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1 Trial |  |
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- || apilimod dimesylate (AIT-101) / OrphAI Therap
Trial completion, Trial completion date: Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Jun 23, 2025
P2, N=14, Completed, Sponsor: OrphAI Therapeutics
Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> May 2025
- || apilimod dimesylate (AIT-101) / OrphAI Therap
Clinical, P2a data, Journal: Apilimod dimesylate in C9orf72 amyotrophic lateral sclerosis: a randomized phase 2a clinical trial. (Pubmed Central) - Sep 3, 2024
P2
Apilimod dimesylate met prespecified key safety and biomarker endpoints in this Phase 2a trial and demonstrated CNS penetrance and pharmacodynamic target engagement. Apilimod dimesylate was observed to have the greatest reduction in CSF poly(GP) levels observed to date in C9orf72 clinical trials.
- | apilimod dimesylate (AIT-101) / OrphAI Therap
Phase classification, Trial completion date: Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Aug 20, 2024
P2, N=14, Active, not recruiting, Sponsor: OrphAI Therapeutics
Apilimod dimesylate was observed to have the greatest reduction in CSF poly(GP) levels observed to date in C9orf72 clinical trials. Phase classification: P2a --> P2 | Trial completion date: May 2024 --> Oct 2024
- apilimod dimesylate (AIT-101) / OrphAI Therap
AIT-101 Improves Functional Deficits in a Human TDP-43 Animal Model of ALS (Event Halle, Messe Basel, Ground Floor) - Nov 7, 2023 - Abstract #ALSMND2023ALS_MND_197;
There were also significant decreases in CSF (p < 0.00001) and plasma (p = 0.03) levels of neurofilament light (NfL). Quantitative IHC staining for hTDP43 and GFAP, a marker of neuroinflammation, showed significant decreases with AIT-101 in several areas of the cortex and corticospinal tract.
- apilimod dimesylate (AIT-101) / OrphAI Therap
Results of a double blind, placebo- controlled clinical trial of AIT-101 (LAM-002A) in C9orf72 ALS: A biomarker driven Phase 2A clinical trial targeting PIKfyve inhibition (Singapore, Level 2) - Nov 7, 2023 - Abstract #ALSMND2023ALS_MND_90;
- | apilimod dimesylate (AIT-101) / OrphAI Therap
Trial completion date: Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Sep 18, 2023
P2a, N=14, Active, not recruiting, Sponsor: AI Therapeutics, Inc.
Quantitative IHC staining for hTDP43 and GFAP, a marker of neuroinflammation, showed significant decreases with AIT-101 in several areas of the cortex and corticospinal tract. Trial completion date: Sep 2023 --> May 2024
- ||| apilimod dimesylate (AIT-101) / OrphAI Therap
Trial completion: A Study of LAM-002A for the Prevention of Progression of COVID-19 (clinicaltrials.gov) - Sep 16, 2022
P2, N=142, Completed, Sponsor: AI Therapeutics, Inc.
Trial completion date: Sep 2023 --> May 2024 Unknown status --> Completed
- | apilimod dimesylate (AIT-101) / OrphAI Therap
Enrollment closed, Trial completion date: Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Aug 12, 2022
P2a, N=14, Active, not recruiting, Sponsor: AI Therapeutics, Inc.
Unknown status --> Completed Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Sep 2023
- |||||| apilimod dimesylate (AIT-101) / OrphAI Therap
New trial: An Open-Label, Expanded Access Protocol of LAM-002A in C9ORF72-Associated Frontotemporal Dementia (FTD) (clinicaltrials.gov) - Aug 2, 2022
P=N/A, N=0, No Longer Available, Sponsor: AI Therapeutics, Inc.
- || apilimod dimesylate (AIT-101) / OrphAI Therap
Enrollment closed, Trial completion date: LAM-002A/NHL: A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - May 3, 2022
P1, N=62, Active, not recruiting, Sponsor: AI Therapeutics, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Sep 2023 Completed --> Active, not recruiting | Trial completion date: Aug 2020 --> Mar 2023
- || apilimod dimesylate (AIT-101) / OrphAI Therap
Enrollment open: Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Dec 27, 2021
P2a, N=12, Recruiting, Sponsor: AI Therapeutics, Inc.
Completed --> Active, not recruiting | Trial completion date: Aug 2020 --> Mar 2023 Not yet recruiting --> Recruiting
- ||| apilimod dimesylate (AIT-101) / OrphAI Therap
Trial completion: LAM-002A/NHL: A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Dec 20, 2021
P1, N=62, Completed, Sponsor: AI Therapeutics, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || apilimod dimesylate (AIT-101) / OrphAI Therap
New P2a trial: Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Dec 20, 2021
P2a, N=12, Not yet recruiting, Sponsor: AI Therapeutics, Inc.
- | apilimod (STA-5326) / Madrigal Pharma
Journal: The PIKfyve Inhibitor Apilimod: A Double-Edged Sword against COVID-19. (Pubmed Central) - Jan 23, 2021
However, although apilimod might prevent viral invasion by inhibiting host cell proteases, the same proteases are critical for antigen presentation leading to T cell activation and there is good evidence from both in vitro studies and the clinic that apilimod blocks antiviral immune responses. We therefore warn that the immunosuppression observed in many COVID-19 patients might be aggravated by apilimod.
- || apilimod dimesylate (AIT-101) / OrphAI Therap
Trial primary completion date: A Study of LAM-002A for the Prevention of Progression of COVID-19 (clinicaltrials.gov) - Nov 3, 2020
P2, N=142, Recruiting, Sponsor: AI Therapeutics, Inc.
We therefore warn that the immunosuppression observed in many COVID-19 patients might be aggravated by apilimod. Trial primary completion date: Dec 2020 --> Mar 2021
- ||| apilimod dimesylate (AIT-101) / OrphAI Therap
Enrollment open: A Study of LAM-002A for the Prevention of Progression of COVID-19 (clinicaltrials.gov) - Jul 16, 2020
P2, N=142, Recruiting, Sponsor: AI Therapeutics, Inc.
Trial primary completion date: Dec 2020 --> Mar 2021 Not yet recruiting --> Recruiting
- |||| apilimod dimesylate (AIT-101) / OrphAI Therap
New P2 trial: A Study of LAM-002A for the Prevention of Progression of COVID-19 (clinicaltrials.gov) - Jun 23, 2020
P2, N=142, Not yet recruiting, Sponsor: AI Therapeutics, Inc.
- [VIRTUAL] Results of a completed phase I study of LAM-002 (apilimod dimesylate), a first-in-class phosphatidylinositol-3-phosphate 5 kinase (PIKfyve) inhibitor, administered as monotherapy or with rituximab or atezolizumab to patients with previously treated follicular lymphoma or other B-cell cancers. (Poster Board 350) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2135;
P1
LAM-002 does not cause the myelosuppressive or immune adverse events associated with lenalidomide or PI3K inhibitors. Promising efficacy supports registration-directed Phase 2/3 testing of LAM-002 monotherapy and combination therapy for patients with previously treated follicular lymphoma.
- | apilimod dimesylate (AIT-101) / OrphAI Therap
Enrollment closed: LAM-002A/NHL: A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Aug 14, 2019
P1, N=62, Active, not recruiting, Sponsor: AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)
Promising efficacy supports registration-directed Phase 2/3 testing of LAM-002 monotherapy and combination therapy for patients with previously treated follicular lymphoma. Recruiting --> Active, not recruiting
- | apilimod dimesylate (AIT-101) / OrphAI Therap
Trial completion date, Trial primary completion date: LAM-002A/NHL: A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Jul 5, 2019
P1, N=75, Recruiting, Sponsor: AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)
Recruiting --> Active, not recruiting Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: May 2019 --> May 2020
- apilimod dimesylate (AIT-101) / OrphAI Therap
New P1 trial: LAM-002A/NHL: A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Nov 3, 2015
P1, N=75, Recruiting, Sponsor: Lam Therapeutics Inc.