Matinas: Learning From Amarin's Mistakes

Summary

  • Matinas has an OM3 drug that has demonstrated a superior profile to Amarin's Vascepa.
  • It has a platform and, unlike Amarin, a diverse pipeline.
  • I hope the company will learn from Amarin's mistakes and ensure proper protection for its IP moat.
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Matinas Bio (MTNB) has been discussed as a competitor for Amarin (AMRN), which was a big deal early last year when Amarin was going toward attaining blockbuster status. Then the world collapsed around Amarin, and today, being Amarin’s competitor does not mean you can eat away at Amarin’s profits, rather it means that generic Vascepa can eat away at yours.

Therefore, it's better for a company like Matinas - which actually came on my radar as an Amarin competitor during those heady days I was covering Amarin - to diversify from the TGL-lowering-drugs area as much as possible. Amarin always had that problem. It always was a one-trick pony. Matinas, I am glad to notice, isn't like that. It's a regular biopharma with a platform that produces multiple drugs, one of which just happened to be a Vascepa-competitor. But there are other drugs there.

This platform is called LNC, or lipid nano-crystal delivery platform. According to Matinas, LNC enables safe, oral, intracellular delivery of medicines. This platform produces its three assets. Lead product candidate MAT9001 is a prescription-only omega-3 free fatty acid formulation for the treatment of cardiovascular and metabolic conditions currently about to begin registrational studies in severe hypertriglyceridemia (TGs > 500 mg/dL). The company also offers MAT2203, an oral formulation of amphotericin B that has completed Phase II clinical trials for the prevention of invasive fungal infections due to immunosuppressive therapy in patients. In addition, it offers MAT2501, an orally administered formulation of the broad-spectrum aminoglycoside antibiotic amikacin that has completed Phase I clinical trials.

Trial data

MAT9001 comprises a unique mix of potent omega-3 free fatty acids, most notably eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA). Vascepa, on the other hand, is highly purified EPA but may contain very small traces of DHA. Currently, MAT9001is in an ongoing phase 2 study, but the most important study it has completed is a head to head study against Vascepa in a small number of patients. This was an open label, randomized, active controlled study in 42 patients. Vascepa is prescribed along with statin therapy, however MAT9001 claims it doesn’t need statin therapy backbone for dosing. So the trial design took in both types of patients, treatment naive and treated patients. Patients with triglyceride levels between 200-400 mg/dL (without lipid-altering Rx) and between 200-350 mg/dL (with stable–dose statin monoRx) were included. About this design, Amarin has complained that it did not meet Vascepa’s FDA-prescribed dosing criteria. That could be true, however the fact is that what's important in a head to head trial is to make the playing fields level, and Matinas seems to have done that.

Patients were given 4mg of one drug for 14 days, data was collected, then after a five-week washout period when they all returned to baseline, the other drug, in a randomized fashion, was given, and data collected after 14 days.

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