Pieris – New Cost Effective Treatment for Anemia

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Anemia, Pieris, PIRS
https://commons.wikimedia.org/wiki/File:Iron_deficiency_anemia_blood_film.jpg

Pieris (NYSE: PIRS) is a biopharmaceutical company currently with lots in their pipeline.

Pipeline

Pieris has many drug candidates in their pipeline, which is viewable here.

Only two of them are far enough ahead to discuss, which I’ll get into momentarily.  As the tables above show, Pieris have a lot of partnerships for many of their drugs. 

PRS-080

PRS-080 is an Anticalin against hepcidin that targets the large markets of anemia and functional iron deficiency (FID).

Your body requires iron to survive.  Anemia, by definition, is decreased red blood cells, but there are multiple different types of anemia: iron deficiency, anemia of chronic disease, etc.  Depending on the type of anemia, we have different treatments.  If the patient’s RBC gets too low, we can give an RBC transfusion.  If they have iron deficiency, we can give iron.  For anemia of chronic disease, the best way is to reverse whatever is causing the anemia of chronic disease (cancer, rheumatoid arthritis, kidney failure, etc) but these options are rarely viable, thus, we give iron and erythropoeitin, which is costly.

Hepcidin

Hepcidin is a regulator of iron absorption in the gut.  Your body typically will absorb iron from the foods that you consume, and hepcidin will either increase iron absorption or decrease iron absorption based on what your body needs.  Hepcidin works by blocking the iron absorption, so if your body has too much iron, hepcidin will work overtime to ensure that your body doesn’t absorb more iron than you need.  So if the patient has low iron, and then blocking hepcidin (thus, blocking the blocker) would raise iron levels.

PRS-080 

Enter PRS-080.

During phase I, was well tolerated, with no serious adverse events (SAEs) observed in the single ascending dose (SAD) study at six dose levels administered by intravenous infusion in 48 healthy male subjects ranging from 0.08 to 16.0 mg/kg. Reported AEs were of mild to moderate severity with no apparent dose dependency or difference between active and placebo treatment groups. The plasma half-life of PRS-080 ranged between 71 and 81 hours among dose cohorts.

PIRS, Pieris, Hepcidin, PRS-080
http://c.eqcdn.com/_8ffb87b647b4972ad5a4f74b0376bbaa/pierisag/db/164/2138/pdf/Poster_ERA-EDTA_final_25052017_ohne+Anleitung.pdf

As the study above shows, within one hour of administration, there was a marked increase in serum iron concentration and transferrin saturation. Moreover, the duration of serum iron elevation and transferrin saturation also increased in a dose-dependent manner. Among all subjects receiving doses of 1.2 mg/ml+, statistically significant increases in total serum iron mobilization were observed relative to placebo (p=.005).

Feel free to check out the poster here.

There is some significant competition out there for a hepcidin antagonist:

  • Celgene/Acceleron – Luspatercept – Phase III – for anemia with beta thalassemia
  • Noxxon – NOX-H94 – Phase II
  • Abbvie – ABT-207 – Pre-clinical – for anemia with inflammation

PRS-060

PRS-060 is an immunotherapy treatment for uncontrolled asthma.  Immunotherapy is still relatively new in the world of asthma, as most patients stick with steroids or beta agonists.  PRS-060 is an inhaler that delivers IL4Ra-targeting anticalin to the lungs, where it works against certain cytokines and interleukins.  It’s still under development and is still in the IND phase.

 

Financials

As of ER 2q2017, the company had $100m in cash/equivalents with a $10m per quarter burn.  Shouldn’t need funding for a while.

 

Overall

Without completing phase II, it’s still a bit early to tell on how this will play, but so far, it looks promising.  That with the company not needing any financing any time soon, I’m optimistic.  What worries me slightly is just how spread out the company is in terms of their pipeline.

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Disclosure:  I have a long position in this company.

Feel free to read my other articles.