Clinical Trial News
Persist AI Secures $12M Series A Funding to Revolutionize Pharmaceutical Formulation Development
• Persist AI has raised $12 million in Series A funding led by Spero Ventures to expand its AI-driven robotic laboratory for pharmaceutical formulation development.
• The company's newly launched Cloud Lab platform enables pharmaceutical companies to remotely develop and test drug formulations, reducing traditional timelines from a year to just two months.
• Persist AI's technology supports various drug modalities including peptides, small molecules, and antibodies, with plans to build a GMP manufacturing system for long-acting injectables in collaboration with Nivagen Pharmaceuticals.
Kriya Therapeutics Presents Promising Preclinical Data for KRIYA-825 Gene Therapy in Geographic Atrophy
• Kriya Therapeutics presented preclinical data for KRIYA-825, a one-time gene therapy delivered via suprachoroidal injection, showing dose-dependent preservation of retinal thickness in mouse models of Geographic Atrophy.
• KRIYA-825 expresses a CR2-CR1 fusion protein designed to inhibit complement C3 and C5 activity, targeting validated therapeutic pathways already approved by the FDA for Geographic Atrophy treatment.
• The therapy aims to provide multi-year durability through AAV-mediated continuous protein expression, potentially eliminating the need for frequent intravitreal injections required by current GA treatments.
UCB and Domino Data Lab Partner to Modernize Statistical Computing for Accelerated Drug Development
• UCB and Domino Data Lab have announced a strategic collaboration to transform legacy Statistical Computing Environments into unified, cloud-enabled platforms that integrate diverse analytical tools like SAS, R, and Python.
• The modernized environment will embed critical metadata and workflow management capabilities, enabling searchable data re-use while maintaining compliance with industry standards such as GxP, FDA 21 CFR Part 11, and GDPR.
• This partnership aims to expedite the development of differentiated therapies for severe diseases by enhancing research capabilities, enabling more efficient clinical studies, and leveraging large-scale data analysis for improved efficacy predictions.
NASA Awards Phase II Contract to Yank Technologies for Lunar Power Transmission Innovation
• Yank Technologies has secured a two-year NASA SBIR Phase II contract to advance their Dust-Tolerant Resonant Connectors for power transmission on lunar and planetary surfaces.
• The technology features completely insulated interlocking coils with no exposed conductive terminals, designed specifically to withstand the harsh, dusty environments of the Moon and Mars.
• The Phase II development will optimize size, weight, and power capabilities for kilowatt applications, with verification using lunar and planetary regolith for integration into upcoming NASA missions.
Arineta's SpotLight Duo CT Scanner Receives FDA Clearance for Lung Cancer Screening
• Arineta's SpotLight Duo cardiac CT scanner has received FDA 510(k) clearance for low-dose lung cancer screening, enabling a single platform for both cardiac and lung imaging.
• The ultra-fast scanner captures the entire heart in a single beat with 140mm coverage and 0.24-second rotation speed, utilizing deep-learning image reconstruction technology for enhanced diagnostic accuracy.
• This regulatory milestone expands access to critical screening for lung cancer, the leading cause of cancer deaths in the U.S., potentially improving outcomes for high-risk patients across various healthcare settings.
FDA's Approval of MRD as End Point Transforms Multiple Myeloma Research and Treatment
• The FDA's Oncology Drugs Advisory Committee unanimously approved minimal residual disease (MRD) as an end point for accelerated approval of multiple myeloma therapies in April 2024, potentially reducing trial timelines from 10-15 years to just 3 years.
• Pharmaceutical companies have rapidly adapted by implementing MRD as a coprimary end point in new trials and amending existing protocols, with the CEPHEUS trial being the first major study to read out with MRD as a coprimary endpoint.
• Researchers are now exploring MRD applications beyond drug approval, including using MRD status to guide treatment decisions, developing improved blood-based detection technologies, and expanding the approach to other hematologic malignancies.
Highlighted Clinical Trials:
Janssen Research & Development, LLC
Posted 11/6/2018
Stichting European Myeloma Network
Posted 12/14/2018
University of Miami
Posted 2/11/2020
K2 Medical Research Launches New Clinical Trials Program in Rhode Island Focusing on Alzheimer's Disease
• K2 Medical Research has established a new clinical trials facility in East Providence, Rhode Island, bringing innovative research opportunities to Southern New England with a primary focus on Alzheimer's disease.
• The East Providence site is currently enrolling participants for two Alzheimer's disease studies targeting different stages of the condition, as well as a study for alcohol use disorder.
• According to the Alzheimer's Association 2025 data, over 7 million Americans are living with Alzheimer's disease, with approximately 22,000 affected in Rhode Island alone, highlighting the critical need for new treatments.
Ionis Reports Positive Phase 3 Results for Olezarsen in Hypertriglyceridemia
• Olezarsen demonstrated significant triglyceride reductions of 61% and 58% at 6 months with 80mg and 50mg monthly doses respectively in patients with moderate hypertriglyceridemia.
• The Phase 3 Essence study met all primary and secondary endpoints, with most participants achieving triglyceride levels within normal range despite already being on standard lipid-lowering therapies.
• Following recent FDA approval of olezarsen (Tryngolza) for familial chylomicronemia syndrome, these results support potential expanded indication for severe hypertriglyceridemia pending upcoming CORE and CORE2 trial data.
Highlighted Clinical Trials:
Ionis Pharmaceuticals, Inc.
Posted 11/21/2022
Ensifentrine Shows Promise as Novel Monotherapy and Add-On Treatment for COPD
• New data from the Phase 3 ENHANCE trials demonstrates that ensifentrine, a dual phosphodiesterase 3 and 4 inhibitor, significantly improves lung function and reduces exacerbations in COPD patients.
• Ensifentrine monotherapy showed meaningful improvements in patient-reported outcomes including dyspnea, COPD symptoms, and health-related quality of life compared to placebo in patients not on long-acting medications.
• As the first nebulized non-steroidal therapy with a novel dual mechanism of action, ensifentrine represents an important addition to the COPD treatment arsenal, offering benefits both as first-line and add-on therapy.
Highlighted Clinical Trials:
Verona Pharma plc
Posted 9/29/2020
Verona Pharma plc
Posted 9/22/2020
BATURA Trial: Airsupra Reduces Severe Asthma Exacerbation Risk by 47% Compared to Albuterol Alone
• AstraZeneca's Airsupra (albuterol/budesonide) demonstrated a 47% reduction in severe asthma exacerbation risk compared to albuterol alone in patients with mild asthma, according to the Phase IIIb BATURA trial.
• The anti-inflammatory rescue therapy reduced total systemic corticosteroid exposure by 63%, potentially decreasing risks associated with cumulative steroid use including diabetes, cardiovascular disease, and other adverse conditions.
• Results were so overwhelmingly positive that the Independent Data Monitoring Committee recommended early termination of the trial, suggesting a potential paradigm shift in asthma rescue treatment after 50 years of albuterol-only standard care.
Highlighted Clinical Trials:
AstraZeneca
Posted 5/20/2024
AstraZeneca
Posted 6/17/2024
Bond Avillion 2 Development LP
Posted 9/2/2022