Business
Enlivex Announces Reprioritization Plan and Second Quarter 2023 Financial Results
The Company intends to increase its existing focus on inflammatory and autoimmune indications. The Company, since its inception, considered the inherent
About this update from Enlivex Ltd.
[{"type":"text","content":"The Company intends to increase its existing focus on inflammatory and autoimmune indications. The Company, since its inception, considered the inherent properties of AllocetraTM as an innovative, highly-differentiated modality for immune resolution across a wide variety of inflammatory and auto-immune indications with unmet medical needs that received strong interest from large pharma, physicians and patients. As part of the strategic reprioritization plan, in addition to the ongoing Phase II trial of AllocetraTM in patients with sepsis, the Company has initiated a clinical program in osteoarthritis, a degenerative disease with low grade inflammation, and an indication with a substantial unmet medical need that potentially represents a multibillion commercial market. The revised strategy is targeted at obtaining topline data readouts from two advanced-stage clinical indications by mid-2025 – (a) a randomized, controlled Phase II trial in 120 patients with sepsis with a targeted topline data readout by the end of Q1 2024, and (b) a randomized, controlled Phase II trial in 120-150 patients with moderate knee osteoarthritis, with a targeted topline data readout by the end of Q2 2025. In the two ongoing oncology clinical trials, 15 patients with advanced malignancies of different origins who were heavily pre-treated with multiple lines of therapy prior to the study, were treated with repeat doses of AllocetraTM given intravenously or intraperitoneally. Most patients received monotherapy treatment and lower doses of AllocetraTM. Results demonstrated acceptable tolerability and safety, allowing the program to proceed to assess the efficacy of AllocetraTM in solid tumor indications in combination with other therapies and at higher doses. Pursuant to the strategic reprioritization plan, and in light of the new guidelines and regulatory initiatives set by the FDA for drug development in oncology that may result in longer clinical development timelines required for regulatory approvals, the Company will cease the internal clinical development of our various oncology indications and plans to seek external collaborations or out-licensing opportunities for its oncology assets. The Company recently dosed the first patient in a Phase I/II investigator-initiated clinical trial of patients with end-stage knee osteoarthritis who had been schedul...