Boston, USA - 6 November 2023 - Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities, today released the latest 2023 global clinical trial landscape reports on Primary Biliary Cholangitis (PBC) and Hemophilia.
The Novotech research analyst team offers these expert reports monthly at no cost.
These reports provide up-to-date information on global clinical trial activity, shedding light on the regions that are witnessing the highest trial numbers and the reasons behind it. It also addresses the challenges confronting biotech companies in these specific therapeutic domains and the future directions in therapy and investment trends.
As per the findings in the Primary Biliary Cholangitis – Global Clinical Trial Landscape report there have been approximately 140 active clinical trials focused on PBC since 2018.
PBC is a persistent inflammatory hepatobiliary condition distinguished by the destruction of interlobular bile ducts mediated by T-cell lymphocytes. When not appropriately managed, it may progress to biliary cirrhosis and eventual liver failure.
The report offers the most recent data including:
- The United States and China lead in venture funding for PBC research and 2023 has seen a significant investment increase.
- The Asia-Pacific region, particularly Mainland China, has a substantial presence in PBC clinical trials. The United States, the United Kingdom, and France are also attractive locations.
- PBC predominantly affects women, with more than 90% of patients being female. It is typically diagnosed between the ages of 30 and 40.
- Several potential future therapies for PBC are being explored, including peroxisome proliferator-activated receptor and FXR agonists are being considered for disease-modifying therapies due to their potential to improve liver fibrosis. Additionally, ongoing investigations are exploring the potential of fibroblast growth factor-19 agonists and NOX inhibitors.
- Current research drug superiority remains unclear, necessitating extended clinical studies and deeper research into PBC's mechanisms for fresh treatment approaches.
In the Hemophilia Global Clinical Trial Landscape report, there has been a substantial increase in global clinical trials aimed at advancing hemophilia treatment since 2018. A significant emphasis has been placed on the Asia-Pacific region, particularly in Mainland China and Japan.
These regions have developed into strong research centers, equipped with cutting-edge facilities, bolstered by accommodating regulatory structures.
The report discoveries include:
- European single-country trials have demonstrated remarkable efficiency with shorter recruitment durations, highlighting their commitment to enhancing patient care through clinical studies.
- There were 233,577 identified cases of hemophilia worldwide according the 2021 Global Survey by the World Federation of Hemophilia (WFH).
- Hemophilia A accounted for the majority of cases, with 185,318 reported cases, while Hemophilia B represented 37,998 cases.
- Emerging therapies for the treatment of hemophilia including phase III gene therapies that use Adeno-associated Virus (AAV) vectors to provide long-term and potentially curative treatment for hemophilia patients. Bispecific monoclonal antibodies, small interfering RNA (siRNA) therapies, and cell-based therapies are also under investigation.
Novotech has more than 3,000 employees operating across 25 geographies, with 34 office locations, including the US, Greater China, South Korea, Australia, New Zealand, and Europe.
The CRO offers biotechs a unique and unparalleled suite of early to late-phase services across the US and Europe, with a foundation in Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.
Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023 and the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2022 award. Additionally, the company was honored with the Asia-Pacific Contract Research Organization Company of the Year Award. Its commitment to collaboration is evident in the 50 Leading Site Partnership agreements it has signed over the past three years.
Novotech is internationally recognized as the leading Asia Pacific centred Biotech Contract Research Organization (CRO) with global execution capabilities.
Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 3000 staff globally and 34 office locations.
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