Two past Molecules of the Month inductees had significant updates recently, showing they’re still moving forward:
This September ‘22 Molecule of the Month is an IV calcium-sensing receptor (CaSR) agonist first identified in flavor studies of peptides. It is already approved in Japan for secondary hyperparathyroidism (SHPT), and now Pathalys Pharma has raised $150M to advance its development outside of Japan and Asia through additional Ph. III trials.
This oral, once-daily CETP inhibitor and August ‘22 Molecule of the Month recently met its primary endpoint of LDL-C lowering in a Ph. II study (NCT05266586) in combination with ezetimibe as an adjunct to high-intensity statin therapy. The combination had a safety profile comparable to placebo, and NewAmsterdam is advancing the program to Ph. III. CETP inhibitors were intensely studied over a decade ago and this is a continued sign of a second life for this Amgen molecule in high-risk cardiovascular disease patients, a more narrow indication than originally intended.
In our full update of small molecules in the news we also cover recent:
- (B/M)illion-Dollar Molecules: recent M&A’s, IPOs, and other fundraising
- Molecules in Motion: clinical trial updates and FDA filings
- Where Are They Now? updates on past Drug Hunter Molecules of the Month
- Potential Upcoming Approvals: recent NDA filings and upcoming PDUFA dates
Read about all 14 molecules in the full Premium article here.