Candidate: LAM-002 (apilimod)
Type: Selective first-in-class, oral PIKfyve kinase inhibitor being developed in B-cell non-Hodgkin lymphoma and amyotrophic lateral sclerosis/frontotemporal dementia
Status: AI Therapeutics co-founder Jonathan Rothberg, PhD, told GEN the company is preparing INDs for submission to the FDA, with the goal of launching clinical trials of LAM-002 in COVID-19 in the second quarter. He citing new data that he said showed the drug was effective in cell assays in inhibiting the entry of SARS-CoV-2 through its first-in-class molecular mechanism. SAM-002 can also be combined with other antiviral drugs, which typically target other molecular mechanisms, like viral replication. AI is looking to combine SAM-002 with Gilead Sciences’ Remdesivir, said Rothberg, recipient of the 2013 National Medal of Technology and Innovation in Engineering for pioneering inventions and commercialization of next generation DNA sequencing technologies.
AI is collaborating with Yale University Medical School (clinical studies), and Zhejiang University (nonclinical). AI Therapeutics and collaborators have shown that in cell cultures, LAM-002 was effective alone and lowered the level of SARS-CoV-2 virus even more when combined with Gilead Sciences’ Remdesivir. “We have 50,000 pills ready to go, we have a drug that has been shown to be safe in 800 patients, and we just made a commitment for 110,000 more pills and material for 5 Million more,” Rothberg added.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: