Two very different biotechs—one focused on pushing through an early Alzheimer’s disease drug and the other a phase 3 heart rate condition company—are looking for the very same IPO price.
That life sciences IPO window just won’t close, and more biotechs are jumping through. First up is California-based Alzheimer's biotech Cortexyme, which has filed for an $86 million IPO.
Cortexyme, backed by the likes of Pfizer, Verily and Takeda, last year got off a $76 million funding round for a potentially first-in-class treatment, COR388, which targets a bacterial infection in the brain the company believes causes the degenerative symptoms of the disease.
This is a different approach compared to the plaques and tangles theory dominating the Alzheimer's field, a field buried with dead projects that have continually failed to meet the grade.
Cortexyme’s COR388 targets a pathogen discovered in the brains of Alzheimer’s patients by the startup’s co-founder and chief scientific officer, Stephen Dominy, M.D., and employs a different mechanism of action than broad-spectrum antibiotics.
In the company’s recent phase 1 safety study launched last in January, COR388 was well-tolerated by healthy volunteers aged 20 to 70 in single-ascending and multiple-ascending doses compared to placebo. The company said at the time that it noted “favorable pharmacokinetics and tissue distribution when given orally.”
COR388 is designed to target “upstream drivers” in Alzheimer’s, such as amyloid beta production, as well as other Alzheimer’s pathological pathways, including inflammation and neurodegeneration.
This, it says, is in contrast to mechanisms of actions targeting downstream effects, such as amyloid plaques and tau tangles, which haven’t worked.
In its SEC-1 filing the biotech, which was founded back in 2012, says given its MOA: “We believe COR388 could represent a disease-modifying therapy for the chronic treatment of Alzheimer’s disease.”
The drug has also been through a phase 1b clinical, which showed “improvements across several exploratory cognitive tests” commonly used with Alzheimer’s patients and in Alzheimer’s trials, such as Mean Mini-Mental State Exam, Cambridge Neuropsychological Test Automated Battery composite and Winterlight speech-based cognitive assessment.
However, in its filing, the biotech admitted not all of these improvements were statistically significant. It did see that COR388 successfully penetrated the blood-brain barrier.
The plan now, which it hopes the IPO will boost, is to get 570 mild to moderate Alzheimer’s patients in its phase 2/3 GAIN trial. This will look at safety and how well the drug works after one year of treatment as measured on key endpoints, including the Alzheimer’s disease Assessment Scale-Cognitive Subscale 11, or ADAS-Cog11. It will hope to be hitting statistical significance here.
But, while talking up how it’s different, Cortexyme must still battle against the inherent risk of trying to get an Alzeimer's drug to market: Just ask Axovant, which failed miserably in its attempt to re-hash an old drug into working against the memory-wasting disease and had to pivot to become a gene therapy company. Or see Alzheon, another biotech that has repeatedly pulled its IPO attempts.
And then there is Milestone Pharmaceuticals, a 16-year old Canadian biotech focused on a phase 3 for the heart rate condition paroxysmal supraventricular tachycardia, or PSVT, in which the heart can beat over 200 times per minute. Last fall, Milestone brought in $80 million to fund the at-home, phase 3 test of its nasal spray for quickly bringing down super-high heart rates. It now wants the same $86 million IPO as Cortexyme for its lead program, etripamil, a short-acting calcium channel blocker for PSVT.
While not life-threatening on its own, this condition can cause great distress and anxiety in patients, and lead to trips to the emergency room and the use of intravenous drugs to calm the heart, such as adenosine or verapamil, a channel blocker with the same mechanism of action as etripamil.
The biotech also hopes to conduct signal-finding studies in additional indications for the etripamil spray, such as atrial fibrillation or stable angina. With an effective half-life of about 25 minutes, the company sees etripamil as a safer alternative to IV drugs, and one that can be taken anywhere. Two phase 3 tests are ongoing.
It remains to be seen how this at-home drug could be paired with at-home devices, such as the latest version of the Apple Watch with a built-in ECG, or other wearable devices from companies such as AliveCor and Fitbit.
“We're hitting late-stage development, and hopefully commercialization, at the time right when these wearables are going to put ECGs on our wrists,” its CEO Joseph Oliveto told FierceBiotech last year.
That newly available data could be used to help physicians better diagnose the condition, where heart rates can return to normal before a patient can get to an ER or doctor’s office.
The Montreal-based company was founded back in 2003 and plans to list on the Nasdaq under the ticker "MIST."