NIA Small Business Showcase: Neurodon, LLC

Neurodon, LLC, is a biopharmaceutical company aimed at delivering first-in-class, disease-modifying medicines to patients with diabetes, neurodegeneration, and other life-threatening diseases. The company’s novel discovery platform targeting endoplasmic reticulum (ER) stress has enabled the development of small molecules that slow or halt the progression of disease in validated animal models for Alzheimer’s disease, Parkinson’s disease, diabetes, and rare diseases such as Duchenne muscular dystrophy (DMD), amyotrophic lateral sclerosis (ALS), and Darier’s disease. Neurodon’s current pipeline has several investigational compounds that have shown proof of concept in preclinical animal models, which has recently led the company to initiate its investigational new drug (IND)-enabling studies.

The company’s novel patented small molecules correct the aberrant intracellular calcium homeostasis that is at the root of many untreatable diseases. These compounds have the potential to be the first curative treatments for diseases such as diabetes and neurodegeneration; current therapies treat only symptoms. By correcting disrupted calcium homeostasis, Neurodon’s compounds alleviate the cellular stress that is a key driver of pathogenesis. In diabetes, neurodegeneration, and other diseases, excessive ER stress causes cells to lose function and eventually die. The company has demonstrated that its drugs rescue and protect both beta cells and neurons in both cell-based and animal models of disease.

Neurodon is focused on innovative, rigorous scientific investigation followed by rapid clinical translation. A deep understanding of the pathological cellular stress pathways, coupled with the company’s decades of experience in drug development and clinical translation, has enabled the development of candidate medicines that show promise to treat some of the most challenging diseases of our time.

Neurodon is developing the only patented, disease-modifying treatments for diabetes, neurodegeneration, and several orphan indications. The company’s compounds target cellular stress pathways common to a majority of diseases. The company has validated its memorandum of agreement (MOA) in industry-accepted animal models of diabetes, Alzheimer’s disease, and Parkinson’s disease. The combined market for treatments for these diseases is now close to $100 billion. Since there are currently no disease-modifying therapeutics available for these diseases, Neurodon’s novel therapeutics will have the potential to garner a significant share of these markets.

Company Milestones

Scientific

2014: Neurodon founded.
2015-2016: Demonstrated proof of concept in animal models of neurodegeneration, diabetes, and other life-threatening conditions.
2016-2018: Published key publications for diabetes, traumatic brain injury (TBI), Parkinson’s disease, Alzheimer’s disease, stroke, and additional indications. 2019: Selected development candidates for diabetes and select rare indications.
2020: Progressed pipeline for neurodegeneration to late lead optimizations.
2021: Initiated IND-enabling studies for type 1 diabetes (T1D) candidate compound.
2022: Submit IND to U.S. Food and Drug Administration (FDA) for T1D clinical candidate; initiate IND-enabling studies for Alzheimer’s disease and orphan indications.

Business

2015-2021: Filed key patent applications covering lead compounds for multiple indications.
2018: Received Phase 1 Small Business Technology Transfer (STTR) grant from NIA for Alzheimer’s disease.
2019: Granted two patents covering molecules and uses.
2019: Secured angel investment to progress pipeline to development for diabetes and rare diseases.
2020: Received Phase 2 STTR grant from NIA.
2020: Granted five additional patents covering lead molecules and uses.
2020: Secured additional angel investment to fund IND-enabling studies and new indications.
2021-2022: Receives Series A investment to fund clinical trials for T1D and an orphan indication.

Financial Overview

Neurodon, LLC, has raised approximately $4 million of seed funding to date. This funding has enabled the establishment of Neurodon’s offices and labs and the discovery, optimization, and intellectual property (IP) protection of the company’s pipeline candidates. The funding sources include angel investors, STTR Phase 1 and Phase 2 grants from NIA, and funding from state initiatives.

Neurodon plans to raise a Series A investment of $20 million to $30 million to fund clinical trials for T1D and IND-enabling studies for Alzheimer’s disease and other rare disease candidates.

Intellectual Property

Neurodon has seven granted patents and more than 10 pending applications for the company’s first-in-class molecules targeting Neurodon’s pipeline indications. The company also has pending international Patent Cooperation Treaty (PCT) applications covering its development candidates, formulations, and uses.

Product Development and Regulatory Strategy

Neurodon is currently conducting IND-enabling studies for T1D and other rare disease candidates and will submit these IND applications to the FDA in the first half of 2022. It plans to initiate clinical trials on one or more candidates by Q1 of 2023.

Commercialization Strategy

Neurodon is currently seeking a pharmaceutical partner or Series A financing to fund Phase 1-3 clinical trials for T1D and the company’s rare disease indications, as well as support for IND-enabling studies of the company’s Alzheimer’s disease candidates.

Company Details

Neurodon website

Crown Point, IN

Industry: Therapeutics

Management Team:

Chief Executive Officer: Russell Dahl, Ph.D.
Vice President, Operations: Colleen Mauger, RN
Board Director and Advisor: Brunde Broady

Point of Contact:

Colleen Mauger, RN
Email Colleen Mauger
(219) 225-2104

SBIR