Breye Therapeutics has reported promising early clinical findings for its lead oral therapy danegaptide, following a presentation at the Angiogenesis, Exudation and Degeneration 2026 symposium.

The data, presented by Prof Carl Regillo, detailed results from a phase 1b study involving 24 patients with non-proliferative diabetic retinopathy (NPDR) and associated macular oedema.

The multi-centre, open label trial, conducted across 11 sites in the UK, Germany and the US, assessed safety, tolerability, pharmacokinetics and early biological activity.
Danegaptide is described as a first-in-class oral small molecule designed to stabilise the vasculature and protect against retinal capillary breakdown and vascular leakage caused by hyperglycaemia.

According to Breye, the treatment was well tolerated and produced plasma levels within the targeted therapeutic range.

More than half of participants showed retinal imaging data consistent with reductions in vascular leakage, a key pathology in NPDR, and several patients demonstrated notable anatomical improvements after four weeks of treatment. By study end, a statistically significant reduction in oedema measures had been recorded.

These findings support Breye’s plans to initiate a phase 2 randomised clinical trial in NPDR, using improvements in Diabetic Retinopathy Severity Scale scores as the regulatory endpoint. The company is currently preparing for this next stage and is fundraising to support development.

Prof Regillo said: “The clinical data are encouraging and support the pursuit of danegaptide as an oral, non-invasive treatment solution. Danegaptide has the potential to be a medicine capable of treating diabetic retinopathy from its earlier, NPDR stages.

“This would create new options for how diabetic retinopathy is treated – opening the door to halting or even reversing disease and treating it before the risk emerges of disease progression to advanced forms. As an oral therapy, it would enable treatment intervention earlier than what is possible today.”

Corcept Therapeutics, a pharmaceutical company specialising in cortisol-modulating medications, has announced that its relacorilant plus nab-paclitaxel combination treatment has shown positive results in patients with platinum-resistant ovarian cancer.

The results were shown in the phase 3 ROSELLA trial. The trial found that patients receiving the combination treatment had a 35% reduction in risk of death compared with the group receiving only nab-paclitaxel.

Patients receiving combination treatment had a median overall survival (OS) of 16 months, while those receiving nab-paclitaxel alone had a median OS of 11.9 months.
The combination was found to have a favourable tolerability and safety profile, with comparable numbers of adverse events between the combination and monotherapy arms of the study.

This data builds on Corcept’s previous announcement of improved progression-free survival (PFS) rates in the ROSELLA trial. The trial found that patients treated with the combination therapy had a 30% reduction in risk of disease progression.
Complete results from the ROSELLA trial are expected to be presented at an upcoming medical meeting.

Ovarian cancer is the fifth leading cause of deaths from cancer in women. Many patients see their disease become either sensitive or resistant to platinum-containing chemotherapy, leaving them with limited therapeutic options.

Each year, in the US, around 20,000 women with platinum-resistant ovarian cancer and 13,000 women with platinum-sensitive ovarian cancer are candidates to begin new treatments, with the number of women in Europe equalling or exceeding this.

Alexander B Olawaiye, director of gynaecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and principal investigator in the ROSELLA trial, said: “ROSELLA’s findings compel us to evaluate relacorilant as a treatment for earlier stages of ovarian cancer and for other tumours that express the glucocorticoid receptor, such as endometrial and cervical cancer.”

Corcept is working to build a pipeline of cortisol-modulating treatments for severe endocrinologic, oncologic, metabolic and neurologic diseases.