PHARMATHER HLDGS LTD - PHRRF STOCK NEWS

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted a pre-Investigational New Drug meeting request to the FDA for its KETABET™ treatment, aimed at addressing major depressive disorder. The company seeks to leverage the FDA's 505(b)(2) pathway and Fast Track designation for KETABET™, which combines ketamine with betaine anhydrous to enhance antidepressant effects while reducing side effects. Additionally, PharmaTher is developing a hydrogel-forming microneedle patch for convenient drug delivery, promising improved patient compliance and therapeutic outcomes.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) is advancing its clinical-stage psychedelics initiatives with three key studies in 2021. The FDA has accepted an IND for a Phase 2 clinical trial using ketamine to treat Parkinson's disease, with patient enrollment expected in Q3-2021 and results in Q4-2021. Additionally, PharmaTher is preparing for a Phase 2 study on KETABET™ for treatment-resistant depression and is finalizing a Phase 2 design for ALS treatments. Upcoming developments include innovative microneedle delivery systems for psychedelics, aimed to enhance efficacy and patient compliance.

PharmaTher Holdings Ltd. and TSRL, Inc. have entered into a Co-Development Agreement to create a microneedle array patch aimed at enhancing delivery methods for both psychedelics and antiviral drugs. This collaboration leverages patented hydrogel-forming technology from Queens University and focuses on improving drug safety, efficacy, and patient compliance. TSRL’s experience in drug development complements PharmaTher’s psychedelic research efforts. Both companies anticipate expedited clinical and commercial development, potentially expanding their market opportunities.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has formed a collaboration with MediSynergics, LLC to develop patented ketamine derivatives aimed at treating pain and CNS disorders. Initial research shows these derivatives could potentially offer better efficacy and fewer side effects than traditional ketamine, making them suitable alternatives to opioids. The partnership also aims to explore next-generation psychedelics like psilocybin and DMT. PharmaTher is currently in a Phase 2 FDA study using ketamine to treat Parkinson's disease and is developing a microneedle patch for psychedelic delivery.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has filed an application with the FDA for Orphan Drug Designation for ketamine to treat amyotrophic lateral sclerosis (ALS). ALS, affecting around 50,000 in the U.S. and Europe, currently has no cure and a limited life expectancy post-diagnosis. Ketamine's promising preclinical research indicates it may preserve muscle function and increase life expectancy in ALS patients. If approved, ketamine could achieve over USD $1 billion in peak sales, offering significant incentives and marketing exclusivity to PharmaTher.

PharmaTher Holdings Ltd. (CSE: PHRM, OTCQB: PHRRF) has appointed Professor Matthew Macaluso, D.O. as a scientific and clinical advisor to enhance its clinical research programs focused on ketamine for treating major depressive disorders and ALS. With over ten years of experience in clinical trials, Macaluso's expertise includes leading over 60 trials involving treatment-resistant depression. His involvement aims to guide PharmaTher’s initiatives for regulatory approvals and clinical strategies, further developing ketamine's potential in neurology and psychiatry.

PharmaTher Holdings Ltd. announced FDA approval for its IND application to initiate a Phase 2 clinical trial of ketamine aimed at treating levodopa-induced dyskinesia in Parkinson’s disease patients. The trial will commence in Q3-2021 at up to eight sites across the U.S., enrolling 36 participants. The global market for Parkinson's treatment is projected to grow from $5 billion in 2019 to $7.5 billion by 2025, with the U.S. opportunity for this specific treatment exceeding $3 billion. CEO Fabio Chianelli emphasized the milestone as a step towards establishing PharmaTher as a leader in psychedelic-based therapeutics.

PharmaTher Holdings Ltd. (CSE: PHRM, OTCQB: PHRRF) has filed a provisional patent application for ketamine as a treatment for Type 2 diabetes and obesity, utilizing its AI platform, panaceAI™. The company is pursuing an IND application with the FDA for a Phase 2 trial of ketamine targeting Parkinson’s disease.

PharmaTher is also investigating other psychedelics like DMT, MDMA, and LSD for clinical development. The company aims to commercialize its findings through internal development or partnerships, enhancing its patent portfolio.

PharmaTher Holdings Ltd. announced the submission of an Investigational New Drug (IND) application to the FDA for a Phase 2 clinical trial examining low-dose ketamine's efficacy in treating levodopa-induced dyskinesia in Parkinson’s disease patients. This application marks a significant milestone for the company in its efforts to commercialize ketamine. The trial aims to enroll 36 subjects across multiple U.S. sites, with the primary endpoint being the change in the Unified Dyskinesia Rating Scale total score after 8 weeks. A positive trial outcome may lead to a pivotal Phase 3 study.