FORIGERIMOD

CHEMICAL NAMES
1. L-Tyrosine, L-arginyl-L-isoleucyl-L-histidyl-L-methionyl-L-valyl-L-tyrosyl-L-seryl-L-lysyl-L-arginyl-O-phosphono-L-serylglycyl-L-lysyl-L-prolyl-L-arginylglycyl-L-tyrosyl-L-alanyl-L-phenylalanyl-L-isoleucyl-L-α-glutamyl-
2. O3,140-phosphono(human U1 small nuclear ribonucleoprotein 70 kDa (snRNP70))-(131-151)-peptide

MOLECULAR FORMULA C117H181N34O32PS
MOLECULAR WEIGHT 2639
TRADEMARK Lupuzor
SPONSOR Cephalon, Inc.
CODE DESIGNATION IPP 201101
CAS REGISTRY NUMBER 497156-60-2

STRUCTURAL FORMULA

stucture, http://www.ama-assn.org/ama1/pub/upload/mm/365/forigerimod.pdf

1. Forigerimod nonproprietary drug name

   http://www.ama-assn.org/resources/doc/usan/forigerimod.pdf‎

   STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL. USAN. FORIGERIMOD.

   …………………………………………………………………………………………………………..

   FORIGERIMOD ACETATE

   CAS REGISTRY NUMBER 1160237-55-7  of acetate

   http://www.ama-assn.org/resources/doc/usan/forigerimod-acetate.pdf

    

2. Forigerimod acetate nonproprietary drug name

   http://www.ama-assn.org/resources/doc/usan/forigerimod-acetate.pdf‎

   STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL. USAN. FORIGERIMOD ACETATE

   str is

   FORIGERIMOD ACETATE

Forigerimod, also known as Lupuzor or CEP-33457, (SyB L-1001) is a CD4 T-cell modulator being investigated for the treatment of systemic lupus erythematosus (SLE). In the Phase II trials, Lupuzor was administered subcutaneously at a dose of 200 mcg once a month for 3 months. The Phase III study is anticipated to be complete in September 2012 and will measure the proportion of patients achieving a combined clinical response using the SLE responder index.

Positive final Lupuzor trial results. Marketwire. www.marketwire.com/press-release/Positive-Final-Lupuzor-Trial-Results-AIM-IMM-1176375.htm. Published November 19, 2009. Accessed June 18, 2011.

Rigerimod (IPP-201101, Lupuzor) is a polypeptide corresponding to the sequence 131-151 of the 70k snRNP protein with a serine phosphorylated in position 140.^[1]

It gave encouraging results in a phase IIb trial for severe lupus.^[1] Another phase IIb trial has started recruiting in the US.^[2]

References

The latest highlights of Lupuzor’s™ development as a treatment for lupus include:

• An ‘End of Phase 2’ meeting package with ImmuPharma’s Phase IIb data was submitted to the FDA and the FDA responded to all the questions
• The Investigational Medicinal Product Dossier (IMPD) submitted via the Voluntary Harmonized Procedure (VHP) in the EU was approved
• The Scientific Advice meeting with the European Medicines Evaluation Agency (EMEA) was held; the recommendations were very similar to those in the FDA’s ‘End Of Phase 2’ responses. Recommendations were incorporated into the Phase III pivotal programme
• The Japanese equivalent authorities (PMDA) have agreed to the initiation of clinical trials in Japan
• The FDA has granted Lupuzor™ the approval to start Phase III with a Special Protocol Assessment (SPA)
• The FDA has granted Lupuzor™ Fast Track designation

How Lupuzor™ works in the treatment of lupus

Lupuzor™ is a drug that specifically modulates the immune system of lupus patients by modifying the behaviour of some of the key cells involved in the pathogenesis of the disease. The clinical profile of lupus patients is generally assessed by standardised scales such as SLEDAI (SLE Disease Activity Index): the lower the score, the better the condition of the patient. During this Phase II study, the SLEDAI scores were assessed on multiple occasions even though the study was not designed or powered to demonstrate clinical benefit as the primary endpoint due to the short treatment period.