AOB Pharma has signed an exclusive license and development agreement with Maruho for the development and marketing of its topical biologic, B244, for inflammatory indications in Japan.
B244, which is presently being readied for international Phase III clinical trials, is a therapeutic treatment aimed at inflammatory indications such as atopic dermatitis, addressing both appearance and pruritus (itch).
The agreement grants Maruho exclusive rights to commercialise the product in Japan for all indications treated by the product.
AOB will be responsible for supplying B244 to Maruho.
The company will receive an upfront payment from Maruho in addition to further additional milestone payments on meeting development and commercialisation goals and royalty payments.
Maruho also secured the rights to B244 for all further indications, including later-stage programmes linked to inflammation.
AOB is currently planning to commence international Phase III clinical trials of B244 in atopic dermatitis, with subject recruitment anticipated to begin in the second half of this year.
Maruho will conduct the Japanese portion of the Phase III trials.
Maruho president and CEO Atsushi Sugita said: “B244 offers an opportunity to extend our portfolio for the treatment of Atopic Dermatitis as well as other inflammatory indications.
“It’s unique safety profile and efficacy will allow us to continue our leadership in treating Atopic Dermatitis while improving patients’ lives. We look forward to continuing to develop the treatment in collaboration with AOB Pharma.”
A patented topical formulation, B244 platform produces nitric oxide upon application.
Nitric oxide is a signalling molecule claimed to control vasodilation and inflammation.
Clinical studies so far have shown that B244 is well-tolerated.
Recent immunology data indicated that the product could cut down inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31.
AOB Pharma president and CEO Todd Krueger said: “We view this as validation of B244’s potential to address unmet market needs, not just in Japan but globally.
“We could not have found a better collaborator as we develop our programmes for Japanese patients. This model will serve as an example as we fill out our worldwide strategy.”