Sarawak General Hospital first Asia-Pacific site for global first-in-human SLE clinical trial

The first-in-human (FIH) trial on a new experimental drug to treat patients with systemic lupus erythematosus (SLE) will be conducted at Sarawak General Hospital (SGH), making it the first research center in the Asia-Pacific region to do so.

The trial led by consultant rheumatologist, Dr Teh Cheng Lay, will be conducted in SGH’s Clinical Research Centre, which is an accredited FIH facility under the National Pharmaceutical Regulatory Agency. “SLE predominantly affects women aged 15 to 50 years old as the group makes up to 80 percent of the over 10,000 people diagnosed with SLE in Malaysia. There is a need to explore new treatment options that provide minimal side effects, as many SLE patients develop other underlying health complications due to this chronic illness,” said Teh. SLE is an autoimmune condition that affects joints, skin, brain, lungs, kidneys, and blood vessels.

Teh was enthusiastic when Roche Pharmaceuticals confirmed SGH was selected as one of only seven global institutions, with other global sites located in Europe and South Africa, to conduct the FIH trial. She trusts that the experience and resources available at SGH will enable the center to contribute to pertinent safety data of the experimental drug amongst the Asian population.

The announcement was made during the Clinical Research Excellence in Early Phase and People Development event by Clinical Research Malaysia (CRM) that was officiated by the Minister of Health, Datuk Seri Dr Dzulkefly Ahmad. “Malaysia’s clinical trial ecosystem has developed rapidly with over 2,300 clinical research conducted since 2012. CRM through its Phase 1 Realisation Project initiative have overseen the development of the country’s early phase ecosystem, to enable safe and regulated conduct of early phase research especially FIH trials,” said Dzulkefly.

Following the completion of P1RP in 2021, Malaysia has conducted one FIH and two First-in-Patient studies, with Roche’s study being the first FIH in Malaysia under a rheumatology indication, added Dzulkefly. Roche is the first multinational company to bring its FIH trials under a rheumatology indication to Malaysia, which exemplifies Malaysia’s growing clinical trial capabilities in Asia and only within 2 years from the completion of CRM’s Phase 1 Realisation Project (P1RP) which enabled the FIH ecosystem in the country.

Representing Roche, Deepti Saraf, the General Manager of Roche (Malaysia) Sdn. Bhd., said: “One aspect of concern for women with SLE is its potential impact on fertility and pregnancy. At Roche, women’s health is a priority for us, as we aim to develop tailored solutions to improve women's quality of life, and also empower women to take charge of their well-being through education, early detection, and personalized care.”