IntelGenx reports clinical progress on delivery of Alzheimer’s drug
The study offers great hope to Alzheimer patients as it shows improved drug delivery especially since the study data confirmed that Montelukast crosses the blood/brain barrier when administered using IntelGenx’s VersaFilm™ delivery technology.
This is exciting as montelukast sodium offers important drug repurposing opportunity that IntelGenx has in its product pipeline, which could potentially become a multi-billion-dollar product in the large and underserved market for degenerative diseases of the brain.
First developed by Merck in Montreal, montelukast sodium (trade name Singulair) is registered for the treatment of asthma and seasonal allergies. But recently a team of scientists at Institute of Molecular Regenerative Medicine at the Paracelsus Medical University in Salzburg, Austria demonstrated that montelukast sodium structurally and functionally rejuvenates the aged brain.
As such, when delivered through the VersaFilm™ system, montelukast sodium offers a unique drug repurposing opportunity for the treatment of degenerative diseases of the brain, such as mild cognitive impairment and Alzheimer’s disease, the most prominent form of dementia.
In addition, the study also confirmed the usefulness of IntelGenx’s VersaFilm™ as a better substitute for classical drug delivery system. VersaFilm™ is patent protected and is supported by a $6 million state-of-the-art manufacturing line, which is expected to become the company’s core business.
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The study was designed as a single-dose, randomized, two-way crossover pilot study in 8 healthy subjects. AUC0-inf was 3863 ± 1343 ng/ml*h-1 for the IntelGenx product vs. 2697 ± 1003 ng/ml*h-1 for the reference product Singulair® tablets, representing a 52% increase in bioavailability of the drug after administration of the IntelGenx film product.
IntelGenx has begun preparation for a phase II-a proof-of-concept (POC) study. Patient enrolment for this study is expected to commence in Q1/2017. The Company expects the results from the study to be available in Q4/2017. Based on the outcome of this first efficacy trial in humans, IntelGenx will be actively seeking a partnership or alliance opportunity to further advance developmental work and commercialization of this product.
On August 11, 2016 IntelGenx’s reported its second quarter 2016 financial results for the three-month and six-month periods ended June 30, 2016. The highlights for the 2016 Second Quarter Financial were:
- Revenues reached $672 thousand, an increase of 15% over the same period last year
- Net comprehensive loss was ($806 thousand), compared to a net comprehensive loss of ($220 thousand) over the same period last year
- Adjusted EBITDA loss was ($665 thousand), compared to adjusted EBITDA loss of ($186 thousand) over the same period last year
- Cash and cash equivalents totaled $1.1 million as at June 30, 2016. Subsequent to quarter end, the Company monetized its royalty on future sales of Forfivo XL® to SWK Holdings Corporation for $6 million (CAD$8 million).
- Signed the first definitive agreement for Rizaport™ with Grupo Juste for Spain and additional potential territories
- Continued late-stage discussions with global pharmaceutical companies for multiple products with the potential goal of concluding a definitive agreement to be finalized in the third quarter of 2016
- Initiated a phase 1 study of Montelukast for the treatment of degenerative diseases of the brain, such as: mild cognitive impairment and Alzheimer’s disease, the most prominent form of dementia. IntelGenx expects results from the phase 1 trial to be available in September 2016.
Dr. Luc C. Duchesne is a Speaker and Author with a PhD in Biochemistry. With three decades of scientific and business experience, he has published ... <Read more about Dr. Luc Duchesne>