IGC Pharma's Phase 2 Clinical Trial Interim Data Demonstrates Significant Reduction in Sleep Disturbances
IGC Pharma (NYSE American:IGC) has reported positive interim results from its Phase 2 clinical trial of IGC-AD1, targeting agitation in Alzheimer's patients. The trial demonstrated significant reductions in sleep disturbances: 71% reduction at week 2 (p=.012) and 78% reduction at week 6 (p=.02) compared to placebo, measured via NPI-12 Sleep Subscale.
IGC-AD1, a cannabinoid-based partial CB1 receptor agonist, shows promise in addressing sleep disorders affecting up to 44% of Alzheimer's patients. The treatment's mechanism differs from traditional sedatives, potentially offering a safer alternative to current options like Trazodone and Suvorexant, which have shown effectiveness in dementia patients.
The ongoing CALMA trial's complete analysis is expected by end-2025. The company plans to evaluate IGC-AD1 as an Alzheimer's disease-modifying drug, targeting a global sleep aid market projected to exceed $100 billion by 2030.
IGC Pharma (NYSE American:IGC) ha riportato risultati intermedi positivi dal suo trial clinico di Fase 2 su IGC-AD1, mirato a ridurre l'agitazione nei pazienti affetti da Alzheimer. Lo studio ha dimostrato riduzioni significative delle perturbazioni del sonno: riduzione del 71% alla settimana 2 (p=.012) e riduzione del 78% alla settimana 6 (p=.02) rispetto al placebo, misurato tramite la sottoscala del sonno NPI-12.
IGC-AD1, un agonista parziale del recettore CB1 a base di cannabinoidi, mostra potenzialità nel trattare i disturbi del sonno che colpiscono fino al 44% dei pazienti affetti da Alzheimer. Il meccanismo d'azione del trattamento è diverso da quello dei sedativi tradizionali, offrendo potenzialmente un'alternativa più sicura rispetto alle attuali opzioni come Trazodone e Suvorexant, che hanno dimostrato efficacia nei pazienti con demenza.
L'analisi completa del trial CALMA è prevista per la fine del 2025. L'azienda prevede di valutare IGC-AD1 come un farmaco modificante la malattia di Alzheimer, mirando a un mercato globale degli aiuti per il sonno che si prevede supererà i 100 miliardi di dollari entro il 2030.
IGC Pharma (NYSE American:IGC) ha reportado resultados interinos positivos de su ensayo clínico de Fase 2 de IGC-AD1, dirigido a la agitación en pacientes con Alzheimer. El ensayo demostró reducciones significativas en las perturbaciones del sueño: reducción del 71% en la semana 2 (p=.012) y reducción del 78% en la semana 6 (p=.02) en comparación con el placebo, medido a través de la subescala de sueño NPI-12.
IGC-AD1, un agonista parcial del receptor CB1 basado en cannabinoides, muestra promesas en el tratamiento de los trastornos del sueño que afectan hasta al 44% de los pacientes con Alzheimer. El mecanismo del tratamiento es diferente al de los sedantes tradicionales, lo que podría ofrecer una alternativa más segura a las opciones actuales como Trazodona y Suvorexant, que han demostrado eficacia en pacientes con demencia.
Se espera que el análisis completo del ensayo CALMA esté disponible para finales de 2025. La empresa planea evaluar IGC-AD1 como un fármaco modificador de la enfermedad de Alzheimer, apuntando a un mercado global de ayudas para el sueño que se proyecta superará los 100 mil millones de dólares para 2030.
IGC Pharma (NYSE American:IGC)는 알츠하이머 환자의 불안감을 목표로 하는 IGC-AD1의 2상 임상 시험에서 긍정적인 중간 결과를 보고했습니다. 이 시험은 수면 장애에서 유의미한 감소를 보여주었습니다: 2주차 71% 감소 (p=.012) 및 6주차 78% 감소 (p=.02)로, 위약과 비교하여 NPI-12 수면 하위 척도를 통해 측정되었습니다.
IGC-AD1은 부분 CB1 수용체 작용제로서, 알츠하이머 환자의 44%까지 영향을 미치는 수면 장애를 해결하는 데 가능성을 보여줍니다. 이 치료법의 메커니즘은 전통적인 진정제와 다르며, 현재의 옵션인 트라조돈과 수보렉산트보다 더 안전한 대안을 제공할 수 있습니다. 이 두 약물은 치매 환자에게 효과를 보였습니다.
진행 중인 CALMA 시험의 완전한 분석은 2025년 말까지 예상됩니다. 이 회사는 IGC-AD1을 알츠하이머 질병 수정 약물로 평가할 계획이며, 2030년까지 1천억 달러를 초과할 것으로 예상되는 글로벌 수면 보조제 시장을 목표로 하고 있습니다.
IGC Pharma (NYSE American:IGC) a rapporté des résultats intermédiaires positifs de son essai clinique de phase 2 sur IGC-AD1, visant à réduire l'agitation chez les patients atteints d'Alzheimer. L'essai a démontré des réductions significatives des troubles du sommeil : réduction de 71 % à la semaine 2 (p=.012) et réduction de 78 % à la semaine 6 (p=.02) par rapport au placebo, mesurée via la sous-échelle de sommeil NPI-12.
IGC-AD1, un agoniste partiel du récepteur CB1 à base de cannabinoïdes, montre des promesses pour traiter les troubles du sommeil touchant jusqu'à 44 % des patients atteints d'Alzheimer. Le mécanisme d'action du traitement diffère de celui des sédatifs traditionnels, offrant potentiellement une alternative plus sûre aux options actuelles comme la Trazodone et le Suvorexant, qui ont montré leur efficacité chez les patients atteints de démence.
L'analyse complète de l'essai CALMA est attendue d'ici fin 2025. L'entreprise prévoit d'évaluer IGC-AD1 comme un médicament modifiant la maladie d'Alzheimer, ciblant un marché mondial des aides au sommeil qui devrait dépasser 100 milliards de dollars d'ici 2030.
IGC Pharma (NYSE American:IGC) hat positive Zwischenresultate aus seiner Phase-2-Studie zu IGC-AD1 veröffentlicht, die auf die Unruhe bei Alzheimer-Patienten abzielt. Die Studie zeigte signifikante Reduktionen bei Schlafstörungen: 71% Reduktion in Woche 2 (p=.012) und 78% Reduktion in Woche 6 (p=.02) im Vergleich zur Placebo-Gruppe, gemessen über die NPI-12 Schlafunterskala.
IGC-AD1, ein cannabinoidbasierter partieller CB1-Rezeptoragonist, zeigt vielversprechende Ansätze zur Behandlung von Schlafstörungen, die bis zu 44% der Alzheimer-Patienten betreffen. Der Wirkmechanismus der Behandlung unterscheidet sich von traditionellen Sedativa und könnte eine sicherere Alternative zu aktuellen Optionen wie Trazodon und Suvorexant bieten, die bei Demenzpatienten wirksam sind.
Die vollständige Analyse der laufenden CALMA-Studie wird bis Ende 2025 erwartet. Das Unternehmen plant, IGC-AD1 als ein krankheitsmodifizierendes Medikament bei Alzheimer zu bewerten, mit dem Ziel, einen globalen Schlafhilfenmarkt anzusprechen, der bis 2030 voraussichtlich über 100 Milliarden Dollar überschreiten wird.
- Significant sleep disturbance reduction: 71% at week 2 and 78% at week 6 with statistical significance
- Potential dual benefit: addresses both sleep disorders and agitation in Alzheimer's patients
- Large market opportunity: targeting $100B+ global sleep aid market by 2030
- Competitive advantage: shows better initial results compared to existing treatments (Trazodone and Suvorexant)
- Larger trials still needed to confirm efficacy and safety
- Complete trial results not available until end-2025
- Current results are interim and based on data
Insights
IGC Pharma's interim Phase 2 data for IGC-AD1 represents a significant positive development in their clinical program. The reported
The dual mechanism addressing both sleep disturbances and previously reported agitation reduction positions IGC-AD1 as a potential multi-symptom therapy for Alzheimer's, targeting an underserved population where up to
As a cannabinoid-based partial CB1 receptor agonist with anti-neuroinflammatory properties, IGC-AD1's mechanism differs from traditional sedatives. This pharmacological profile could potentially address root causes rather than merely masking symptoms.
For a micro-cap company (
These interim results demonstrate compelling efficacy signals for IGC-AD1 in addressing sleep disturbances in Alzheimer's patients. The
Particularly noteworthy is the connection between improved sleep quality and reduced amyloid accumulation. Sleep disturbances disrupt the glymphatic system's ability to clear neurotoxic waste products, including amyloid-beta. By potentially improving sleep architecture, IGC-AD1 might offer both symptomatic relief and disease-modifying potential.
The dual benefit of addressing both agitation and sleep disruption is clinically valuable, as these symptoms often co-occur and exacerbate each other. Current treatment options like benzodiazepines carry significant risks of falls, cognitive worsening, and dependency in elderly patients.
While these findings are promising, several questions remain: dose-response relationships, durability beyond 6 weeks, safety profile in this vulnerable population, and whether the effects translate to objective sleep measures beyond the NPI-12 subscale. The upcoming disease-modifying studies will be particularly important to determine if the sleep improvements correlate with changes in biomarkers or disease progression.
- IGC-AD1 Could Offer Safer Alternative to Existing Sleep Medications for Alzheimer's -
POTOMAC, MD / ACCESS Newswire / March 26, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced additional positive interim results from its ongoing Phase 2 clinical trial on IGC-AD1, an investigational treatment for agitation in dementia due to Alzheimer's disease.
Based on the interim analysis at week 2 sleep disturbance was reduced by about
The results suggest that IGC-AD1 may decrease the frequency and/or severity of sleep disturbances and nighttime behaviors, addressing a critical yet underrecognized challenge in Alzheimer's care that impacts up to
"IGC-AD1's ability to improve sleep quality in Alzheimer's patients is very exciting," said Ram Mukunda, CEO of IGC Pharma. "Better sleep is linked to reduced agitation and caregiver distress, as well as slowing cognitive decline and improving overall quality of life."
Improved sleep quality has been linked to reduced amyloid accumulation and slower disease progression. Additionally, previously reported data from the trial demonstrated notable reductions in agitation, reinforcing IGC-AD1's potential as a multi-targeted therapy for addressing neuropsychiatric symptoms in Alzheimer's patients.
Current treatment options including Trazodone and Suvorexant have shown limited improvement in placebo-controlled trials with dementia patients. IGC-AD1's differentiated mechanism offers the potential, if confirmed by larger trials, for a safer, more effective alternative for Alzheimer's patients.
Beyond Alzheimer's over 30 million Americans suffer from sleep disorders, which is a risk factor for cognitive decline and cardiovascular disease. The global sleep aid market is projected to surpass
IGC-AD1 is a cannabinoid-based partial CB1 receptor agonist with anti-neuroinflammatory and neuroprotective properties. Unlike sedatives, which primarily mask symptoms, IGC-AD1 may, if confirmed by larger trials, provide a safer, more effective approach to target sleep regulation in Alzheimer's disease.
IGC Pharma is progressing its Phase 2 trial of IGC-AD1, recently named CALMA, with further analysis expected in the end-2025, including on sleep disturbance. The Company also expects to launch studies to evaluate IGC-AD1 as an Alzheimer's disease modifying drug.
For more information about the ongoing clinical trial, visit clinicaltrials.gov.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 55 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies. Additionally, the Company operates Holiby™, a wellness brand offering scientifically formulated products for immunity, energy, and longevity.
Forward-Looking Statements:
This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma'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, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Qs filed with the SEC on August 7, 2024, November 12, 2024, and February 14, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.
Contact Information:
Rosalyn Christian
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire
FAQ
What are the interim results of IGC's Phase 2 trial for IGC-AD1 in sleep improvement?
How does IGC-AD1 differ from traditional sleep medications for Alzheimer's patients?
When will IGC Pharma complete the Phase 2 CALMA trial analysis?
What is the market potential for IGC-AD1 in the sleep aid industry?
What percentage of Alzheimer's patients could benefit from IGC-AD1's sleep improvement effects?
