Curanex Pharmaceuticals Announces IND-Enabling Studies for Phyto-N, botanical Drug candidate Targeting Ulcerative Colitis & Multiple Inflammatory Diseases
August 26, 2024 – Curanex Pharmaceuticals Inc. today announced its plans to advance its lead drug candidate, Phyto-N, a botanical extract, through the Food and Drug Administration (FDA) approval process. The company will initiate IND (Investigational New Drug) submission and subsequent Phase I clinical trials, initially focusing on moderate to severe ulcerative colitis.
Phyto-N is derived from a single plant and has demonstrated anti-inflammatory properties through multiple mechanisms of action. Notably, the extract boasts a substantial history of clinical use, having been utilized to treat thousands of patients with inflammatory diseases over the past 30 years in China, with a reported favorable safety profile.
“We are excited to move Phyto-N forward into formal clinical development,” stated Liqin Xie, Chief Operating Officer of Curanex Pharmaceuticals, in a contact email provided.
Broad Spectrum Potential Beyond Ulcerative Colitis
While ulcerative colitis represents the primary initial indication, Curanex has validated Phyto-N’s efficacy in preclinical animal models across a diverse range of inflammatory conditions. These include atopic dermatitis, COVID-19, diabetes, nonalcoholic fatty liver disease, and gout. This broad spectrum of activity suggests potential for future expansion into multiple therapeutic areas.
Botanical Medicine & the Rise of Phyto-Pharmaceuticals
The development of Phyto-N reflects a growing trend in pharmaceutical research: the exploration of botanical sources for novel drug candidates. Conventional medicine systems worldwide have long utilized plants for their therapeutic properties. Modern science is increasingly focused on isolating and validating the active compounds within these plants, and developing them into standardized, rigorously tested pharmaceuticals.
The advantage of botanical drugs like Phyto-N lies in their potential for complex,multi-target effects,often mimicking the way the body naturally regulates inflammation. This contrasts with many conventional pharmaceuticals which typically target a single pathway. Though, challenges remain in ensuring consistent quality, bioavailability, and demonstrating efficacy through the stringent requirements of regulatory bodies like the FDA.
Looking Ahead: Clinical Trials & Future Development
curanex Pharmaceuticals is currently preparing for the necessary FDA-required studies to support its IND submission. the company anticipates that successful completion of these studies will pave the way for Phase I clinical trials to assess the safety and tolerability of phyto-N in human subjects.
Investor Caution Advised
The company’s declaration includes standard forward-looking statements, cautioning investors that actual results may differ materially from current expectations. Investors are encouraged to review the company’s filings with the Securities and Exchange Commission (SEC) for a comprehensive understanding of the risks and uncertainties involved.
Contact:
Curanex Pharmaceuticals Inc
Attn: Liqin Xie, Chief Operating Officer
info@curanexpharma.com
www.curanexpharma.com
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