October 2024 • PharmaTimes Magazine • 9
// CONDITIONS //
Centessa reports positive phase 1 clinical data for ORX750
Nxera Pharma, formerly known as Sosei Group, has announced that its partner, Centessa Pharmaceuticals, has reported encouraging interim results from a phase 1 clinical trial of ORX750.
The novel orexin receptor 2 (OX2R) agonist was tested in acutely sleep-deprived healthy volunteers.
The trial revealed that ORX750 significantly improved mean sleep latency at doses of 1.0mg and 2.5mg, as measured by the Maintenance of Wakefulness Test (MWT), compared to a placebo. Notably, the 2.5mg dose restored normative wakefulness with a mean sleep latency of 32 minutes.
Safety and tolerability were also strong points for ORX750, with no frequently reported adverse events typically associated with other OX2R agonists. Additionally, there were no cases of hepatotoxicity or visual disturbances across all tested doses (1.0mg, 2.0mg and 2.5mg).
Given these promising results, Centessa plans to advance ORX750 into Phase 2 studies targeting patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) starting in the fourth quarter of 2024.
Nxera will update stakeholders on any milestone events that trigger material payments from Centessa.
This development represents a significant advancement in the treatment of sleep-wake disorders, potentially improving the quality of life for those affected by narcolepsy and related conditions.
Acelyrin’s izokibep for hidradenitis suppurativa reveals positive results
Acelyrin has shared positive results from a late-stage study of its IL-17A inhibitor izokibep in hidradenitis suppurativa (HS), but has said it will not be moving forward with the asset in this indication.
Estimated to affect about 1% of the population in most studied countries, HS is a chronic inflammatory skin condition that causes painful nodules and abscesses.
In the phase 3 trial, izokibep demonstrated statistically significant responses across multiple efficacy endpoints at week 12, with 33% of patients being treated with izokibep 160mg weekly achieving at least a 75% reduction in total abscess and inflammatory nodule count (HiSCR75) compared to 21% of those receiving placebo.
Results also showed that 25% and 22% of izokibep-treated patients achieved HiSCR90 and HiSCR100, respectively, compared to 9% and 8% in the placebo cohort.
The announcement comes shortly after the drug demonstrated promising results in a phase 2b/3 study for psoriatic arthritis (PsA), a chronic inflammatory disease characterised by joint pain, stiffness and swelling.
Acelyrin said it will complete the ongoing HS and PsA trials, but will suspend new investment in these indications. A phase 2b/3 trial of izokibep in uveitis will also continue through its primary endpoint, with top-line data expected later this year.
The company outlined that it will now be prioritising the development of lonigutamab, an anti-IGF-1R monoclonal antibody being evaluated as a treatment for thyroid eye disease.
HOT & NOT
AMLo Biosciences has announced the successful receipt of the UKCA mark for AMBLor – a groundbreaking histopathological biomarker test for identifying early-stage melanomas at low risk of progression. This in vitro diagnostic (IVD) test can reliably stratify non-ulcerated AJCC stage I-II melanomas, potentially sparing patients from further diagnostic procedures and lengthy follow-up schedules. The UKCA label allows AMBLor to be marketed in Great Britain, making it available to healthcare professionals.
Vivet Therapeutics, a clinical-stage biotech company developing novel gene therapies for rare liver metabolic disorders, has announced that the European Commission has granted orphan drug designation to VTX-806, its gene therapy product for the treatment of cerebrotendinous xanthomatosis.
Preclinical studies of VTX-806, an adeno-associated viral vector encoding human CYP27A1, showed a reduction of hepatomegaly in mice and normalisation of compensatory enzymes and bile acids compared to current treatments.
Serac Healthcare, a clinical radiopharmaceutical company, and the University of Exeter have announced the commencement of a phase 2 study involving a novel molecular SPECT imaging agent, 99mTc-maraciclatide.
This study, named ‘PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT (PREDICT-ILD)’, has successfully scanned its first patient.
The main study aims to assess the effectiveness of quantitative computed tomography in detecting the progression of interstitial lung disease.
The chatbot ChatGPT performed better than trainee doctors in assessing complex cases of respiratory disease in areas such as cystic fibrosis, asthma and chest infections, according to a study presented at the European Respiratory Society (ERS) Congress in Vienna, Austria.
The study also showed that Google’s chatbot Bard performed better than trainees in some aspects, and Microsoft’s Bing chatbot performed as well as trainees.
The charity Prostate Cancer Research has launched a national campaign, calling for a screening programme to improve survival rates and quality of life for men in the UK.
The ‘Proactive For Your Prostate’ campaign is calling for recent advances in prostate cancer diagnosis to be utilised at a national level and an end to health inequity for men.
A petition signed by over 135,000 people has been delivered to Downing Street, calling for urgent action from the government to implement a national screening programme for prostate cancer.
World Sepsis Day aims to raise awareness about sepsis, a life-threatening condition that claims millions of lives each year.
The condition results from a dysregulated immune response to infection, and currently, no drugs specifically target its underlying causes. GlobalData, a leading data and analytics company, stresses the need for improved clinical trial designs and targeted therapies to address this gap.
According to GlobalData, 14 drugs are in late-stage development for sepsis across eight major markets.
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