Canurta Submits Pre-IND & Orphan Drug Applications, Advances AI Drug Development & Launches WSU Research

Regulatory Progress: Pre-Investigational New Drug (Pre-IND) Type C document submitted to the U.S. Food and Drug Administration (FDA)

On February 6, 2025, Canurta Therapeutics successfully submitted its Pre-Investigational New Drug (Pre-IND) Type C document to the U.S. Food and Drug Administration (FDA), marking a critical regulatory milestone for CNR-401, our lead botanical therapeutic for Amyotrophic Lateral Sclerosis (ALS).

Engaging with the FDA at this stage is essential for streamlining our clinical trial strategy, refining study requirements, and aligning our development pathway with regulatory expectations. This Type C meeting request will provide invaluable insights into CNR-401’s clinical and regulatory trajectory. We anticipate receiving the FDA’s feedback by early April 2025, which will guide our next steps.

At Canurta, we remain committed to pioneering scientifically validated botanical therapeutics while adhering to rigorous regulatory requirements. As we progress through this pivotal phase, we will continue to provide updates on our progress toward clinical trials.

Canurta Submits Orphan Drug Designation (ODD) Application for CNR-401

In more exciting news, on February 17, 2025, Canurta officially submitted its Orphan Drug Designation (ODD) application to the U.S. Food and Drug Administration (FDA) for CNR-401, our lead candidate for Amyotrophic Lateral Sclerosis (ALS). This milestone represents a significant step in our regulatory strategy as we advance CNR-401 toward clinical trials.

Orphan Drug Designation is granted to therapies aimed at treating rare diseases affecting fewer than 200,000 patients in the U.S. If approved, this designation will provide regulatory benefits, including tax credits for clinical trials, market exclusivity upon approval, and access to expedited regulatory pathways. Securing ODD status will help accelerate CNR-401’s development and bring much-needed therapeutic options to ALS patients.

Canurta Enhances its Analytical Precision and AI-Driven Quality Control

This month, Canurta’s bioinformatics team further refined its analytical and quality control capabilities by integrating advanced chromatographic data into our molecular fingerprinting model. This enables precise characterization of active constituents and minor components, ensuring batch-to-batch consistency and strict adherence to Chemistry, Manufacturing, and Controls (CMC) standards.

Our AI-driven data analytics platform continues to strengthen large-scale research by optimizing comparisons between clinical study data and public datasets, accelerating discovery and validation in botanical drug development. We have also streamlined bioinformatics workflows in the cloud, automating pipeline execution for scalable genomic data processing—reducing manual configuration, accelerating analysis timelines, and optimizing resource efficiency. Additionally, our AI agent now queries proprietary compound libraries and initiates virtual screening, with ongoing advancements toward full automation of hit prioritization.

Canurta remains at the leading edge of AI-powered botanical drug innovation, driving precision, efficiency, and scalability across every stage of research and formulation.

Advancing Preclinical Research with Washington State University

Canurta Therapeutics has launched a research collaboration with Washington State University to evaluate CNR-401’s therapeutic potential in a Drosophila melanogaster (fruit fly) model. This preclinical study will provide critical insights into CNR-401’s impact on key ALS-related pathways, including neuroinflammation, oxidative stress, and protein aggregation.

The fruit fly model is widely recognized for its efficiency in dissecting neurodegenerative disease mechanisms. This research complements our work in C. elegans and zebrafish models, strengthening the scientific foundation for CNR-401’s therapeutic application.

Update: Canurta’s Participation in the 11th Annual Canada-Chicago Mentoring Program (C2MP) Kickoff Well Received

Canurta is pleased to share that the audience enthusiastically engaged with our participation in the 11th annual Canada-Chicago Mentoring Program (C2MP) kickoff. As one of only five Canadian companies selected for this prestigious program, we showcased our innovations to a distinguished group of industry leaders, investors, and U.S. market experts.

During the virtual event on February 12, 2025, Canurta’s presentation sparked insightful questions from the audience about Canurta’s market strategy, regulatory approach, and the potential impact of its lead candidate, CNR-401, on neurodegenerative disease treatment. Following this successful kickoff, Canurta looks forward to working closely with its mentors.