Habit Spasms

SciSparc to conduct trial at Yale University in the USA, Tel Aviv Sourasky Medical Center in Israel and the Hannover Medical School in Germany TEL AVIV, Israel, Nov. 10, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced the initiation of its Phase IIb clinical trial treating patients suffering from Tourette Syndrome (TS) with its SCI-110, proprietary drug candidate. The trial is being conducted under the regulation of the U.S. Food and Drug Administration (FDA), the Federal Institute for Drugs and Medical Devices in Germany (BfArM) and the Israeli Ministry of Health. SciSparc initiated the trial at the Tel Aviv Sourasky Medical Center in Israel (Sourasky) and is expected to proceed with its U.S. and Germany-based medical sites. The Company has already secured institutional review board approval from all three clinical sites, approval from the Israeli Ministry of Health for the clinical trial at Sourasky, and approval from BfArM for conducting the trial at the Hannover Medical School. TS is a movement and neurobehavioral disorder characterized by motor and vocal tics and is highly linked with co-morbidities. As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, there is a clear unmet medical need for the management of TS. SCI-110 contains Dronabinol (FDA approved synthetic form of THC), with the endocannabinoid palmitoylethanolamide (PEA). Designed to stimulate cannabinoid receptors across the central nervous system and inhibit the metabolic degradation of endocannabinoids in order to improve uptake of THC, the expected benefits of SCI-110 are more efficient through oral administration, and in turn a decrease in dosage requirements, side effects and adverse events. The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between 18 and 65 years of age) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups. Results from the Company's Phase IIA clinical trial conducted at Yale University demonstrated an average tic reduction of 21% across the entire sample with almost 40% of the patients experiencing greater than 25% in tic reduction as defined by YGTSS-TTS (a clinician-rated instrument considered as the gold standard for assessing tics in patients with TS). In addition, the medication was generally well-tolerated by subjects and 12 out of the 16 subjects elected to continue into a 24-week extension phase of the trial. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on the Amazon.com Marketplace. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses: the trial’s objective to evaluate efficacy, safety and tolerability of SCI-110; and the trial is expected to proceed with its U.S. and Germany-based medical sites. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on May 1, 2023, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Investor Contact: IR@scisparc.com Tel: +972-3-6167055

-- National direct-to-patient program allows patients and caregivers to obtain DYANAVEL XR extended-release tablet prescriptions from digital pharmacy -- MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)-- Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced a new partnership with Perigon Pharmacy 360, a full-service, specialty digital pharmacy, to enhance accessibility, affordability and adherence for patients treating symptoms of ADHD with Tris’ DYANAVEL® XR (amphetamine) extended-release tablets. Together, Tris Pharma and Perigon launched a direct-to-patient program, DYANAVEL Delivered, that allows patients and caregivers to seamlessly access DYANAVEL XR extended-release tablets through Perigon’s digital pharmacy, enhance their medication management, and receive reimbursement assistance and support to help navigate their treatment journey while reducing administrative burden for both patients and providers. The program is available across the United States, enabling nationwide access to DYANAVEL XR extended-release tablets. Patients and physicians wishing to access the DYANAVEL Delivered program can learn more at . “This partnership underscores our continued commitment to ensuring patients have access to the medications they need to treat their ADHD symptoms,” said Ketan Mehta, founder and CEO at Tris Pharma. “In an environment where shortages have been significant and widespread for more than a year, Tris Pharma is among the relatively few companies that have managed to not only maintain but increase supply of our ADHD medications without interruption. Our program with Perigon builds on this success by offering patients a more convenient way to consistently obtain access to their DYANAVEL XR extended-release tablet prescription.” Since the November 2021 approval of DYANAVEL XR extended-release tablets, Tris Pharma has seen a consistent increase in prescription volume and taken steps to manage manufacturing volume to ensure that the company is able to consistently meet and exceed demand. The DYANAVEL Delivered program is designed to help eliminate bottlenecks by delivering DYANAVEL XR extended-release tablets directly to patients and caregivers. “We’re incredibly excited to partner with Tris Pharma on this program, because we believe it has the potential to enhance quality of care and reduce prescription access challenges for ADHD patients during a particularly critical time,” said Ted Mills, CEO at Perigon Pharmacy 360. “Additionally, this partnership will provide important insights about the impact of innovative technology and advanced healthcare solutions on real-world patient outcomes.” DYANAVEL XR extended-release tablets are approved for the treatment of ADHD in patients aged 6 years and older. This medication is developed using Tris Pharma’s proprietary LiquiXR® technology to create a non-degrading diffusion coating that offers a consistent, controlled release of medication over time. DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep DYANAVEL XR in a safe place to protect it from theft. Never give your DYANAVEL XR to anyone else because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law. See additional important safety information below. About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at and on LinkedIn @TrisPharma. About Perigon Pharmacy 360 Perigon Pharmacy 360 is an independent specialty pharmacy that is working to provide care and support to those in need. Perigon serves patients in all 50 states, plus D.C., and are focused on helping improve the patient experience through access to medications, caregiver awareness, provider engagement, and clinical support of our Care Teams. Perigon also utilizes the proprietary Medesto platform, together with the specialty and traditional care pharmacy, to create a Precision Digital Pharmacy model with the goal of improving medication adherence and, clinical outcomes. Perigon Pharmacy 360 is redefining the manner in which patients interact with the critical role of the Pharmacist. For more information, please visit INDICATION DYANAVEL XR is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older. IMPORTANT SAFETY INFORMATION WARNING: ABUSE, MISUSE, AND ADDICTION DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction. DYANAVEL XR is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported with other amphetamines. in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of increased risk of hypertensive crisis. Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with DYANAVEL XR, assess for the presence of cardiac disease. Avoid DYANAVEL XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment. CNS stimulants cause increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension. Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce maniac or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating DYANAVEL XR treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with DYANAVEL XR. Treatment may need to be interrupted in children not growing as expected. CNS stimulants, including DYANAVEL XR, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for DYANAVEL XR-treated patients who develop signs or symptoms of peripheral vasculopathy. Serotonin syndrome risk is increased when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment. CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating DYANAVEL XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor DYANAVEL XR-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate. Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction pro DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%). DYANAVEL XR use during pregnancy may cause fetal harm. To monitor pregnancy outcomes in women exposed to DYANAVEL XR during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at . Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with DYANAVEL XR. To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or . Please see Full Prescribing Information, including Boxed Warning regarding ABUSE, MISUSE, AND ADDICTION. DYANAVEL® and LiquiXR® are registered trademarks of Tris Pharma, Inc.

Initiation of trial to take place at the Tel Aviv Sourasky Medical Center, the Israeli clinical trial site TEL AVIV, Israel, Sept. 07, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced the initiation of its Phase IIb Clinical Trial for its proprietary SCI-110 for the treatment of Tourette Syndrome (“TS”) at the Tel Aviv Sourasky Medical Center in Israel (“Sourasky”). The trial is based on the positive data results received from the single arm Yale School of Medicine study using SCI-110 for TS. "The initiation of our Phase IIb Clinical Trial at Sourasky, the Israeli site, is a major milestone towards commercializing our proprietary SCI-110 for TS patients. TS in adults can be a debilitating disorder for which current treatments result in limited benefits. Encouraged by the results seen in the Phase IIa study at Yale School of Medicine, we look forward to continuing clinical research of the treatment regimen in this double-blind randomized trial," said SciSparc’s Chief Executive Officer, Oz Adler. "This is an important area of growth for the Company, alongside the Company’s other proprietary platforms, including SCI-110 in patients with Alzheimer’s disease and agitation and SCI-210 for children suffering from autism spectrum disorder." The Phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, USA, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel. The Company has already secured the Institutional Review Board approvals from all three clinical sites, the Israeli Ministry of Health's approval for the clinical trial at Sourasky, and approval from the Federal Institute for Drugs and Medical Devices in Germany for conducting the trial at the Hannover Medical School. The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between 18 and 65 years of age) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on the Amazon.com Marketplace. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses that the initiation of the Phase IIb Clinical Trial at Sourasky is a major milestone towards commercializing SCI-110 and continuation of the clinical research of the treatment regimen in this double-blind randomized trial, that this is an important area of growth for the Company, alongside the Company’s other proprietary platforms. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on May 1, 2023, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Investor Contact: IR@scisparc.com Tel: +972-3-6167055