On August 28, 2024, PharmaDrug Inc., a specialty pharmaceutical company focused on the research, development, and commercialization of controlled substances and natural medicines, announced strategic plans to advance the clinical development of its patented enteric-coated Cepharanthine formulation (PD-001) for viral infectious diseases. Following approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study for PD-001, PharmaDrug aims to further develop this potential treatment through pharmaceutical partnerships or government support, including engagement with organizations such as the Biomedical Advanced Research and Development Authority.
CEO Robert Steen expressed enthusiasm for progressing PD-001 as an anti-viral treatment, noting its potential to address a wide range of viral infectious diseases. Cepharanthine, the key component in PD-001, has demonstrated efficacy against several viruses including Ebola, SARS/COVID, and Zika. However, its bioavailability has been a limiting factor. PD-001, with its enhanced bioavailability, offers promising prospects as a multi-indication anti-viral therapy.
Cepharanthine, an approved drug in Japan, has shown antiviral activity against various viruses. However, its low oral bioavailability has hindered its therapeutic potential. PD-001 addresses this limitation through improved solubility and bioavailability, positioning it as a viable candidate for antiviral therapy. Protected by US Patent US10576077, PD-001 offers significant advancements in the treatment of viral infectious diseases.
PharmaDrug’s subsidiary, Sairiyo Therapeutics, is spearheading the clinical development of PD-001. By leveraging its expertise in reformulating natural medicines and conducting clinical trials, the company aims to bring PD-001 to market for infectious disease and oncology applications. The company also holds interests in synthetic drug development through SecureDose Synthetics Inc.
PharmaDrug stresses that the efficacy of cepharanthine in treating infectious diseases remains under investigation and does not make direct claims regarding treatment outcomes. The company emphasizes the importance of regulatory compliance and transparent communication regarding its product development.
For more information, the original press release can be accessed at the source: https://www.newsfilecorp.com/release/221285.