Kringle Pharma, Inc. announced that it has completed its pre-IND (Investigation New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan of KP-100IT, a lyophilized formulation of recombinant human HGF, for the potential treatment of acute spinal cord injury. In Japan, KRINGLE completed the Phase 1/2 clinical trial of KP-100IT in patients with the acute phase of spinal cord injury, obtaining positive results confirming safety and suggesting efficacy. In 2019, KP-100IT was designated as an Orphan Drug by the Ministry of Health, Labor and Welfare of Japan.

Since 2020, KRINGLE has been conducting the Phase 3 clinical study. To date, the follow-up of the last patient was completed in this study and KRINGLE plans to announce the top-line results from the study in the first half of 2024. To maximize the value of recombinant human HGF and make the promising treatment broadly available outside Japan, KRINGLE has initiated preparation for the development of KP-100IT in the United States, the largest pharmaceutical market in the world.

The engagement with the FDA for the pre-IND meeting is an important milestone that provides regulatory clarity for KP-100IT on key aspects to advance clinical development in the US. In written responses, the agency provided guidance and addressed KRINGLE's questions related to the FDA's requirements for submitting an acceptable IND, paving the way for the clinical development of KP- 100IT. The FDA's direction will allow KRINGLE to be efficient towards utilizing the preclinical and clinical data accumulated in Japan and formulating an effective development strategy in the US up to the BLA (Biologic License Application).

KRINGLE plans to proceed with the development in the US in partnership with a pharmaceutical company with specialized expertise. KRINGLE is currently in business development discussions with potential partners and the feedback from the FDA will accelerate the negotiations. There are currently no effective options to treat spinal cord injury and the medical need is significant for patients not only in Japan but also in the US and other countries.

KEINGLE is committed to developing an innovative medicine based on HGF originating in Japan and bringing it to patients around the world as quickly as possible.