A little read of the Amylyx Pharmaceuticals Fourth Quarter report released last week makes interesting reading.
These Phase 1 results, with indicative efficacy results only, simply MUST be discussed at their next Board Meeting, as pretty much their entire revenue is at risk IMHO.
Recent Business Highlights: Commercial launches of RELYVRIO® in the U.S. and ALBRIOZA™ in Canada, also known as AMX0035, continued to progress, and eligible people living with ALS in multiple countries are also accessing RELYVRIO through early access pathways. Net product revenue for the three months ended December 31, 2023 was $108.4 million, compared to net product revenue of $102.7 million for the three months ended September 30, 2023. The vast majority of Amylyx’ net product revenue is generated in the U.S.; revenue in Canada and from named patient sales programs in international markets represented an important source of revenue growth in three months ended December 31, 2023 relative to the Company’s financial results for the three months ended September 30, 2023.
But warning .... look at these warnings & disclaimers at the end of the Amylyx Pharmaceuticals Fourth Quarter report.
Risk in Patients with Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders
RELYVRIO contains taurursodiol, which is a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for worsening diarrhea, and patients should be monitored appropriately for this adverse reaction. Pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids may also lead to decreased absorption of either of the components of RELYVRIO. Because different enterohepatic circulation, pancreatic, and intestinal disorders have varying degrees of severity, consider consulting with a specialist. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis) were excluded from the study; therefore, there is no clinical experience in these conditions.
Use in Patients Sensitive to High Sodium Intake
RELYVRIO has a high salt content. Each initial daily dosage of 1 packet contains 464 mg of sodium; each maintenance dosage of 2 packets daily contains 928 mg of sodium. In patients sensitive to salt intake (e.g., those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of RELYVRIO and monitor appropriately.
ADVERSE REACTIONS
The most common adverse reactions (at least 15% and at least 5% greater than placebo) with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Gastrointestinal-related adverse reactions occurred throughout the study but were more frequent during the first 3 weeks of treatment.
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With regards to safety, Monepantel just hit the ball out of the park vs Relyvrio .
With regards efficacy ... I know, I know, just 12 patients .... even the worst result, which was for cohort 1 on 2mg = Relyvrio efficacy.
Can anyone imagine a situation where we don't at least equal, or better, the worst results in this Phase 1/2 study in the Phase 2/3 study ... given safety is such I struggle to see a situation in which the trial would be stopped prematurely.
Best call that board meeting Amylyx Pharmaceuticals ... you've got some business tactics to dicsuss.
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