Innovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline

Otsu­ka launch­es piv­otal tri­al of dig­i­tal ther­a­peu­tics for depres­sion (Med­C­i­ty News):

Otsu­ka Phar­ma­ceu­ti­cal is launch­ing a vir­tu­al study to see if dig­i­tal ther­a­peu­tics can reduce depres­sion symptoms.

It’s the next step in a part­ner­ship between the Tokyo-based drug­mak­er and Click Ther­a­peu­tics, a dig­i­tal health start­up that is devel­op­ing pro­grams for smok­ing ces­sa­tion, depres­sion and insomnia.

They plan to enroll up to 540 patients in a ran­dom­ized, con­trolled tri­al that will test the dig­i­tal therapeutic’s effi­ca­cy in patients that are tak­ing anti­de­pres­sants. The remote tri­al will be con­duct­ed using Verily’s Project Base­line platform…

“Specif­i­cal­ly, in men­tal health, we do think that dig­i­tal ther­a­peu­tics will pro­vide addi­tion­al ben­e­fits for patients and that’s the rea­son why we are not only inter­est­ed in one inter­ven­tion but also obvi­ous­ly are com­mit­ted to broad­en this with oth­er approach­es that are meant to improve the life of patients,” (Otsu­ka Chief Med­ical Offi­cer Christoph) Koe­nen said. “We do believe that the treat­ment land­scape in men­tal dis­ease is going to evolve in a way where obvi­ous­ly phar­ma­cother­a­py will always play a role, but we do think dig­i­tal ther­a­peu­tics can play an addi­tion­al role, and to some extent, sub­sti­tute as well as aug­ment phar­ma­co­log­i­cal intervention.”

The Announcement:

Otsu­ka and Click Ther­a­peu­tics Ini­ti­ate First-of-its-Kind Ful­ly Remote Clin­i­cal Tri­al Using Dig­i­tal Ther­a­peu­tics as Adjunc­tive Ther­a­py in Adults With Major Depres­sive Dis­or­der (press release):

Otsu­ka Phar­ma­ceu­ti­cal Devel­op­ment & Com­mer­cial­iza­tion, Inc. (Otsu­ka) and Click Ther­a­peu­tics, Inc. announce the ini­ti­a­tion of the Mirai study, a land­mark ful­ly remote clin­i­cal tri­al to inves­ti­gate the effec­tive­ness of dig­i­tal ther­a­peu­tics in reduc­ing depres­sive symp­toms in adults diag­nosed with major depres­sive dis­or­der (MDD) who are on anti­de­pres­sant monotherapy.

Otsu­ka and Click will col­lab­o­rate with Ver­i­ly, a sub­sidiary of Alpha­bet, to exe­cute the tri­al as a ful­ly remote tri­al. The col­lab­o­ra­tion with Ver­i­ly pro­vides tools and tech­nol­o­gy to engage patients and clin­i­cians, in order to increase the pace of stud­ies and col­lect high­er qual­i­ty, more com­pre­hen­sive data in a more nat­u­ral­is­tic set­ting. The col­lab­o­ra­tion also enables the tri­al to pro­ceed effi­cient­ly and safe­ly in the face of the unique mar­ket chal­lenges pre­sent­ed by COVID-19.

News in Context:

• Otsu­ka Phar­ma and Click Ther­a­peu­tics enter part­ner­ship poised to trans­form men­tal healthcare
• Click Ther­a­peu­tics rais­es $30 mil­lion in debt to advance com­mer­cial­iza­tion of smok­ing ces­sa­tion app Clickotine
• UCLA launch­es major men­tal health study col­lect­ing & ana­lyz­ing data from Apple wear­ables to bet­ter under­stand depres­sion and anxiety