In April, Alzheon attempted an initial public offering (IPO) to raise $80 million, but withdrew the offering. It has decided to try again, filing with the U.S. Securities and Exchange Commission (SEC), indicating it planned to raise $40 million in an IPO.
In April, Alzheon attempted an initial public offering (IPO) to raise $80 million, but withdrew the offering. It has decided to try again, filing with the U.S. Securities and Exchange Commission (SEC), indicating it planned to raise $40 million in an IPO.
The company is working in the high-risk category of Alzheimer’s disease. Its lead product candidate is ALZ-801, an orally-administered inhibitor of beta-amyloid misfolding. Beta-amyloid is believed to be the primary cause of memory loss and cognition problems associated with Alzheimer’s disease, and most drug candidates for the disease focus on preventing or clearing beta-amyloid. However, numerous failures have cast doubt on the amyloid theory.
In the prospectus, Alzheon notes, “We believe that we are the only company developing a clinical stage small molecule with a mechanism of action designed to prevent the misfolding and aggregation of beta amyloid protein into neurotoxic oligomers. If ALZ-801 is approved, we believe it has the potential to be among the first drugs to intervene in a key underlying mechanism of Alzheimer’s disease, or AD. The active ingredient of ALZ-801, tramiprosate, was evaluated in 16 clinical trials conducted by BELLUS Health (formerly Neurochem), or Bellus, including trials in AD, with over 2,000 patients. In these trials, a favorable safety profile was observed, and in our post hoc analyses of data from these trials, we observed promising clinical signals in a subset of patients with two copies of the APOE4 gene, or APOE4/4 homozygotes, who have greater beta amyloid burden and develop AD earlier.”
The company hopes to use the funds raised to launch a Phase IIb clinical trial of ALZ-801 in the first half of 2019 in the U.S., and possibly internationally. It also expects to start a Phase Ib clinical trial to evaluate the plasma pharmacokinetics (PK) of ALZ-801 in AD patients with one or two copies of the APOE4 gene later this year.
The April IPO bookrunners were Citi and Piper Jaffray. For this attempt, it is ThinkEquity. It expects to list on the Nasdaq under the symbol ALZH.
On July 23, Alzheon announced it was presenting data at the Alzheimer’s Association International Conference (AAIC) on July 25 describing new research on tramiprosate, the active ingredient in ALZ-801. One presentation indicated that more patients remained cognitively stable over 78 weeks on the drug based on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale, reporting 57 percent on the drug and 20 percent for placebo. The second presentation indicated that more patients had minimal or no decline in function over 78 weeks of treatment based on the Disability Assessment for Dementia (DAD), with 46 percent on the drug and 18 percent on placebo.
“Responder rates in APOE4/4 patients with Mild AD support meaningful efficacy of tramiprosate in this population, and will help us design our planned confirmatory studies with ALZ-801,” said Susan Abushakra, Alzheon’s chief medical officer, in a statement at the time. “We continue to build on the body of clinical evidence to support the development of ALK-801, and we are enthusiastic to initiate the pivotal program with ALZ-801 for Alzheimer’s patients in need of effective treatment.”
