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news.Gliknik has announced that its licensee Pfizer has received orphan drug designation from the US Food and Drug Administration (FDA) for its autoimmune candidate drug GL-2045 for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disorder.
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CIDP is characterized by progressive weakness and impaired sensory function in the legs and arms.
GL-2045, a recombinant Intravenous Immune Globulin (IVIG)-mimetic, received the orphan drug status for CIDP under the US Orphan Drug Act following a review by the FDA of a package of data submitted by Pfizer.
Gliknik and Pfizer entered into an exclusive licensing agreement for GL-2045 in September 2013.
Gliknik CEO David Block said: "This orphan drug designation is important in that it provides numerous incentives to develop GL-2045 to address an unmet need in CIDP, a rare neurological disorder."
The company noted that GL-2045 may eventually provide patients an alternative that is at least as effective as IVIG but potentially more convenient and safer without the risk of blood-borne pathogens.
Gliknik, which has expertise in modulation of the immune system to fight disease, is developing new therapies for patients with immune disorders and cancer.