CELL AND GENE THERAPY, MEDTECH
Pear Therapeutics | January 09, 2023
Pear Therapeutics, Inc., the leader in commercializing and developing software-based medicines known as prescription digital therapeutics (PDTs), announced the expansion of its collaboration with Spero Health, an integrated healthcare services organization.
Spero Health, which has adopted reSET® and reSET-O® at 14 locations in Kentucky, plans to expand access to eligible patients at its remaining 99 locations in Kentucky, Indiana, Ohio, Tennessee, Virginia, and West Virginia. Offering new FDA-approved treatment options is a part of Spero Health's mission to promote patient engagement and retention in recovery.
Steve Priest, Spero Health’s CEO said, “Spero Health continues to find innovative ways with new technologies to bring solutions to our communities that have been devastated by drug overdose, and we are looking forward to our collaboration with Pear Therapeutics to pursue even better outcomes in treatment.”
Adding to this, he further said, “Pear’s technology equips our clinicians with vital measurements via a clinician dashboard that allows us to provide quality care to our patients who suffer from substance use disorders. We believe having access to patient reported data via Pear’s clinician dashboard gives us better insight into patient behaviors. We expect that this approach will help to increase compliance and create efficiencies in how our treatment teams deliver care.” (Source: BusinessWire)
Spero Health's two implemented products, reSET® and reSET-O®, have been measured in real-world use, and their therapeutic content has been evaluated in randomized controlled trials, with the results published in peer-reviewed medical journals. reSET® is used for patients aged 18 or older with substance use disorder as a monotherapy, whereas reSET-O® is used in combination with buprenorphine-based medication-assisted treatment for patients 18 and older with opioid use disorder.
About Pear Therapeutics
Pear Therapeutics, Inc., the parent firm of Pear Therapeutics (US) Inc., is a leader in the development and marketing of software-based pharmaceuticals, also known as prescription digital therapeutics (PDTs). The company intends to transform care through the widespread adoption of clinically validated software-based therapeutics to provide improved patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.
MEDTECH, INDUSTRIAL IMPACT
Arcutis Biotherapeutics, Inc. | December 20, 2022
Arcutis Biotherapeutics, Inc. an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration for the expanded indication of ZORYVE cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11. As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.
ZORYVE was approved by the FDA in July 2022 for the topical treatment of plaque psoriasis in adults and adolescents 12 years of age and older. ZORYVE is a steroid-free, topical PDE4 inhibitor which effectively clears plaque psoriasis in both hard-to-treat areas such as knees and elbows, as well as sensitive areas such as the face, intertriginous areas, and genitalia.
“Safety and tolerability are critically important in the treatment of children, and today young children lack treatment options for plaque psoriasis. This submission is an exciting step in our efforts to expand the availability of an effective, steroid-free treatment for children with plaque psoriasis,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. “ZORYVE is the first PDE4 approved for the treatment of psoriasis and, if approved by the FDA with the new data, dermatology clinicians will be able to treat patients down to 2 years of age.”
“ZORYVE demonstrated a favorable safety and tolerability profile in this pediatric population, with minimal local site reactions. ZORYVE, with our proprietary HydroARQ Technology™, is a non-greasy, moisturizing cream that spreads easily and is aesthetically pleasing to patients, and most importantly does not include sensitizing excipients or irritants such as propylene glycol,”
Frank Watanabe, President and CEO at Arcutis
The submission is based on data from two recently completed 4-week MUSE studies in children aged 2 to 11 years with plaque psoriasis. Pharmacokinetic, safety, tolerability, and efficacy data from these two studies are consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials. Arcutis worked with the FDA on the design of the MUSE studies, which are intended to fulfill FDA post-marketing requirements for ZORYVE.
ZORYVE cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
Arcutis Biotherapeutics, Inc. is an early commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata.
MEDTECH, INDUSTRIAL IMPACT
ATUM and Codiak | January 25, 2023
On January 24, 2023, ATUM, a global leader in bioengineering solutions, announced that it has signed a comprehensive licensing agreement with Codiak BioSciences, a clinical-stage biopharmaceutical company, for the Leap-In Transposase® technology.
ATUM will grant Codiak access to its Leap-In Transposase® technology in order to create mammalian cells expressing exosomes engineered to deliver therapeutic payloads under the conditions of the agreement. The Leap-In technology is a comprehensive solution that integrates patented re-coding algorithms, unique genetic vector elements, and a transposon-based mechanism for efficiently inserting genetically stable elements into the genome.
"Through years of rigorous research and clinical validation we have created a platform for engineering and manufacturing therapeutic exosomes with various payloads on the surface or inside the lumen. We believe ATUM's transposase technology has the potential to effectively synergize with Codiak's engEx® Platform to further enhance loading these vesicles, making them more potent and reducing cost of goods," Commented Scott Estes, Ph.D., VP of Cell Line Development at Codiak.
(Source – Business Wire)
"Exosomes are bio vesicles that have the potential to fundamentally change drug delivery. We are proud and excited to license the Leap-In Transposase® technology to Codiak for the engineering of cell lines that enables rapid and robust production of exosomes," said Claes Gustafsson, Ph.D., Chief Commercial Officer and Co-Founder at ATUM.
(Source – Business Wire)
Founded in 2015, Codiak is a clinical-stage biopharmaceutical firm focused on developing exosome-based treatments, a new class of medications with the potential to change the treatment of a variety of diseases with high unmet medical needs. It created a proprietary engEx Platform that uses exosome biology as natural intercellular transfer mechanisms to design, construct, and manufacture innovative exosome therapeutic candidates. By utilizing its engEx Platform, it has produced a rich pipeline of engineered exosomes for neuro-oncology, oncology, neurology, neuromuscular, and infectious diseases.