vTv Therapeutics Collapses as Alzheimer’s Disease Drug Missed Primary Endpoint
It’s a short and dramatic plunge for vTv Therapeutics Inc (NASDAQ:VTVT). Today, the drug maker’s shares lost over 70% of their value after the company announced that azeliragon, a RAGE inhibitor in development for Alzheimer’s disease (AD), failed in Part A of the STEADFAST Phase 3 trial. As the product failed to separate from placebo, VTVT plans to stop current clinical studies on azeliragon, while it continues to analyze subset data from Parts A and B.
vTv CEO Steve Holcombe commented, “We will continue to analyze the datasets and trends within subgroups from both Part A and Part B to determine if there are potential benefits or future uses and applications for azeliragon […] On behalf of vTv Therapeutics, we’d like to extend our most sincere and heartfelt gratitude to study participants, their families, physicians and caregivers for their commitment to this important study.”
Canaccord analyst Sumant Kulkarni opined, “Given the high rate of failure of candidates in development for AD and because no drug has been shown to slow progression of the disease as yet, this outcome is not a surprise to us. Essentially, we viewed this single-digit stock, which is also somewhat illiquid and has concentrated ownership, almost as a call option given the potential reward in the off chance that azeliragon were to work […] While our model did not include any value for products other than azeliragon, we note VTVT has some other products in its pipeline. For example, VTVT recently reported positive Phase 1b results for TTP399, a product for Type 1 diabetes.”
Overall, this drug maker certainly has the Street divided, as TipRanks analytics indicate VTVT as a Hold. Based on Based on 5 analysts polled in the last 3 months, four rate a Hold rating on vTv Therapeutics stock, while one issues a Buy.
Selecta Biosciences Selloff Attributed to ‘Sell the News’
Today, Selecta Biosciences (NASDAQ:SELB) investors are scratching their heads as to why the stock tumbled as much as 23%, after the company actually presented new positive data from an ongoing clinical trial of SER-212 in chronic severe gout.
That’s good news for Selecta, but less good news for long-term investors. You see, according to the principle of “buy the rumor, sell the news,” the major catalyst for SELB stock to rise has now been removed, and traders who were awaiting the clinical results have now reaped all the gains they’re going to get from that particular catalyst. Hence, they’re selling the stock today.
Selecta CEO Werner Cautreels stated, “We are very pleased by the clinical activity seen in the data presented today at PANLAR, not only in SEL-212’s ability to control serum uric acid levels but also in the reduced incidence of gout flares compared to the current FDA-approved uricase. We believe that SEL-212 has the potential to change the treatment paradigm for patients with chronic severe gout since there remains a high unmet need for a monthly-dosed therapy that can provide better and sustained serum uric acid control in these patients. Today’s reported data show that approximately 75% of evaluable patients maintained serum uric acid control through three months.”
“We plan to present data from patients receiving five monthly SEL-212 doses at an upcoming medical meeting in the third quarter of this year. We expect these results will expand the 3-month SEL-212 clinical activity shown in today’s PANLAR data across the entire 5-month treatment period of the Phase 2 trial. This will position us well to execute on our Phase 3 trial, which is expected to start later this year. Importantly, the new 4-month PANLAR data provide further evidence that our SVP-Rapamycin platform has the ability to induce immune tolerance, with 91% of evaluable patients maintaining serum uric acid level control after being dosed with pegsiticase only in month three versus 17% who receive pegsiticase without previously receiving the three-monthly doses of SEL-212. We believe this evidence of immune tolerance to a highly immunogenic enzyme has positive implications for the overall platform and its potential for combination with other immunogenic biologic therapies,” Cautreels continued.