InMed to Participate in H.C. Wainwright 27th Annual Global Investment Conference, Highlighting Recent Progress in Alzheimer's Treatment Program.

InMed Pharmaceuticals will participate in the H.C. Wainwright 27th Annual Global Investment Conference in New York, where management will conduct one-on-one meetings with investors and present updates on the company's pipeline, including data from its leading pharmaceutical program INM-901 in Alzheimer's treatment. A corporate presentation will also be available online.

Eisai Co., Ltd. and Biogen Inc. have announced the initiation of the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK. This move follows the FDA's grant of Fast Track Status for the drug, which is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) [1].

LEQEMBI IQLIK, if approved, would be the first and only anti-amyloid treatment to offer at-home injection from the start. This would provide a significant advantage for patients and care partners, offering a choice between intravenous (IV) and subcutaneous (SC) administration. The current injection time for each LEQEMBI IQLIK autoinjector takes approximately 15 seconds, making it a convenient option for home use. This development also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring [1].

The sBLA is based on the evaluation of subcutaneous lecanemab administration across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE). The FDA approval of the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections) would allow for a once-weekly starting dose, as an alternative to bi-weekly IV dosing. This would expand the option for patients to receive LEQEMBI treatment from initiation to maintenance at home [1].

LEQEMBI is unique in its ability to target both amyloid plaque and protofibrils, which are believed to contribute to the brain injury that occurs with AD. The drug is currently approved in 48 countries and is under regulatory review in 10 countries. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product [1].

In a separate development, InMed Pharmaceuticals will participate in the H.C. Wainwright 27th Annual Global Investment Conference in New York. Management will conduct one-on-one meetings with investors and present updates on the company's pipeline, including data from its leading pharmaceutical program INM-901 in Alzheimer's treatment. A corporate presentation will also be available online.

References:
[1] https://finance.yahoo.com/news/eisai-initiated-rolling-supplemental-biologics-233000695.html