dronabinol/palmitoylethanolamide (SCI-110) / SciSparc - LARVOL DELTA

Therapeutic potential of cannabinoids for treating atopic dermatitis. (PubMed, J Cannabis Res) - "Studies suggest that phytocannabinoids such as cannabidiol (CBD) and Δ-9-tetrahydrocannabinol (THC), along with endogenous and synthetic compounds such as palmitoyletanolamide (PEA) and dronabinol, can improve AD symptoms, primarily because of their anti-inflammatory, antipruritic and antioxidant properties. Additionally, some cannabinoids exhibit antimicrobial effects. Despite these promising results, the use of cannabinoids in AD treatment requires further investigation to better understand their efficiency and safety, necessitating high-accuracy clinical and preclinical trials."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

SciSparc Submitted IND Application to the FDA for SCI-110 Phase IIb Clinical Trial for Patients with Tourette Syndrome (GlobeNewswire) - "SciSparc...announced the submission of an Investigational New Drug ('IND') application with the U.S. Food and Drug Administration ('FDA') for its phase IIb clinical trial for its proprietary SCI-110 for the treatment of Tourette Syndrome ('TS')....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, United States, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel ('Sourasky')....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 the ages of 18 and 65 years) 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."

IND • New P2b trial • Tourette Syndrome

SCI-110 in the Treatment of Tourette Syndrome (clinicaltrials.gov) - P2 | N=164 | Not yet recruiting | Sponsor: SciSparc

Trial completion date • Trial primary completion date • Movement Disorders • Tourette Syndrome

SciSparc Celebrates Major Breakthrough: Positive Results Show its Treatment has a Remarkable Impact on Alzheimer's Agitation (GlobeNewswire) - P2a | N=20 | NCT05239390 | "SciSparc Ltd...unveiled positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (IMCA). The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated....The results not only met primary endpoints regarding tolerability and adverse events but also demonstrated SCI-110's potential to alleviate agitation without side effects."

P2a data • Alzheimer's Disease • CNS Disorders

SciSparc Announces Successful Final Phase IIa Results, Meeting End Points of its Phase IIa Alzheimer Disease Patients with Agitation Trial (GlobeNewswire) - P2a | N=20 | NCT05239390 | "SciSparc Ltd...announced positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center ('IMCA'), which suggest that the Company’s proprietary SCI-110 is safe and tolerable while significantly improving agitation symptoms over time in elderly population with Alzheimer disease ('AD') and agitation....Results showed that the trial met its primary endpoints of the number of drop-out subjects' due to poor tolerability and the number of trial treatment (SCI -110) related adverse events, with no SCI-110 related safety issues observed and no dropouts from the trial due to trial medication."

P2a data • Alzheimer's Disease • CNS Disorders

SciSparc Completed Treatment of Last Patient Enrolled for its Phase IIa Clinical Trial for Alzheimer’s Disease and Agitation (GlobeNewswire) - "SciSparc Ltd...announced that the last patient enrolled in the Company's Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease ('AD') and agitation, completed its treatment. The Company is expecting to receive the final trial results in the upcoming weeks. On November 7, 2022, the Company announced positive interim results from the open label trial, which includes 20 patients diagnosed with AD and agitation, to evaluate the safety, tolerability and efficacy trends of twice daily oral administration of SCI-110. The interim results summarize the data from the first eight patients who completed the trial as per protocol."

P2 data • Trial status • Alzheimer's Disease • CNS Disorders

SciSparc Receives Final Approval to Commence its Phase IIb Clinical Trial for SCI-110 to treat Tourette Syndrome (GlobeNewswire) - "SciSparc...today announced it has been granted final approval from the Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, required to commence the Company’s Phase IIb Clinical Trial for SCI-110 to treat Tourette Syndrome....'We are thrilled to launch our Phase IIb Clinical Trial in Israel and start enrollment of patients suffering from Tourette Syndrome. This trial is a key milestone in SciSparc's pursuit of lower-dose, THC-based treatment that is potentially safer and more effective for patients than all the current available treatments.'"

New P2b trial • CNS Disorders • Tourette Syndrome

SCI-110 in the Treatment of Tourette Syndrome (clinicaltrials.gov) - P2 | N=164 | Not yet recruiting | Sponsor: SciSparc | Trial primary completion date: Mar 2024 ➔ Jun 2024

Trial primary completion date • Movement Disorders • Tourette Syndrome

SciSparc Announced Positive Interim Results Meeting Primary Endpoints at Phase IIa Study in Alzheimer’s Disease Patients with Agitation (GlobeNewswire) - P2a | N=20 | NCT05239390 | Sponsor: The Israeli Medical Center for Alzheimer's | “SciSparc Ltd…announced positive interim results from its Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (‘AD’) and agitation….At the interim analysis, the study met its primary endpoints of safety, including non-treatment related adverse events and drop out patients from the study; specifically, SCI-110 did not cause delirium, oversedation, hypotension or falls even in the highest dose tested (12.5MG Dronabinol+400mg PEA)….In addition, the interim analysis showed that the study also met its secondary endpoint of Change from Baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (‘CMAI’); out of the eight patients, six showed amelioration in agitation with no need to use rescue medication to control agitation."

P2a data • Alzheimer's Disease • CNS Disorders

SciSparc Signs Clinical Trial Agreement with Yale University to Conduct its Phase IIb Trial in Tourette Syndrome (GlobeNewswire) - "SciSparc Ltd...today announced the addition of another site of excellence, the Yale Child Study Center at Yale University, to its Phase IIb clinical trial for SCI-110 in patients suffering from Tourette Syndrome ('TS')....Yale University is the third medical center to join SciSparc’s multi-national, multi-center trial. Previously, SciSparc announced the Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center in Tel Aviv, Israel as medical center trial sites of excellence." "

Trial status • CNS Disorders • Tourette Syndrome

SciSparc Successfully Completed The Development of its Proprietary Drug Candidate SCI-110 for its Upcoming Phase IIb Study In Tourette Syndrome (GlobeNewswire) - "SciSparc Ltd...announced that it has successfully completed the development of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multicenter, Phase IIb study for Tourette Syndrome ('TS')....SCI-110 is developed and manufactured by Procaps Group S.A., a leader in contract development and manufacturing services in soft-gel advanced technologies for the global pharmaceutical industry."

Commercial • New P2b trial • CNS Disorders • Tourette Syndrome

SciSparc Announces Ethics Committee Approval to Conduct a Phase IIb Trial in Tourette Syndrome (GlobeNewswire) - "SciSparc Ltd...announced it received Ethics Committee approvals from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel, to conduct the Company’s Phase IIb clinical study for SCI-110 in patients suffering from Tourette Syndrome ('TS'). The Company is evaluating additional clinical sites to join the Phase 2b trial to expedite patient enrollment in a timely manner....The objective of this Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over study 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). The patients will be randomized in a 1:1 ratio to receive either SCI-110 or SCI-110 matched placebo. The primary efficacy objective of the study will be to assess tic severity change using Yale Global Tic Severity Scale (YGTSS-R-TTS)..."

New P2b trial • CNS Disorders • Tourette Syndrome

SCI-110 in the Treatment of Tourette Syndrome (clinicaltrials.gov) - P2 | N=164 | Not yet recruiting | Sponsor: SciSparc | N=86 ➔ 164 | Trial completion date: Feb 2024 ➔ Oct 2024 | Initiation date: Feb 2022 ➔ Sep 2022 | Trial primary completion date: Aug 2023 ➔ Mar 2024

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Movement Disorders • Tourette Syndrome

SciSparc Announces Recruitment of First Patient for its Phase IIa Clinical Trial in Alzheimer's Disease (PRNewswire) - “SciSparc Ltd…announced that The Israeli Medical Center for Alzheimer's has recruited the first patient to participate in the Company's Phase IIa clinical trial that will evaluate the safety, tolerability and efficacy of SCI-110 in patients with Alzheimer's disease and agitation using the Company's proprietary cannabinoid-based technology. The trial's primary objective is evaluating the safety of SCI-110 and the secondary objective is evaluating the ability of the compound to ameliorate agitation and other behavioral disturbances in patients with Alzheimer's disease.”

Trial status • Alzheimer's Disease • CNS Disorders

SCI-110 in the Treatment of Tourette Syndrome (clinicaltrials.gov) - P2; N=86; Not yet recruiting; Sponsor: SciSparc

Clinical • New P2 trial • Movement Disorders • Tourette Syndrome

Modeling the Percutaneous Absorption of Solvent-Deposited Solids Over a Wide Dose Range. (PubMed, J Pharm Sci) - "J Pharm Sci 110:2149-56)...The model allows one to describe on a mechanistic basis why the percutaneous absorption rate of NA is approximately 60-fold lower than that of its lower melting, more lipophilic analog, MN. It furthermore suggests that MN perturbs stratum corneum barrier lipids and increases their permeability while NA does not, presenting a challenge to molecular modelers engaged in simulating biological lipid barriers."

Journal

A Phase-2 Pilot Study of a Therapeutic Combination of Δ-Tetrahydracannabinol and Palmitoylethanolamide for Adults With Tourette's Syndrome. (PubMed, J Neuropsychiatry Clin Neurosci) - "Although the initial data from this trial in adults with refractory Tourette's syndrome are promising, future randomized double-blind placebo-controlled trials are necessary to demonstrate efficacy of THX-110 treatment. The challenges raised by the difficulty in blinding trials due to the psychoactive properties of many cannabis-derived compounds need to be further appreciated in these trial designs."

Clinical • Journal • P2 data • CNS Disorders • Mental Retardation • Psychiatry • Tourette Syndrome

Hemp extract, Alzheimer’s anxiety treatment start phase 2 clinical trial [Google translation] (Dementia News) - “Recently, SciSparc announced a phase 2 clinical trial plan for SCI-110 developed by SciSparc. SCI-110 is a medicinal product based on hemp extract…The company believes that SCI-110, which is composed of cannabinoids, a hemp extract, can improve psychological symptoms by binding to receptors along the central nervous system composed of the brain and spinal cord. Phase 2 clinical trials will evaluate safety and the ability to control agitation and other behavioral disorders in Alzheimer's patients.”

New P2 trial • Alzheimer's Disease • CNS Disorders • Dementia

SciSparc to Commence Phase IIa Clinical Trial of SCI-110 for the Treatment of Alzheimer's Disease and Agitation (PRNewswire) - “SciSparc…announced it has received approval from the Israeli Ministry of Health and Helsinki Committee to commence a Phase IIa Clinical Trial of SCI-110 (formerly THX-110) in patients with Alzheimer's disease (AD) and Agitation…The primary objectives of the Study are to demonstrate the safety of SCI-110 as well as its ability to ameliorate agitation and other behavioral disturbances in patients with AD.”

New P2a trial • Alzheimer's Disease • CNS Disorders • Psychomotor Agitation

SciSparc Announces Rebranding and Business Updates (PRNewswire) - ”SciSparc Ltd….today announced a series of rebranding processes….’We recently entered into an agreement with Procaps…to develop and commercially manufacture both our drug candidate, SCI-110 (formerly THX-110)’...As part of the rebranding, the company's clinical and pre-clinical programs were renamed as follows: SCI-110-An innovative and proprietary drug candidate…for the treatment of central nervous system diseases such as agitation in Alzheimer's, Tourette syndrome and obstructive sleep apnea.”

Commercial • CNS Disorders • Obstructive Sleep Apnea • Sleep Apnea • Sleep Disorder

SciSparc to Conduct a Phase IIa Clinical Trial in Alzheimer's Patients Using the Company's Proprietary Cannabinoid-Based Treatment (PRNewswire) - "SciSparc...today announced it has signed an agreement with The Israeli Medical Center for Alzheimer's, to conduct a phase IIa clinical trial to evaluate the safety, tolerability and efficacy of SCI-110 (formerly THX-110) in patients with Alzheimer's disease and agitation using the Company's proprietary cannabinoid-based technology....The study will be initiated immediately after receipt of all the required approvals from the Institutional Review Boards (IRB) and the Israeli Ministry of Health (MoH)."

Licensing / partnership • Alzheimer's Disease • CNS Disorders

Therapix Bio up 20% on encouraging THX-110 data in obstructive sleep apnea (SeekingAlpha) - "Thinly traded nano cap Therapix Biosciences (TRPX +20.1%) is up on a 14x surge in volume in reaction to positive results from a single-arm open-label study evaluating lead candidate THX-110 in adults with obstructive sleep apnea (OSA)."

Stock price

Therapix Biosciences announces positive topline results from phase IIa clinical trial of THX-110 for obstructive sleep apnea program (PRNewswire) - P2a, N=10; "Therapix Biosciences...announced today topline results from its Phase IIa clinical study at Assuta Hashalom Medical Center in Israel, suggesting that THX-110, a combination of dronabinol (∆ -9-tetrahydracannabinol, THC) and CannAmide™ (palmitoylethanolamide, PEA), positively affects symptoms in adult subjects with obstructive sleep apnea (OSA)."

P2a data

RespireRx Pharmaceuticals Inc. send notice letter to the board of directors of Therapix Biosciences Ltd (GlobeNewswire) - "RespireRx Pharmaceuticals...announces that it has sent a formal notice to the Board of Directors of Therapix Biosciences Ltd....Therapix has repeatedly made public statements that it intends to develop THX-110, a combination of dronabinol and PEA, for treating obstructive sleep apnea (OSA) in the United States and other markets....RespireRx Pharmaceuticals Inc (RespireRx) has licensed and is in possession of patents and patent applications for treating any sleep related breathing disorder..."

Patent

Effects of the glial modulator palmitoylethanolamide on chronic pain intensity and brain function (Dovepress) - P1, N=22; "PEA is effective at relieving NP. This reduction is coupled to a reduction in resting oscillations along the ascending pain pathway that are likely driven by rhythmic astrocytic gliotransmission."

P1 data