed patient randomisation in the Phase 2 portion of its Phase 1/2 TG4050 study in HPV-negative head and neck cancer in April. According to the company, 38 patients have been randomised, with the primary endpoint of two-year disease-free survival expected to read out by the end of the first quarter of 2028. The announcement follows encouraging Phase 1 findings that showed all treated patients remained disease-free at two years.

Also in April, Theolytics announced dosing of the first patient in OCTOPOD-IP, a US-based Phase I trial evaluating intraperitoneal administration of THEO-260 in platinum-resistant ovarian cancer. THEO-260 is designed to target both cancer cells and cancer-associated fibroblasts while stimulating immune activation. This US study is the second clinical trial investigating THEO-260 in this indication, the first being the ongoing OCTOPOD-IV Phase 1/2a trial, which is currently recruiting across the UK, Spain, and Canada.

Elsewhere, Kainova Therapeutics expanded its DOMISOL Phase 1/2 study of DT-7012 into Europe, dosing the first patient in France. This dosing follows the initiation of the DOMISOL Phase 1/2 study in Australia, which was announced in October 2025. DT-7012 is a Treg-depleting anti-CCR8 monoclonal antibody being evaluated as both monotherapy and in combination with pembrolizumab for advanced solid tumours.

Bicycle Therapeutics provided updates on nuzefatide pevedotin, reporting encouraging Phase I combination data with nivolumab in metastatic urothelial cancer and announcing dosing of the first patient in a Phase 2 trial in previously treated pancreatic ductal adenocarcinoma. The company identified 8 mg/m² every two weeks as its preferred monotherapy dose moving forward.

SalubrisBio presented Phase 1/2 data for JK06, its 5T4-targeted antibody-drug conjugate at the American Association for Cancer Research Annual Meeting. Among 112 safety-evaluable patients in expansion cohorts, results showed that treatment was generally well tolerated, with only three Grade 3 treatment-related adverse events reported and no Grade 4 or Grade 5 events observed. The ongoing study continues to evaluate safety and preliminary efficacy across advanced solid tumours.

Ophthalmology and gene therapy

In March, NovaBridge and Visara reported positive Phase 2a results for VIS-101 in wet age-related macular degeneration. The dual VEGF-A and ANG-2 inhibitor delivered mean visual acuity improvements exceeding 10 ETDRS letters and substantial reductions in central retinal thickness, while demonstrating favourable safety and durability. A Phase 2b study is expected to begin in the second half of 2026.

Then, in April, Aurion Biotech announced first-patient dosing in the pivotal Phase 3 ASTRA study of AURN001 for corneal oedema secondary to corneal endothelial dysfunction. The regenerative cell therapy combines cultured human corneal endothelial cells with a rho-kinase inhibitor and is being evaluated across 12 US sites, with the primary endpoint being the proportion of patients achieving a 15-letter improvement in best corrected visual acuity at six months.

Elsewhere, AAVantgarde advanced its inherited retinal disease programme, announcing upcoming presentations of preliminary Phase 1/2 LUCE-1 data in Usher syndrome type 1B. The study has enrolled 15 participants and evaluates AAVB-081, a dual-vector gene therapy designed to deliver the full MYO7A gene, which is too large for conventional AAV approaches.

1. Clinical pipelines continue to advance into the next stage of development

A notable number of companies reported first-patient dosing milestones during the period, including trials from Aurion Biotech, Nxera Pharma, Exciva, Theolytics, Kainova Therapeutics, CatalYm, Atrogi, and Elevara. The breadth of indications represented – from schizophrenia and Alzheimer's disease to ovarian cancer and rheumatoid arthritis – underscores continued investment in expanding clinical pipelines and generating proof-of-concept data across diverse therapeutic areas.

2. Immunology programmes delivered some of the strongest late-stage data

Several of the most mature datasets reported during March and April came from immunology and inflammatory disease programmes. Affibody's izokibep demonstrated durable responses in hidradenitis suppurativa, while Almirall reported up to four years of sustained efficacy with lebrikizumab in atopic dermatitis. The results reinforce the growing role of targeted biologics in chronic inflammatory diseases.

3. Novel cell and gene therapies continue to broaden beyond traditional oncology applications

While oncology remains a major focus, advanced therapeutic approaches are increasingly being explored in other disease areas. Imviva's allogeneic CAR-T programme in systemic lupus erythematosus reported evidence of durable remission and immune reset, while AAVantgarde and Aurion advanced gene and regenerative cell therapy programmes targeting inherited retinal disease and corneal endothelial dysfunction respectively.

4. Oncology innovation remains highly diverse

The oncology updates highlighted a wide range of therapeutic approaches, from personalised cancer vaccines and oncolytic immunotherapies to antibody-drug conjugates, Treg-depleting antibodies, and next-generation immunotherapies. The variety of mechanisms entering or progressing through clinical development reflects continued efforts to improve outcomes in difficult-to-treat solid tumours and haematological malignancies.

5. Companies are increasingly focusing on durability and long-term outcomes

Many of the most notable updates focused on durability. Long-term follow-up data from programmes, including lebrikizumab, izokibep, RAP-219, and IMNN-001, highlighted sustained efficacy over extended periods, while several studies emphasised progression into pivotal development based on accumulating evidence of durable clinical activity.

^{Editor’s note: This round‑up is based on press releases, peer‑reviewed publications, and company communications received in March and April 2026. All results are preliminary unless stated, and many programmes are early‑phase or subject to further validation in controlled studies.}