Amgen and Kyowa Kirin reveal promising phase 3 results for rocatinlimab in atopic dermatitis

Amgen and Kyowa Kirin have presented encouraging outcomes from a phase 3 trial concerning their novel T-cell rebalancing therapy, rocatinlimab, aimed at treating atopic dermatitis (AD). The IGNITE study, spanning 24 weeks, successfully met its co-primary endpoints, alongside all significant secondary endpoints. This trial focused on assessing two varying doses of the experimental treatment in over 760 adults suffering from moderate-to-severe AD, including individuals who had previously been treated with biologic or systemic Janus kinase inhibitor medications.

The study revealed that 42.3% of participants receiving the higher dose of rocatinlimab achieved at least a 75% decrease from baseline in their Eczema Area and Severity Index score (EASI-75), which marks a notable 29.5% improvement over placebo. Those treated with the lower dose showed that 36.3% reached EASI-75, exhibiting a 23.4% enhancement compared to placebo.

Moreover, the research indicated that 23.6% of patients administered the higher dose and 19.1% of those given the lower dose attained a validated Investigator’s Global Assessment for Atopic Dermatitis score of zero or one, representing clear or almost clear skin. This was accompanied by a minimum two-point reduction from baseline at week 24, reflecting a 14.9% and 10.3% improvement against placebo, respectively.

Atopic dermatitis is recognized as the most prevalent form of eczema, impacting up to 20% of children and 10% of adults globally. This inflammatory skin condition leads to extremely dry, itchy skin, which can be painful. Individuals with moderate-to-severe cases endure chronic symptoms and unpredictable flare-ups, causing considerable discomfort and disruption to daily life.

Rocatinlimab operates by targeting the OX40 receptor, which plays a crucial role in triggering both systemic and localized inflammatory responses in AD and other health conditions, such as asthma and prurigo nodularis.

Jay Bradner, who serves as the executive vice president of research and development at Amgen, acknowledged the challenges faced by individuals with moderate-to-severe AD, highlighting the chronic and life-disrupting nature of their symptoms. Despite the availability of current treatments, many patients struggle to achieve or maintain their therapeutic goals. Bradner expressed satisfaction with the ROCKET programme results, emphasizing the promising potential of rocatinlimab as a new treatment alternative.

The ROCKET programme is further supported by favorable outcomes from the SHUTTLE and VOYAGER studies, according to the companies. Future investigations, such as the ASCEND trial, are set to explore the effects of rocatinlimab beyond the 24-week period. Additionally, the ASTRO and ORBIT trials are geared towards evaluating the drug's efficacy in adolescents.

Takeyoshi Yamashita, senior managing executive officer and chief medical officer at Kyowa Kirin, emphasized that these findings contribute to understanding rocatinlimab's comprehensive profile and its capacity to inhibit and diminish pathogenic T cells.