top of page

Opportunity to License SP16, A Novel Treatment For Acute Kidney Injury (AKI)


Serpin Pharma (“Serpin”) is an anti-inflammatory/immunology company focused on developing its patented (CoM and use) SP-16 LRP1 agonist platform to treat diseases in which cellular dynamics that normally control inflammation are imbalanced. Based on its discovery of SP-16, a highly potent portion of alpha-1 anti-trypsin (A1AT), a complex molecule to treat alpha1-proteinase inhibitor (A1-PI) deficiency, Serpin is pursuing several indications for SP-16.


Serpin’s lead indication is the treatment of inflammation related to acute kidney injury (AKI), often a result of cardiac surgery. This indication, designated SRP 100, is being studied in a Phase 2a academic collaboration study at Frederick Alexander University (FAU) following a successful RCT Phase 1 trial in 24 healthy individuals showing SP-16’s safety at doses up to 12 mg/kg SP-16


Serpin had a pre-IND meeting with the FDA regarding the AKI indication resulting in the FDA not requiring any additional conditions for submitting an IND.


Encouraged by these results and a $2.2 billion acquisition of InhibRx by Sanofi in January of 2024 for a Phase 2 recombinant A1AT, Serpin now seeks a partner to help complete the development and commercialization of SP-16 for the treatment of AKI.


Serpin has also completed a successful 10-subject Phase 2a trial in acute myocardial infarction (AMI) patients administered SP-16 twelve (12) hours after a confirmed AMI. This trial showed a significant decrease in AMI biomarkers, e.g., CKMB, troponin and others and resulted in improved long-term heart function (results are published in July 2022). Serpin has been awarded a grant to conduct an RCT, 60 patient phase IIa study at Sheba Hospital in Israel. Serpin’s clinical collaborators for both the AKI and AMI indications will handle regulatory filings with EMEA.


Serpin has also licensed one of its peptides to Estée Lauder for cosmeceutical purposes and has entered a license to the rights of SP-16 with HekaBio for a single indication (Chemotherapy-Induced. Peripheral neuropathy) for the Asian region.


Serpin is working with the Sage Group to identify one or more global or regional partners for SP16.

Comments


Featured Posts
Recent Posts
Archive
Search By Tags
Follow Us
  • Facebook Basic Square
  • Twitter Basic Square
  • Google+ Social Icon
bottom of page