Sanofi, AstraZeneca, Avillion and Diadem recently announced clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.
In recent months, the biotech and biopharma industries have been struggling with layoffs and dropping stocks. However, some companies are still experiencing success. Sanofi, AstraZeneca, Avillion and Diadem have recently announced positive clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.
Sanofi’s Sarclisa Scores in Multipe Myeloma
Sanofi’s drug isatuximab, marketed under the brand name Sarclisa, showed positive results in a Stage III clinical trial. Sarclisa is a drug authorized in the U.S. for the treatment of patients with relapsed refractory multiple myeloma who have received 1–3 prior lines of therapy and in the European Union for patients with multiple myeloma who have received at least 1 prior therapy. Both of these indications are in combination with carfilzomib and dexamethasone. It is also approved in several countries, including the U.S. and E.U, in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received two or more prior therapies including lenalidomide and a proteasome inhibitor.
Sarclisa is a monoclonal antibody that targets the CD38 receptor on multiple myeloma cells. In the Phase III Ikema clinical trial, Sarclisa and its combination drugs improved patients’ median progression-free survival rate. When patients were treated with only carfilzomib dexamethasone, the median progression-free survival time was only 19.2 months. However, with Sarclisa and carfilzomib dexamethasone, the survival time went up to 35.7 months.
The combination of Sarclisa, carfilzomib and dexamethasone, according to a PFS analysis, showed an mPFS of 41.7 months for Sarclisa added to carfilzomib dexamethasone.
AstraZeneca and Avillion
AstraZeneca’s drug PT027 is a novel inhaled corticosteroid, and a fixed-dose combination of albuterol and budesonide, PT027, is designed to help patients with asthma. AstraZeneca is working with Avillion LLP, a drug development company, to help move the drug through regulatory approvals.
Avillion announced that PT027 showed positive results in its Phase III Mandala clinical trial. The data showed that PT027 reduces the risk of severe asthma attack exacerbation by 27% compared to albuterol alone. Patients also experienced an improvement in symptom control while using PT027.
The data is published in the New England Journal of Medicine, and it will be presented at the American Thoracic Society (ATS) 2022 International Conference.
Following the good news, Avillion said that it plans on filing a new drug application (NDA) with the FDA, as well as a new clinical trial.
“We have enjoyed an excellent collaboration with AstraZeneca, under which we have delivered these large and complex trials during a pandemic and have ongoing regulatory responsibility for the NDA filing,” said Allison Jeynes, MD, CEO at Avillion. “Furthermore, this partnership has recently expanded to include a new decentralized, randomised trial in patients with mild asthma, which is anticipated to kick off in the coming months.”
Diadem
Italy-based Diadem SpA shared exciting news about its AlzoSure Predict product, a blood test for Alzheimer’s disease. The blood test measures a patient’s levels of p53 protein, a protein associated with Alzheimer’s disease. By measuring the protein, AlzoSure can determine whether an individual has Alzheimer’s disease, as well as accurately predict whether patients who currently have no or very mild cognitive impairments will suffer from full-blown Alzheimer’s disease within the next six years.
The product was tested in a retrospective longitudinal study with 482 individuals aged 60 or older. The data from the study showed that AlzoSure’s blood biomarker test was more accurate than the Aβ-PET imaging scans, which are currently the main method used for diagnosing patients with Alzheimer’s disease and giving them a prognosis for how quickly the disease will progress.
The results from the clinical study on AlzoSure are being published in the Journal of Prevention of Alzheimer’s Disease. The article is titled, “A Conformational Variant of p53 (U-p53AZ) as Blood-Based Biomarker for the Prediction of the Onset of Symptomatic Alzheimer’s Disease.”
AlzoSure recently received an FDA Breakthrough Device Designation and an CE-IVD marking for the EU.
