Keyue Pharma announced the complete data of the phase I clinical trial SYNERGY-1 of KP104

On November 3, Keyue Pharma announced the complete data
of its KP104 clinical phase I trial SYNERGY-1 at the 2022 American Academy of Nephrology (ASN) Annual Meeting held in Orlando, Florida.
Keyue Pharmaceutical is a global biotechnology company
dedicated to the research and development of a new generation of complement drugs for the treatment of immune-mediated diseases.
KP104 is the world's first dual-target complement inhibitor that selectively targets both the complement bypass pathway and the terminal pathway
.

Dr.
Frederick Beddingfield, CEO of Keyue Pharmaceutical, said: "The clinical phase I trial data shows that our product KP104 can inhibit both the bypass pathway upstream and the downstream terminal pathway of the complement system in healthy subjects, thereby effectively inhibiting complement activity
.
Because the complement system is present in both healthy subjects and chronically ill patients, we are confident that KP104 will also exert complement-inhibiting activity
in patients.
We look forward to initiating Phase II clinical trials as soon as possible to evaluate the effects
of KP104 in a number of immune diseases that lack effective treatments.
" "

The evaluation of the key indicators C3b deposition and free C5 levels showed that KP104 had inhibitory effects on both the bypass pathway (AP) and the terminal pathway (TP) of the complement system, and the inhibition was dose-dependent
.
Other observed indicators include rabbit red blood cell (RBC) lysis, which can be used to measure the combined inhibitory effect
of KP104 on AP and TP.
After 1200 mg intravenously administered in a single-dose escalation cohort (SAD), a 99.
9% reduction in free C5 levels and a 98.
6%
reduction in C3b deposition was observed.
At the same dose, 99.
4% of rabbit erythrocyte lysis was observed to be inhibited
.
KP104 is the only biologic
in clinical development that can achieve effective inhibition of both bypass and terminal pathways after a single dose.
Overall, KP104 inhibits rabbit red blood cell lysis, C3b deposition, and free C5 levels by 80-100%
when blood concentrations are greater than 150 μg/mL.

Pharmacokinetic (PK) and pharmacodynamic (PD) results from the multiple dose escalation (MAD) cohort showed that the plasma concentration of KP104 remained stable during dosing and was effective in maintaining the plasma concentration
after the initial single intravenous (IV) loading dose.
The bioavailability of weekly SC administration for 4 weeks is approximately 67%, and this dosing regimen continuously inhibits free C5 levels, C3b deposition, and lysis of rabbit erythrocytes during treatment
.
Data from the Synergy-1 trial also showed that KP104 was safe and well tolerated in healthy volunteers with no deaths, serious treatment-period adverse events (TEAEs), or discontinuation due to drug-related TEAE
.

These Phase I trial data support further clinical trials of KP104 for complement-mediated renal diseases, including IgA nephropathy (IgAN) and C3 glomerular disease (C3G), as well as other immune diseases
.
Keyue plans to initiate three phase II clinical trials of KP104 later this year, which involve multiple indications: kidney diseases including IgAN and C3G, thrombotic microangiopathy secondary to systemic lupus erythematosus (SLE-TMA) and paroxysmal nocturnal hemoglobinuria (PNH).

From today until Wednesday, December 21, 2022, attendees can learn about the presentation
through the online conference platform or offline participation.
From November 5, 2022, the conference poster
can also be viewed on the official website of Keyue.

Details of the presentation are below

: SYNERGY-1: Phase I, first-in-human study evaluating the safety, tolerability, immunogenicity, and single- and multiple-dose escalation of KP104 for PK104

By Paul Wabinitz1, Xiang Gao2, Jay Ma2, Ping Tsui2, Martin Rabe2, Helen Fu2, Chaomei He2, Jingtao Wu2, Brian York2, Qing Yu Christina Weng 2,3, Jon Rankin4, Frederick Beddingfield 2,5, Wenru Song2、Nicholas Farinola1、Richard Lee2

Abstract number: 3761666

Session Name: Glomerular Disease: IgA and Complement-mediated Glomerulonephritis[PO1302-3]

Conference date and time: November 5, 2022, 10:00 a.
m.
to 12:00 p.
m

       ¹ University of South Australia Cancer Institute, 2 Ke Viet Pharmaceutical, 3 Massachusetts General Hospital – Harvard Medical School, 4Syneos Health Sinus, and 5UCLA David Geffen Medical School