Uni-Bio Science Completes Phase I Single Ascending Dose (SAD) Tolerability Study of Uni-EPO-Fc for Treatment of Anaemia

Mar 08, 2016 20:24 JST

Source: Uni-Bio Science Group Limited

- High safety and tolerance indicated
- Lower and less frequent doses can notably increase reticulocyte count
in healthy subjects
- Long-acting formulation has potential to offer patients greater treatment convenience and lower the cost of care

HONG KONG, Mar 08, 2016 - (ACN Newswire) - Uni-Bio Science Group Limited ("Uni-Bio Science" or the "Group;" HKEx code: 690) today announced that its long-acting Human Erythropoietin-Fc fusion protein injection ("Uni-EPO-Fc") has successfully completed the single ascending dose tolerability study of the Phase I clinical trial.

The study tested the safety and tolerability of Uni-EPO-Fc in 40 healthy subjects within seven dosage groups. Results show that Uni-EPO-Fc was extremely well tolerated with no significant adverse events. Only 3 subjects among the 40 participants who completed the clinical studies experienced low fever or slight injection site irritation which disappeared within 24 hours. Moreover, Uni-EPO-Fc facilitated an increase both in absolute value and percentage of blood reticulocytes in healthy subjects.

Uni-EPO-Fc is indicated for treating anaemia caused by renal diseases, chemotherapy and HIV treatment.

Mr. Kingsley Leung, Executive Director of Uni-Bio, said: "We are very encouraged by the results of the phase I single-ascending dose tolerability study and we are excited by the potential of Uni-EPO-Fc in China. The EPO market in China is expected to become the largest in the world due to a high prevalence of chronic kidney disease cases. However, it is still an under-penetrated market due to patients' resistance to frequent injections; an EPO with weekly or monthly dosing thus has important advantages.

"We have been seeing several large inbound deals for long-acting EPOs recently, and it is definitely a very exciting area to be in. Uni-Bio Science's long-acting EPO is leading the charge, and it may become the first-to-market. The positive results of our phase I SAD tolerability study are a strong start to our clinical development program."

The Group has moved Uni-EPO-Fc into multiple ascending dose tolerability stage of phase I clinical study, and expects all phase I clinical studies to be completed by the end of 2016.

About Uni-EPO-Fc

EPO is a glycoprotein hormone that can increase the proliferation and differentiation of BFU/CFU-E and maturation of red blood cells. It is vital to the production of red blood cells, and ultimately, oxygen in the human body. Currently, EPO treatment is widely used in treating anaemia caused by renal insufficiency, chemotherapy and HIV treatment, as well as preoperative autologous donation to avoid infection by blood-borne diseases. According to Frost and Sullivan (2015), the rhEPO market in China is expected to reach US$477 million by 2018 (growing at 18.5% per year) and the global anaemia therapeutics market is worth more than US$12 billion. Despite the large market, current EPO usually last for only six to eight hours within the human body's half-life blood serum loop which often results in long-term treatment and frequent dosing. This significantly increases patients' treatment costs and seriously lowers the patents' quality of life due to their high dependence on medicines. Thus, a long-acting EPO treatment is urgently needed in a clinical setting.

Uni-Bio Science Group has developed an EPO-Fc fusion protein injection (Uni-EPO-Fc) using recombinant DNA techniques, which potentially has once-fortnightly treatment frequency. The fusion protein technique developed by the Group has the potential to overcome the shortcomings of the traditional fusion technique using IgG1-Fc. The project have been supported by the PRC Ministry of Science and Technology following its selection as a 'New Key Drug Formulation' in the State's Major Science and Technology Project under the 'Eleventh Five-Year Plan.

Contact:

Strategic Financial Relations Limited
Veron Ng     Phone: +852 2864 4831  Email: veron.ng@sprg.com.hk
Angelus Lau  Phone: +852 2864 4805  Email: angelus.lau@sprg.com.hk
Caley Chan   Phone: +852 2114 4950  Email: caley.chan@sprg.com.hk
Fax: +852 2527 1196

Source: Uni-Bio Science Group Limited
Sectors: Daily News, BioTech