Clinical Trial News
Celltrion Pursues Adalimumab Interchangeability as Formycon Reports Positive Ustekinumab Biosimilar Data
- Celltrion Healthcare has filed an investigational new drug application with the FDA for a Phase 3 clinical trial to establish interchangeability of its adalimumab biosimilar, Yuflyma, with Humira.
- The Phase 3 trial will involve switching patients between Humira and Yuflyma to verify pharmacokinetics, efficacy, and safety in 366 patients with plaque psoriasis.
- Formycon announced positive Phase 3 data for its ustekinumab biosimilar (FYB202), demonstrating comparable efficacy and safety to Stelara in patients with moderate to severe plaque psoriasis.
- The Formycon study met its primary endpoint, showing comparable improvement in Psoriasis Area and Severity Index scores after 12 weeks, with no clinically meaningful differences in adverse events.
Cambridge Researchers Successfully Convert Kidney Blood Types to Universal O, Potentially Expanding Transplant Access
- University of Cambridge researchers successfully converted three donor kidneys from blood type B to universal type O using an enzyme-based perfusion technique that removes blood type markers from organ vessels.
- The breakthrough could significantly increase kidney transplant availability, particularly benefiting minority ethnic groups who face longer wait times due to blood type compatibility issues and lower donation rates.
- The conversion process takes only a few hours using a normothermic perfusion machine, with researchers now testing how the modified kidneys react to different blood types before clinical trials.
- Current data shows minority ethnic patients comprise 33% of the kidney transplant waiting list but only 9% of organ donations come from these communities, highlighting the potential impact of this technology.
FDA Approves Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes
The FDA has approved Inqovi™, an oral fixed-dose combination of decitabine and cedazuridine, for the treatment of adult patients with myelodysplastic syndromes (MDS). This approval is based on clinical trials demonstrating the drug's effectiveness and safety, offering a new oral treatment option for MDS patients.
Highlighted Clinical Trials:
Astex Pharmaceuticals, Inc.
Posted 10/28/2014
Astex Pharmaceuticals, Inc.
Posted 2/15/2018
Positive Results from B-Clear Phase IIb Trial for Bepirovirsen in Chronic Hepatitis B Treatment
GSK plc announced promising results from the B-Clear phase IIb trial of bepirovirsen, showing potential for functional cure in chronic hepatitis B patients. The trial demonstrated sustained clearance of hepatitis B surface antigen and HBV DNA, with a Phase III trial set to begin in H1 2023.
Pfizer and Valneva's Lyme Disease Vaccine Candidate Enters Phase 3 Trial
- Pfizer and Valneva have initiated a Phase 3 clinical trial for their Lyme disease vaccine candidate, VLA15, in areas highly endemic for the disease.
- The VLA15 vaccine aims to protect individuals as young as five years old and targets an outer surface protein of the Borrelia bacteria.
- This trial includes approximately 6,000 participants in the U.S. and Europe and could lead to regulatory authorization as early as 2025.
- The vaccine is similar to the previous LYMERix vaccine but omits a protein region that some attributed to adverse events.
Metformin Trial Targeting Aging Awaits Funding Despite Billionaire Interest in Longevity
- The TAME trial aims to demonstrate that metformin, a drug approved for diabetes, can delay multiple age-related diseases like cardiovascular disease, cancer, and cognitive decline.
- Nir Barzilai's TAME trial received FDA agreement in 2015 but has struggled to secure the $30-50 million needed, as philanthropists favor 'moonshot' projects over repurposing generic drugs.
- Experts believe the TAME trial could establish a framework for biotech companies, proving that targeting aging is a viable strategy for preventing multiple diseases simultaneously.
- Barzilai is now seeking funding from crypto-millionaires and Hevolution, hoping to launch the trial and establish aging as an indication for drug approval.
Tagrisso Plus Savolitinib Shows Promising 49% Response Rate in EGFR-Mutated Lung Cancer with MET Resistance
- Preliminary results from the SAVANNAH Phase II trial demonstrated that Tagrisso (osimertinib) plus savolitinib achieved a 49% objective response rate in EGFR-mutated NSCLC patients with high levels of MET overexpression who progressed on Tagrisso.
- MET was identified as the most common resistance biomarker in EGFR-mutated lung cancer, with 62% of patients screened showing MET overexpression and/or amplification after progression on Tagrisso.
- The combination therapy showed the highest response rate (52%) in patients with high MET levels who had not received prior chemotherapy, potentially offering a less toxic alternative to the current standard of chemotherapy after targeted therapy failure.
BellaSeno Initiates Clinical Trials for Resorbable Breast and Chest Implants
BellaSeno GmbH has launched two clinical trials in Australia for its resorbable implants aimed at treating pectus excavatum and for breast implant revision or congenital defect correction. The trials involve porous polycaprolactone implants that are absorbed by the body over time, leaving behind natural tissue.
Efficacy and Safety of Anlotinib in Extensive-Stage Small Cell Lung Cancer
A study involving 202 patients with extensive-stage small cell lung cancer (ES-SCLC) evaluated the efficacy and safety of anlotinib, either alone or in combination with other treatments. The median progression-free survival (PFS) was 4.8 months, and the median overall survival (OS) was 7.6 months. Combination therapy showed superior outcomes compared to monotherapy, with a median PFS of 6.0 months and a median OS of 9.2 months. The study highlights the potential of anlotinib as a treatment option for ES-SCLC, especially in combination with other therapies.
Genetic Variations in Serotonin Receptors Influence Psychedelic Drug Potency
- A new study identifies that genetic variations in serotonin (5-HT2A) receptors may alter the potency of psychedelic drugs, impacting individual responses.
- Researchers found that different gene forms of the 5-HT2A receptor exhibit significant differences in drug potency when binding to psychedelics like psilocin and mescaline.
- The study suggests that genetic factors should be considered in future clinical trials evaluating the therapeutic potential of psychedelic drugs for psychiatric applications.
- These findings may help explain the wide range of responses observed in patients treated with psychedelics, with some experiencing significant benefits and others none.