Courier Alzheimer's Disease Drug Phase 2 Interim Clinical Results Positive! Significant improvement in agitation symptoms

SciSparc today announced the positive interim results of
a Phase 2a trial of its drug SCI-110 in the treatment of Alzheimer's disease (AD) patients with agitated symptoms.
According to the data, the drug has a good safety profile and significantly improves agitation symptoms
in AD patients.

AD is an irreversible neurodegenerative disease in which patients experience progressive impairment of cognitive function, including impairment of multiple cognitive functions, including memory, comprehension, language function, attention, reasoning, and judgment
.
In addition, patients with AD often present with neuropsychiatric symptoms such as apathy, social avoidance, agitation, confusion, insomnia, and loss
of appetite.
Among the above symptoms, agitation manifests itself in almost all AD patients, increasing the patient's pain and medical burden
.

SCI-110 is one of SciSparc's innovative drug portfolios based on cannabinoids, leveraging its proprietary technology, which SciSparc has created to enhance the efficacy
of different cannabinoids.
In preclinical studies, SCI-110 has improved efficacy, with significantly lower
dose requirements and drug-related side effects compared to cannabinoids alone.

The published clinical trial is an open-label study of 20 AD patients with agitated symptoms who received oral SCI-110 twice daily to evaluate trends in safety, tolerability, and efficacy
.
The results of the interim analysis summarized data
from the first 8 patients who completed the study.

In the interim analysis, the study met the primary endpoint of safety, including adverse events unrelated to treatment and patients
who withdrew from the study.
Specifically, SCI-110 did not cause delirium, excessive sedation, hypotension, or falls
even at the highest dose (12.
5 mg dronabinol + 400 mg PEA).

Image source: 123RF

In addition to advances in safety, the study also met a secondary endpoint of change in agitated behavior from baseline to the end of treatment by the Cohen-Mansfield Agitation Questionnaire (CMAI), in which 6 of the 8 patients experienced an improvement in agitation behavior that did not require the use of rescue
medications.

In terms of exploratory endpoints, the researchers assessed participants using the Edinburgh Feeding Evaluation in Dementia Scale and showed increased appetite
in 6 out of 8 patients 。 In addition, the researchers further evaluated the mental state and cognitive ability of subjects based on the Mini Mental State Exam, Alzheimer's Disease Assessment Scale-cognitive Subscale and Pittsburgh Sleep Quality Index.
Participants were found to have no effect
on cognition and sleep quality.

Overall, SCI-110 was well tolerated, no adverse effects of treatment with participants were observed during the study period, and participants received 32 days of treatment and 7 days of follow-up after discontinuation up to the data cut-off
date.

Image source: 123RF

Dr.
Adi Zuloff-Shani, Chief Technology Officer of SciSparc, said in a press release: "We are pleased that SCI-110 has shown clinically meaningful results and that it holds the potential for a potential treatment
option for Alzheimer's patients with agitated symptoms.
These results further support our efforts to reimagine medicine in this challenging field and work for patient populations whose medical needs are not adequately met
.
”

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