Medincell’s Post

Boehringer Ingelheim and Click Therapeutics, Inc. announce FDA Breakthrough Device Designation for Schizophrenia Prescription Digital Therapeutic (PDT) >> 📲The pair announced the FDA designation for their PDT, CT-155, designed to treat negative symptoms of schizophrenia. 📲CT-155, accessible on mobile devices, is being studied for use alongside standard pharmaceutical therapy, marking a novel dual pronged approach in treating schizophrenia 📲Schizophrenia, a leading cause of disability worldwide, affects around 24 million people and is associated with high societal costs 📲Existing antipsychotic medications primarily address positive symptoms of schizophrenia, while negative symptoms, which strongly impact cognitive function, remain inadequately treated 💬The CT-155 program, has met all development milestones since 2020, good news for Click Therapeutics as the milestone contingent deal is worth $500 Million (plus royalties) 💬Assuming full commercialisation it will be interesting to see how often this is prescribed as a standalone treatment or with competitor / generic drugs vs being tightly tied to Boehringer’s own drug treatment 👇Link to release in comments below #DigitalHealth #DTx

NEW RESEARCH ALERT! Crystal Research Associates released a 52-page EIO on Delpor, Inc. (Closely Held), a clinical-stage biopharmaceutical company developing once-yearly therapeutic products to treat chronic conditions. The Company’s unique and patented Prozor™ technology facilitates the release of specific insoluble drugs, such as most antipsychotics, from a non-mechanical (passive) implantable drug delivery device (which is the length of a matchstick). This device is placed under the skin in the abdomen and employs a distinct formulation to allow for the consistent release of medications. The placement procedure for the device is brief, typically lasting only 10 minutes, and is conducted in a physician’s office under local anesthesia. This enhances medication adherence, efficacy, safety, treatment outcomes, and patient quality of life. Delpor’s clinical assets include a 6-12-month formulation of risperidone (DLP-114) for schizophrenia treatment as well as a 6-12-month formulation of naltrexone (DLP-160) for Opioid Use Disorder (OUD) and alcohol dependence treatment. Also in development are earlier stage preclinical candidates, with a 6-month drug formulation of tizanidine (DLP-208) for moderate to severe spasticity, as well as compounds for Parkinson’s, Alzheimer’s, and more. Delpor thinks of its technology as ‘a once-a-year cure for an incurable disease.’ Check out our report to learn more about the Company. | https://bit.ly/3Kn5660 #Delpor #antipsychotics #schizophrenia #opioidusedisorder #spasticity #obesity #dementia #Parkinsons #Alzheimers #Crohns #zeroorderreleasepharmacokinetics

Major update in pharmaceutical innovation this weekend 🗣️ Lykos Therapeutics announces the FDA's acceptance of their New Drug Application for MDMA capsules for PTSD treatment, with a priority review set for August 11, 2024. This step could introduce the first MDMA-assisted therapy, marking a substantial advancement in this area of mental healthcare. "Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD," states Amy Emerson, CEO of Lykos Therapeutics. "We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved." Backed by successful Phase 3 studies, this therapy represents a potential shift in treating the debilitating condition, meeting the critical need for new, effective PTSD therapies after two decades without FDA-approved drug advancements.💊 What do you think? How might this influence the future landscape of mental health treatment and societal perceptions of PAT? Read the press release: https://lnkd.in/g-bm6gmM

Vertex Pharmaceuticals has suspended its VX-880 diabetes drug trial following two fatalities, emphasizing that the incidents are unrelated to the treatment. The company is committed to transparency and patient safety, conducting a thorough review in collaboration with regulators. Despite the setbacks, Vertex maintains that the safety profile of VX-880 aligns with immunosuppressive drugs. VX-880 is an allogeneic, stem cell-derived therapy designed to stimulate insulin production in islet cells, currently undergoing a phase 1/2 study for individuals with type 1 diabetes. https://lnkd.in/ddzQGwMb #VertexPharmaceuticals #VX880 #Diabetes #ClinicalTrials #healthcare #lifesciences

In this busy toolbox of topicals, orals and biologics for psoriasis, how do you pick the right agent for your patient? Join us in this engaging discussion where we walk you through the pros and cons of various therapies to help guide treatment decisions for your real world patients. Thank you to HCPLive for bringing us all together! I always learn something new when discussing the landscape with Mark Lebwohl, Jennifer Soung, and Saakshi Khattri! #psoriasis

Exciting developments in pain management: Vertex Pharmaceuticals' Phase 3 clinical trials reveal promising results for a non-addictive option targeting acute pain. Unlike opioids, Vertex's VX-548 focuses on peripheral nerves, potentially averting the feedback loop leading to dependency. A step forward in addressing the opioid epidemic. #painmanagement #chronicillness #chronicpain

In this BioSpace article I share my thoughts on the recent FDA Adcomm vote for Lykos Therapeutics’ #MDMA assisted therapy for #PTSD. Thanks Gail Dutton for the discussion.

Cybin Inc., a biopharmaceutical company specializing in psychedelic-based mental health treatments, has secured $150 million in funding to advance its clinical-stage programs, CYB003 and CYB004. CYB003, a deuterated psilocybin analog, has received Breakthrough Therapy Designation (BTD) from the FDA for the adjunctive treatment of Major Depressive Disorder (MDD). This designation recognizes CYB003’s potential to significantly improve treatment outcomes based on preliminary findings. A Phase 3 MDD study is expected to commence mid-2024. CYB004, a deuterated DMT program, is being developed for Generalized Anxiety Disorder (GAD). Results from a Phase 2 study are anticipated in Q4 2024 and will assess the drug’s efficacy, onset time, and durability of effects. Cybin’s pipeline also includes programs targeting treatment-resistant depression and obsessive-compulsive disorder. The company holds a substantial intellectual property portfolio, including over 50 granted and pending patents. Cybin’s CEO, Doug Drysdale, emphasized the growing need for improved mental health treatments and the company’s commitment to addressing the mental health crisis. He highlighted the recent BTD for CYB003 and the initiation of the Phase 2 study for CYB004 as key milestones. The funding round provides financial support for Cybin’s ongoing clinical programs and further development efforts. The company anticipates a transformative year ahead, with the initiation of the CYB003 Phase 3 trial and the release of CYB004 Phase 2 topline data. Cybin remains focused on developing innovative psychedelic-based therapies to revolutionize the treatment of mental health disorders.