- By John Engle
Breakthroughs in medical science happen every year. New compounds that have the potential to cure life-threatening diseases are being investigated and synthesised all the time. But the field of drug delivery is no less important than that of drug synthesis. If a drug does not reach its intended target, or if it is metabolized too quickly by the patient's liver, it will not be an efficient treatment. Significant capital is therefore invested in the development of new types of pill capsule.
Enter Intec Pharma (NTEC) is an Israeli company pioneering a new method of drug delivery. Its "accordion pill" is a folded, accordion-like film inside a gelatin capsule. The capsule dissolves when swallowed, and the multilayer biodegradable film unfolds in the stomach, releasing its contents over the course of the next eight hours. This novel method of drug delivery works particularly well for drugs with narrow absorption windows.
Financials
In its third quarter earnings call a month ago, Intec reported losses of approximately $9.2 million, a year-on-year increase of $1.5 million, or around 19%. As Intec is still a research-stage biotech, this is to be expected. The good news is that the company has around $54.5 million in cash and cash equivalents, which management has indicated will last into 2020. This gives the company a lot of time to hit its milestones, which would allow them to raise additional capital easily, if needed.
Prospects
Intec's main candidate treatment is the Accordion Pill Carbidopa/Levodopa (AP-CD/LD) for the treatment of advanced Parkinson's disease. The company has recently finalized patient enrollment into a Phase 3 trial of AP-CD/LD and expects topline data to be available by mid-2019. Data from a pharmacokinetic (PK) study of AP-CD/LD will be available at the end of 2018, giving investors a catalyst to look forward to. Commercial manufacturing of the drug will take place at the German facility of Lohmann Therapie-Systeme, with whom Intec has a partnership. The manufacturing machine is expected to be ready by year-end. Here's is what Chief Operating Officer Nadav Navon had to say on the use of the accordion pill in the treatment of Parkinson's:
"Levodopa is a classic example for a drug that needs that technology because levodopa suffers from a narrow absorption window ... actually, only in the duodenum."
Furthermore, the company has an early-stage (Phase 1) candidate drug in AP-CBD/THC, the primary cannabinoids found in Cannabis, for various indications including fibromyalgia, lower back pain and neuropathic pain. The accordion pill is designed to increase the absorption times of CBD and THC.
A study carried out by Intec showed that AP-CBD/THC had significant improvements in exposure of CBD (290-330%) and THC (25-50%) compared with Sativex (a commercially available spray containing CBD and THC). The median time of peak concentration was two to three times longer than Sativex and absorption was significantly higher. Importantly, the formation of THC metabolites were meaningfully reduced (more than 25%) and AP-CBD/THC was found to be safe and well tolerated with no serious adverse events reported. While these are obviously early-stage findings, it is encouraging to see a small company diversifying its pipeline.
Finally, it should be noted that the applications of the accordion pill are far wider. If Intec can bring a functioning levodopa/carbidopa accordion pill to market, this will open the doors for many more drugs with narrow absorption windows, increasing commercial interest in the technology many times over.
Verdict
As an developmental-stage biotech, there is obviously a significant level of downside potential to Intec. But the company has a unique drug delivery system with a potentially huge market, promising trial results, enough cash to keep the lights on for the next few years, and the ability to raise more money, if needed. As high-risk, high-reward ventures go, this one has more promise than most.
This article first appeared on GuruFocus.