Clinical-stage biopharmaceutical firm Synaptogenix (NASDAQ:SNPX) demonstrated the harsh pitfalls associated with innovative medicine. Following the disclosure of disappointing results for its Phase 2 study involving the treatment of advanced Alzheimer’s disease, SNPX stock dropped 70% on Friday morning, extending losses to around 74% in the late afternoon. While upstart biotechs often represent speculative ventures, Synaptogenix’s horrendous hemorrhaging centers on the apparent failure of a key medical thesis.
Specifically, the company released topline data from its Phase 2 clinical trial of bryostatin-1, a powerful protein kinase C (PKC) agonist, which targets tumor growth prevention. However, preclinical studies demonstrated that bryostatin-1 at appropriate doses facilitates “cognitive restorative and antidepressant effects,” per a research paper published by the National Library of Medicine.
On paper, the cognitive restorative component augured well for SNPX stock. However, the Phase 2 study’s “primary endpoint of change from baseline in the Severe Impairment Battery (SIB) total score assessment obtained after completion of the second course of treatment (week 28) was not met with statistical significance,” per Synaptogenix’s disclosure.
“We are disappointed in the topline results from this Phase 2 trial,” stated in part Synaptogenix CEO Alan Tuchman, M.D. “Having just received the primary endpoint data, we are conducting a full review of all of the trial data to determine potential next steps and will provide an update of our plans when appropriate.”
SNPX Stock Epitomizes Longstanding Failures of Alzheimer’s Treatments
Arguably, most investors participating in clinical-stage biotechs like SNPX stock understand the feast-or-famine nature of the underlying sector. While Synaptogenix features a strong balance sheet — particularly characterized by a zero-debt profile — it generates no revenue. Therefore, shares depend on the whims of clinical results.
However, the unusually sharp loss for SNPX stock centers not just on sector volatility but also on the specific medical indication. As the Washington Post noted in April 2020, Alzheimer’s research represents a “long and frustrating struggle to find a drug.” The article goes on to cite several high-profile biopharmaceutical firms incurring failure after failure.
“More than 200 promising leads have fallen through just in the past decade. There has been an ongoing search for Alzheimer’s drugs since the 1990s, but ‘the long and short of it is that it’s not been successful,’ says Lon Schneider, an Alzheimer’s researcher at the University of Southern California’s Keck School of Medicine.”
Still, it’s not just the graveyard of would-be treatments turned snake oil that devastated SNPX stock. Like so many other treatments for this dreaded disease, bryostatin-1 aimed for cognitive restoration through the “reduction of neurotoxic amyloid accumulation and tau protein hyperphosphorylation,” per the aforementioned research published by the National Library of Medicine.
Unfortunately, as WaPo mentioned, with so many treatments targeting amyloid reduction, their combined failures to meet the primary endpoint of cognitive improvement represents a repudiation of the “amyloid hypothesis.” Therefore, Synaptogenix’s clinical miss offers yet more reason to be skeptical of similar treatments.
For the biotech industry, it implies a return to the drawing board. For SNPX stock, investor patience may have run out.
On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
