Raziel Therapeutics, a partner of GC WellBeing, has met the primary efficacy and safety endpoints in a Phase 3 trial in China for its next-generation injectable fat-dissolving drug candidate RZL-012.
According to GC WellBeing on Thursday, the Phase 3 trial was conducted by Zubsta, an affiliate of Fosun Pharma and Raziel's Chinese partner, enrolling 480 adult patients with submental fat, commonly known as a double chin.
RZL-012 met all primary and secondary efficacy endpoints at day 84 after just a single treatment cycle. In the primary efficacy assessment, the drug showed a statistically significant fat-reduction effect, with a response rate more than 30 percentage points higher than the placebo group. Safety results were also favorable.
Fosun Pharma and Raziel plan to file a new drug application with China's National Medical Products Administration based on the results. They also plan to conduct additional clinical trials to expand the drug's indications beyond the double chin to areas including the abdomen and thighs.
RZL-012 is a localized fat-dissolving drug candidate that works by irreversibly destroying targeted fat cells. It is being developed with the goal of reducing fat in specific areas with just one or two injections — fewer than conventional fat-dissolving procedures require.
GC WellBeing sees growing demand for body contouring in specific areas following weight loss, driven by the expanding GLP-1 obesity treatment market. The company's strategy is to position RZL-012 as a body-shaping product that can be used before, after, or alongside GLP-1-based weight-loss treatment.
GC WellBeing holds an exclusive domestic license for RZL-012 and has made a strategic equity investment in Raziel to maintain the partnership. The company expects the Chinese Phase 3 results to have a positive impact on its future commercialization plans in South Korea and its broader push into the obesity and medical aesthetics sectors.
"China is one of the key markets in the global medical aesthetics space, and these Phase 3 results confirm the commercial potential of RZL-012," a GC WellBeing official said. "We will build a differentiated portfolio connecting obesity and medical aesthetics, with RZL-012 at its core."
The RZL-012 development team includes personnel with prior experience in fat-dissolving injectable drugs. Raziel's chief medical officer, Patricia Walker, previously served as head of dermatology therapeutics at Allergan and as CMO of Kythera, where she led the development and global clinical strategy for Kybella, an FDA-approved deoxycholic acid fat-dissolving injectable. Raziel is also preparing to advance RZL-012 into a Phase 3 trial in the United States, following its work in China.
boo@heraldcorp.com
