cromolyn sodium/ibuprofen (ALZT-OP1) / AZTherapies - LARVOL DELTA

Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China. (PubMed, Front Neurol) - "The research and development pipeline now focuses on disease-modifying therapies such as gantenerumab, aducanumab, ALZ-801, ALZT-OP1, donanemab, lecanemab, simufilam, NE3107, semaglutide, and GV-971, which could put an end to the situation where Alzheimer's patients in China have no effective treatment alternatives. The reuse of drugs or combinations currently under investigation for the psychiatric treatment of Alzheimer's disease, including AXS-05, AVP-786, nabilone, brexpiprazole, methylphenidate, and pimavanserin, could provide physicians with additional treatment options. Although most of these drugs have not been explored in China yet, due to the current development trend in this field in China, it is expected that China will be involved in research on these drugs in the future."

Journal • Review • Alzheimer's Disease • CNS Disorders • Psychiatry

ALZT-OP1: An experimental combination regimen for the treatment of Alzheimer's Disease. (PubMed, Expert Opin Investig Drugs) - "For Alzheimer's disease (AD) treatment, US FDA granted accelerated approval for aducanumab due to its amyloid-β (Aβ)-lowering effects, notwithstanding the reported poor correlation between amyloid plaque reduction and clinical change for this drug...Long-term follow-up indicated that non-steroidal anti-inflammatory drugs use begun when the brain was still normal may benefit these patients, suggesting that the timing of therapy could be crucial. However, previous clinical failures and the present incomplete understanding of the Aβ pathophysiological role in AD put this novel experimental combination regimen at substantial risk of failure."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders • Immunology • Inflammation

Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers (clinicaltrials.gov) - P1/2; N=56; Completed; Sponsor: AZTherapies, Inc.; Recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Alzheimer's Disease • CNS Disorders • CD33 • GFAP • IFNG • TGFB1 • TNFA

COGNITE: Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (clinicaltrials.gov) - P3; N=620; Completed; Sponsor: AZTherapies, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Alzheimer's Disease • CNS Disorders

AZTherapies Completes COGNITE Phase 3 Alzheimer’s Clinical Trial; Top-Line Data Readout Expected in First Quarter of 2021 (GlobeNewswire) - "AZTherapies, Inc....today announced the completion of the last patient/last visit in its COGNITE Phase 3 clinical trial, which is evaluating the safety and efficacy of ALZT-OP1, an investigational combination treatment for patients with early stage Alzheimer’s disease....'We expect to announce the COGNITE top-line clinical results in the first quarter of 2021.'"

P3 data: top line • Trial completion • Alzheimer's Disease • CNS Disorders

AZTherapies Announces Closing of $33.6 Million Series C-1 Financing Building Upon Recent $37.5 Million Series C Financing (GlobeNewswire) - "AZTherapies, Inc....today announced the closing of a $33.6 million Series C-1 Preferred Stock financing. This C-1 round follows the receipt earlier this year of an additional $11.2 million from the company’s previously announced Series C Preferred Stock financing, which raised aggregate gross proceeds of $37.5 million....'This additional funding positions us extremely well as we drive towards completion of our Phase 3 COGNITE trial in Alzheimer’s disease later this year, with data readout expected in early 2021...'"

Financing • P3 data • Alzheimer's Disease • CNS Disorders

Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: AZTherapies, Inc.

Clinical • Combination therapy • New P1/2 trial • Alzheimer's Disease • CNS Disorders • CD33 • GFAP

Anti-Amyloid-β Protein agents for the treatment of Alzheimer's Disease: An update on emerging drugs. (PubMed, Expert Opin Emerg Drugs) - "At present, anti-Aβ compounds in Phase III clinical development for AD include four monoclonal antibodies (solanezumab, gantenerumab, aducanumab, BAN2401), the combination of cromolyn sodium and ibuprofen (ALZT-OP1), and two small molecules (levetiracetam, GV-971). The actual results support the hypothesis that elevated Aβ represents an early stage in the AD continuum and demonstrate the feasibility of enrolling these high-risk participants in secondary prevention trials to slow cognitive decline during the AD preclinical stages. However, a series of clinical failures may question further development of Aβ-targeting drugs and the findings from current ongoing Phase III trials will hopefully give light to this critical issue."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders

One new drug may treat both Covid-19 and Alzheimer’s (Israel21c) - "The investigational therapy, ALZT-OP1, suppresses the immune system’s production of cytokines....AZTherapies identified participants based on cognition, function tests and brain pathology assessed by Alzheimer’s biomarkers in spinal fluid. 'We screened 1,753 people in North America and Europe, and from that we got 620 subjects with the biomarkers that indicate early Alzheimer’s, ' Elmaleh says. Of those 620, 589 completed 24 weeks of treatment, 492 completed 48 weeks of treatment, and 380 completed the whole 72-week study cycle....AZTherapies prepared a clinical trial protocol for the FDA and has approached several European countries and Israeli hospitals about trying its drug candidate on Covid-19 patients."

Cytokine storm • New trial • Alzheimer's Disease • CNS Disorders • Infectious Disease • Novel Coronavirus Disease

COGNITE: Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: AZTherapies, Inc.; Trial primary completion date: Mar 2018 ➔ Nov 2019

Trial primary completion date • Alzheimer's Disease • Biosimilar • CNS Disorders

AZTherapies closes $26.3 million Series C Preferred equity financing (GlobeNewswire) - “Proceeds to support ongoing Phase 3 Alzheimer’s clinical trial, expected to complete in 2020, and advancement of pipeline of candidates targeting neuroinflammation...AZTherapies…announced the closing of a $26.3 million Series C Preferred equity financing….’This round will provide crucial support as we work to complete the COGNITE trial by the end of next year and advance our next candidate, AZT-101, into a Phase 2 clinical trial in patients with post-ischemic stroke cognitive impairment and into a Phase 1/2a clinical trial in amyotrophic lateral sclerosis (ALS).’”

Financing

LANDSCAPE ASSESSMENT AND KEY HTA CONSIDERATIONS IN ALZHEIMER'S DISEASE (ISPOR-EU 2019) - "Twenty-six DMT were evaluated in early/mild AD (26 agents) with 10 agents progressed to late stage phase II/III trials expecting launch by 2025 and 5 agents (TRx0237, E2609, ALZT-OP1, Crenezumab, and Gantenerumab) expecting launch by 2021. Possible advent of DMTs based on trials using validated outcomes for assessment is indicative. However, there is need to fill evidence gaps related to long-term impact on patients and caregivers."

AZTherapies Completes Enrollment in COGNITE Pivotal Phase 3 Trial of ALZT-OP1 for the Treatment of Early Alzheimer’s Disease (GlobeNewswire, AZTherapies, Inc.) - "AZTherapies, Inc, a biopharmaceutical company developing therapeutics to extend brain health, today announced that it has completed target enrollment in its COGNITE Phase 3 clinical trial, evaluating the safety and efficacy of ALZT-OP1 for the treatment of early Alzheimer’s disease....'I am encouraged by the continued progress in this clinical trial,' said Martin Farlow, MD...With the COGNITE trial now fully enrolled, we are one step closer to providing Alzheimer’s patients with new hope for a treatment and look forward to completing the trial in late 2020.”"

Biomarker • Clinical • Enrollment status • Regulatory

COGNITE: Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (clinicaltrials.gov) - P3; N=620; Active, not recruiting; Sponsor: AZTherapies, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Jun 2019 ➔ Dec 2020

Clinical • Enrollment closed • Trial primary completion date

AZTherapies to Present at Maxim Group’s Conference on Alzheimer’s Disease (GlobeNewswire, AZTherapies, Inc.) - "AZTherapies...today announced that it will be presenting at the Maxim Group’s conference on Alzheimer’s disease. The meeting, entitled “Alzheimer’s Disease – What’s Next? Treating Alzheimer’s in a Post-Amyloid World,” is taking place in New York City from noon to 5 pm today.During today’s presentation, AZTherapies will discuss its differentiated approach to treating Alzheimer’s disease, which employs a multi-modal mechanism that includes targeting the neuroinflammation that leads to neuronal death by shifting the brain’s microglial immune cells to their neuroprotective state. The Company’s lead candidate, ALZT-OP1, is currently being evaluated in a Phase 3 clinical trial in patients with early."

Clinical • P3 data

COGNITE: Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: AZTherapies, Inc.; Trial completion date: Nov 2019 ➔ Dec 2020; Trial primary completion date: Nov 2019 ➔ Jun 2019

Clinical • Trial completion date • Trial primary completion date