Pear Therapeutics announced the first patient dosed in part II of the first clinical study evaluating Pear-006, a digital therapeutic product candidate for addressing depressive symptoms in Multiple Sclerosis (MS).
The randomized controlled trial will enroll approximately 30 patients with Relapsing MS for eight weeks treatment with digital therapy and evaluate dosing, patient use, engagement, and other clinical outcomes.
Pear-006 is designed to deliver specific cognitive behavioral therapy, cognitive restructuring, and other neurobehavioral mechanisms of action, to address depressive symptoms in people with MS. Pear Therapeutics is developing Pear-006 in collaboration with Novartis under the terms of an agreement announced in March 2018.
“Between 35-50% of people with MS have symptoms of depression1, yet only inadequate treatment options remain to improve quality of life. Pear Therapeutics understands the importance of not only addressing this unmet need, but doing so in a way that would allow easy access for patients,” said Yuri Maricich, M.D., Chief Medical Officer at Pear Therapeutics. “As pioneers in prescription digital therapeutics, we take pride in leading the first decentralized trial for a digital therapeutic in this patient population, further exploring the potential of this novel therapeutic modality and advancing research for the MS community.”
Prescription digital therapeutics represent a new treatment class in healthcare that blend the iterative design and development agility of software and deliver scientific mechanisms of action which are developed with scientific rigor and evidence-based process required by the FDA for class II A medical devices. Pear-006 has been developed based on valuable insights from patients, scientists and neurologists.
The study began with a part I feasibility study in May 2019, which reported encouraging findings, and further studies on efficacy will be pursued next pending the outcomes of this trial.
Source: Company Press Release