Zhitong Finance App News, Tianchen Bio-B (01779) announced that the top-line data of the phase II clinical trial (phase II clinical trial) of LP-005 (a bifunctional antibody fusion protein independently developed by the Group targeting C5 and C3b supplements and used to treat paroxysmal nocturnal hemoglobinuria (PNH)) has been read in China. These top-line data show that LP-005 has significant efficacy and good safety and tolerability characteristics.
LP-005 is the first product of the Group's bifunctional antibody development platform, and is a bifunctional antibody fusion protein targeting C5 and C3b complements. As a multi-target complement inhibitor, LP-005 simultaneously acts on multiple key nodes of the complement cascade reaction and completely inhibits all three complement signaling pathways (i.e. classical pathway, bypass pathway, and lectin pathway). Compared to single-target inhibitors, it is expected to block complex disease pathogenesis more comprehensively. Potential indications for LP-005 include complement-mediated autoimmune diseases such as PNH, complement-mediated kidney disease, and periodontitis.
PNH is a rare acquired cloned hematopoietic stem cell disease characterized by chronic intravascular hemolysis, thrombosis, and bone marrow failure. Patients usually show symptoms such as fatigue, hemoglobinuria, abdominal pain, difficulty breathing, and anemia, and major vascular adverse events may occur. Existing complement inhibitor therapies have improved clinical outcomes for patients to some extent.
LP-005 is a novel bifunctional fusion protein that can simultaneously inhibit both proximal and terminal complement pathways, and has a long half-life.
The phase II clinical trial is a multi-center, randomized, open-label phase II clinical study (registration number: CTR20242478) conducted in China to evaluate the efficacy, safety, and pharmacokinetic characteristics of LP-005 injections in patients with PNH. The trial included three dose cohorts of 900 mg, 1,200 mg, and 1,500 mg. The subjects received intravenous (Q4W) infusions every 4 weeks, for a total treatment period of 48 weeks.
The main endpoints of the phase II clinical trial include: (i) changes in serum lactate dehydrogenase (LDH) levels in the 12th week after administration; and (ii) the proportion of patients who did not need blood transfusions and whose hemoglobin (Hb) levels increased by ≥2 g/dL from baseline in the 24th week after administration.
A total of 30 patients with PNH were enrolled in the phase II clinical trial. Of these, 27 patients completed 24 weeks of treatment.
At week 12, LDH levels dropped significantly from baseline. The hemolysis control rate (LDH below 1.5 × upper limit of normal value (ULN)) in the 1,200 mg and 1,500 mg dose groups reached 100%. A 100% transfusion avoidance rate was achieved in all three dosage groups, and no breakthrough hemolysis (BTH) was observed.
At week 24, 85.7% (6/7) of patients in the 1,500 mg group achieved a hemoglobin increase of ≥2 g/dL without a blood transfusion, and 71.4% (5/7) of patients had hemoglobin greater than 120 g/L. Avoid a transfusion rate of 100% (7/7), and no BTH was observed.
Lp-005 showed strong hemolysis control and Hb improvement effects.
In terms of safety, no treatment-related serious adverse events (SAEs) have been reported. Overall, LP-005 shows good safety and tolerability characteristics.
The board believes that the top-line data from the phase II clinical trial confirms that LP-005 has a competitive advantage in efficacy as a dual-target complement inhibitor, and also has good safety and tolerability characteristics, while the Q4W dosing interval reflects the long-term advantages of LP-005. These results support further advancing clinical development of LP-005.