November 2025 • PharmaTimes Magazine • 9
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Ultra-rapid insulin shows promise in phase 3 trial for type 1 diabetes
Adocia and Tonghua Dongbao have announced positive topline results from a phase 3 clinical trial of BioChaperone Lispro (THDB0206 injection), an ultra-rapid insulin formulation, in adults with type 1 diabetes.
The trial, conducted in China and approved by the Chinese Regulatory Authorities, compared THDB0206 injection with standard of care Humalog. A total of 550 adults with inadequate glycaemic control were enrolled, all using multiple daily insulin injections.
After 26 weeks, the study met its primary endpoint, showing non-inferior HbA1c reduction compared to Humalog.
The key secondary endpoint was also achieved, with a statistically significant lower rise in blood glucose after a standard meal for the THDB0206 group. Additional data revealed improved blood glucose levels two hours post-meal and a consistent reduction one hour after each meal, based on 10-point self-monitoring blood glucose (SMBG).
Mr Li, President of Tonghua Dongbao, said: “We are delighted with the positive results from this phase 3 clinical trial, which confirm the benefits of THDB0206 injection for improving blood glucose control of adults with type 1 diabetes. Tonghua Dongbao is committed to continue to innovate in the treatment of diabetes and obesity.”
Olivier Soula, CEO and Co-Founder of Adocia, explained: “We are extremely proud of the phase 3 results achieved in both type 1 and type 2 diabetes: for both populations, we succeeded in improving postprandial blood glucose control after each meal compared to the standard of care.”
New treatment option for endometriosis approved in Scotland
Women in Scotland suffering from endometriosis now have access to a new treatment option following the Scottish Medicines Consortium’s (SMC) acceptance of linzagolix with add-back therapy (ABT).
The once-daily pill is approved for adult women of reproductive age who have previously undergone medical or surgical treatment for the condition.
The decision aligns NHS Scotland with the rest of the UK, where linzagolix has already been approved by the National Institute for Health and Care Excellence (NICE) for use in England, Wales and Northern Ireland.
Endometriosis affects around one in ten women of reproductive age in the UK and can cause chronic pelvic pain, painful menstruation and significant impacts on quality of life.
Dr Lucky Saraswat, Consultant Gynaecologist and Honorary Senior Lecturer at the University of Aberdeen, explained: “As the need for more individualised approaches to endometriosis management becomes increasingly clear, the availability of an additional therapeutic option represents an important advance.
“It is encouraging to see women in Scotland gaining access to new treatment options, and I hope ongoing research will continue to broaden the choices available.”
Sandy Lindsey, UK General Manager at Theramex, said: “There are too many women who are living with pain due to their endometriosis. With the SMC approval of linzagolix we can now offer an additional treatment option to women in Scotland, empowering clinicians and patients with more choices.”
HOT & NOT
Xeltis has announced successful results from its aXess EU phase 3 trial, confirming the potential of its restorative vascular access conduit for patients undergoing heamodialysis. The multicentre study met its primary endpoint and showed major improvements compared to standard of care.
Conducted across 18 EU sites, the trial involved 120 patients with end-stage renal disease. Many had previously experienced failed grafts or fistulas or relied on central venous catheters.
aXess demonstrated superior sustained patency, fewer interventions and high infection resistance.
Three new studies have launched in Manchester to evaluate the effectiveness of vaccines for severe acute respiratory infections. The trials are the first to be delivered by the Greater Manchester Commercial Research Delivery Centre, supported by the National Institute for Health and Care Research.
The studies aim to recruit 300 patients hospitalised with severe acute respiratory infections during the winter season.
They will then assess how COVID-19 and respiratory syncytial virus vaccines perform outside clinical trials and throughout the diverse populations.
Sheffield Teaching Hospitals NHS Foundation Trust has become the UK’s sole centre for a pioneering international research trial that could transform treatment for patients with a rare and life-limiting autoimmune condition.
The trial – named UPSIDE – is the first to investigate whether autologous haematopoietic stem cell transplantation should be offered as a first-line treatment for diffuse cutaneous systemic sclerosis, a severe form of scleroderma.
Acella Pharmaceuticals and Neuvosyn Laboratories have announced positive topline results from a phase 2 clinical trial of North Star, an investigational desiccated thyroid extract (DTE) for hypothyroidism.
The study met its primary endpoint, successfully defining the dose conversion ratio between levothyroxine and North Star. The trial also demonstrated a favourable safety profile. Conducted under the investigational name North Star, the study was led by Acella through its sister company Neuvosyn Laboratories.
Eli Lilly and leading Alzheimer’s disease experts have called for urgent investment in diagnostic infrastructure across Europe, following new findings presented at the Alzheimer Europe Conference in Belgium.
The data, drawn from the Adelphi Real World Dementia Disease Specific Programme, highlights widespread underdiagnosis of Alzheimer’s disease (AD), with fewer than one in five patients receiving biomarker testing to confirm pathology.
New NHS league tables have revealed that 80 percent of England’s 134 acute hospital Trusts are considered to be failing, either due to missing performance targets or running financial deficits. Experts have warned that ranking providers may oversimplify complex healthcare challenges.
Meanwhile, reports suggest that UK drug prices could rise significantly due to pressure from the US government, potentially costing the NHS billions.
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