IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”),
a clinical-stage pharmaceutical company, today announced that it is
presenting 6 in-person posters highlighting data from its Phase 1
clinical trials investigating the Company’s lead therapeutic
candidate, IGC-AD1, at the Alzheimer’s Association International
Conference (“AAIC”) being held July 16-20, 2023, in Amsterdam,
Netherlands.
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the full release here:
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IGC Presenting Positive Impact of IGC-AD1
on Neuropsychiatric Symptoms in Dementia at the 2023 Alzheimer’s
Association International Conference (Photo: Business Wire)
IGC-AD1 is the only natural low-doses THC-based investigational
drug undergoing FDA trials. The therapy relies on low doses of THC
and another compound as active agents for the treatment of
neuropsychiatric symptoms associated with Alzheimer’s disease. It
has also shown in pre-clinical trials the potential to be effective
in ameliorating Aβ plaque, a key hallmark of Alzheimer’s. IGC-AD1
is currently in Phase 2 of clinical trials as a potential treatment
for agitation in dementia due to Alzheimer’s. According to
Alzheimer’s Disease International, the number of people living with
Alzheimer’s and other dementias is projected to nearly triple by
2050, with approximately 76% experiencing neuropsychiatric symptoms
like agitation. IGC expects that 13-15 trial sites can process
between 15 to 20 patients per month and is targeting completion of
its Phase-2 trial in the first quarter of calendar year 2024.
Ram Mukunda, CEO of IGC stated, “We are honored to have six
posters accepted for presentation at AAIC 2023, a prestigious
meeting of leading Alzheimer’s disease experts and pharmaceutical
innovators. The data being presented at AAIC from our Phase 1
clinical trial of IGC-AD1 demonstrates the positive impact of our
patented cannabinoid formulation on neuropsychiatric symptoms such
as agitation, apathy, and the associated caregiver distress,
without causing suicidal ideation or increasing blood pressure
variability. Additionally, we are pleased to announce the
presentation of our genotyping study analyzing the pharmacokinetics
of THC metabolization in diverse patient groups. IGC is committed
to increasing diversity in clinical trials and subsequently
developing effective treatments for all who are impacted by
Alzheimer’s disease. We are encouraged by the results of IGC-AD1 so
far and we continue to drive progress in our Phase 2 trial.”
To view the posters including data sets and conclusions visit
https://aaic.alz.org/
Poster Number: P2-694 Poster Title: Effect of the
Combination of Tetrahydrocannabinol and Melatonin (IGC-AD1) on
Blood Pressure Variability in Patients with Mild to Moderate
Alzheimer’s Disease Presenting Author: Maria Paula Naranjo,
David Silva-García, Evelyn Gutiérrez, Laura Tatiana Sánchez, Maria
Juanita Arbelaez, Maria Alejandra Tangarife, Laura Delgado-Murillo,
Diego Rodriguez-Soacha, Saadia Shahnawaz, Varduhi Ghazaryan, Maria
Paula Naranjo, Margarita Venegas, Karen Y. Pujals, William Julio,
Claudia Grimaldi, Krista Lanctôt, L. Elliot Hong, and Ram Mukunda
Session Title & Date: P2-01 Drug Development: Human
Monday July 17, 2023: 8:45 AM- 4.15 PM Poster Highlights:
Preliminary data from the Phase I multiple ascending dose study
suggests that investigational drug IGC-AD1 does not have a
significant impact on BP or BPV in AD patients with controlled and
uncontrolled BP. Regression analysis indicates that multiple
ascending doses between cohorts may have lowered average BP during
the trial.
Poster Number: P3-648 Poster Title: Cytochrome
P450 2C9 Polymorphism in Puerto Rican Alzheimer’s Disease Patients
and its Role in the Pharmacokinetics of IGC-AD1, an Investigational
Drug Presenting Author: Jagadeesh S Rao, Evelyn Gutierrez,
Claudia Grimaldi, William Julio, Saadia S Shahnawaz, and Ram
Mukunda Session Title & Date: P3-01 Drug Development:
Human Tuesday, July 18, 2023: 8:45 AM- 4.15 PM Poster
Highlights: Puerto Rican AD patients had 62% CYP2C9
polymorphism; 54% were intermediate metabolizers and 38% were
normal metabolizers. Intermediate metabolizers had altered THC
metabolism leading to longer THC half-lives compared with normal
metabolizers. Polymorphisms in CYP2C9 can lead to accumulation of
THC and its active metabolite as well as prolonging its
elimination.
Poster Number: P3-663 Poster Title: Reduction of
Neuropsychiatric Symptoms and Associated Caregiver Distress Using a
Combination of Tetrahydrocannabinol and Melatonin in Dementia due
to Alzheimer's Disease. Presenting Author: Alejandra
Tangarife, Evelyn Gutiérrez, Laura Tatiana Sanchez, Maria
Juanita Arbelaez, Laura Delgado-Murillo, Diego Rodriguez-Soacha,
Saadia Shahnawaz, Varduhi Ghazaryan, Maria Paula Naranjo, Margarita
Venegas, David Silva-García, Karen Y. Pujals, William Julio,
Claudia Grimaldi, Krista Lanctôt, L. Elliot Hong, Ram Mukunda
Session Title & Date: P3-01 Drug Development: Human
Tuesday, July 18, 2023: 8:45 AM – 4:15 PM Poster Highlights:
At all three dosages, IGC-AD1 led to a clinically and statistically
significant reduction in NPS and caregiver distress as measured by
the NPI-12. The active and placebo score comparison in this study
suggests that IGC-AD1 may be efficacious at reducing NPS in AD
patients.
Poster Number: P3-657 Poster Title: Effect of
Tetrahydrocannabinol and Melatonin Combination on Suicide Ideation
and Behavior in Dementia due to Alzheimer’s Disease Presenting
Author: Laura Delgado-Murillo, Evelyn Gutiérrez, Laura Tatiana
Sanchez, Maria Juanita Arbelaez, Maria Alejandra Tangarife, Diego
Rodriguez-Soacha, Saadia Shahnawaz, Varduhi Ghazaryan, Maria Paula
Naranjo, Margarita Venegas, David Silva-García, Karen Y. Pujals,
William Julio, Claudia Grimaldi, Krista Lanctôt, L. Elliot Hong,
and Ram Mukunda Session Title & Date: P3-01 Drug
Development: Human Tuesday, July 18, 2023: 8:45 AM – 4:15 PM
Poster Highlights: Clinically significant decreases in
NPI-12 (depression domain) were observed in all three study
cohorts. IGC-AD1 did not create a risk of developing suicidal
ideation or behavior as assessed by the C-SSRS in the mild to
moderate AD population during the 6-week Phase I trial. IGC-AD1
appears to be a promising pharmaceutical option for the treatment
of depression.
Poster Number: P3-660 Poster Title: Reduction of
Agitation and Caregiver Distress Using a Combination of
Tetrahydrocannabinol and Melatonin in Dementia due to Alzheimer's
Disease. Presenting Author: Maria Juanita Arbelaez,
Evelyn Gutiérrez, Laura Tatiana Sanchez, Maria Alejandra Tangarife,
Laura Delgado-Murillo, Diego Rodriguez-Soacha, Saadia Shahnawaz,
Varduhi Ghazaryan, Maria Paula Naranjo, Margarita Venegas, David
Silva-García, Karen Y. Pujals, William Julio, Claudia Grimaldi,
Krista Lanctôt, L. Elliot Hong, and Ram Mukunda Session Title
& Date: P3-01 Drug Development: Human Tuesday, July 18,
2023: 8:45 AM – 4:15 PM Poster Highlights: In the Phase 1
trial IGC-AD1 was found to be safe, well-tolerated, and caused no
serious Adverse Events. In the Active Group, the mean NPI Agitation
and NPI-D scores decreased by 36% and 55%, respectively. These NPI
Agitation and NPI-D scores indicate that IGC-AD1 may be efficacious
at reducing agitation due to AD and associated caregiver
distress.
Poster Number: P3-662 Poster Title: Reduction of
Apathy and Caregiver Distress Using a Combination of
Tetrahydrocannabinol and Melatonin in Dementia due to Alzheimer's
Disease. Presenting Author: Evelyn Gutiérrez, Laura
Tatiana Sanchez, Maria Juanita Arbelaez, Maria Alejandra Tangarife,
Laura Delgado-Murillo, Diego Rodriguez-Soacha, Saadia Shahnawaz,
Varduhi Ghazaryan, Maria Paula Naranjo, Margarita Venegas, David
Silva-García, Karen Y. Pujals, William Julio, Claudia Grimaldi, Ram
Mukunda, L. Elliot Hong, Krista Lanctôt Session Title &
Date: P3-01 Drug Development: Human Tuesday, July 18, 2023:
8:45 AM – 4:15 PM Poster Highlights: In Cohort 1, Cohort 2,
and Cohort 3, apathy as measured by NPI-Apathy decreased by 44.44%,
53.84%, and 49.88%, respectively. These results were clinically
significant.
About IGC Pharma, Inc.
IGC Pharma, Inc., (IGC) develops advanced cannabinoid-based
formulations for treating diseases and conditions, including, but
not limited to, Alzheimer’s disease, period cramps
(“dysmenorrhea”), premenstrual syndrome (“PMS”), and chronic pain.
IGC has two investigational drug assets targeting Alzheimer’s
disease, IGC-AD1 and TGR-63, which have demonstrated in Alzheimer’s
cell lines the potential to be effective in suppressing or
ameliorating key hallmarks of Alzheimer’s disease, such as plaques
or tangles. IGC-AD1 is a low-dose tetrahydrocannabinol (“THC”)
based formulation that is currently in an 146-person Phase 2
clinical trial for agitation in dementia due to Alzheimer’s
(clinicaltrials.gov, NCT05543681). IGC Pharma, Inc., also markets a
wellness brand, Holief™, that targets women experiencing
premenstrual syndrome and menstrual cramps.
Forward-looking
Statements
This press release contains forward-looking statements. These
forward-looking statements are based largely on IGC’s expectations
and are subject to several risks and uncertainties, certain of
which are beyond IGC’s control. Actual results could differ
materially from these forward-looking statements as a result of,
among other factors, the Company’s failure or inability to
commercialize one or more of the Company’s products or
technologies, including the products or formulations described in
this release, or failure to obtain regulatory approval for the
products or formulations, where required; general economic
conditions that are less favorable than expected, including as a
result of the ongoing COVID-19 pandemic; the FDA’s general position
regarding cannabis- and hemp-based products; and other factors,
many of which are discussed in IGC’s U.S. Securities and Exchange
Commission (“SEC”) filings. IGC incorporates by reference the human
trial disclosures and Risk Factors identified in its Annual Report
on Form 10-K filed with the SEC on July 7, 2023, as if fully
incorporated and restated herein. In light of these risks and
uncertainties, there can be no assurance that the forward-looking
information contained in this release will occur.
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version on businesswire.com: https://www.businesswire.com/news/home/20230718231297/en/
Investors Walter Frank igc@imsinvestorrelations.com (203)
972-9200
Media Rosalyn Christian
rchristian@imsinvestorrelations.com (203) 972-9200
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