Prothena Discontinues Development of NEOD001 for AL Amyloidosis; PRTA Stock Drops $25.34, or 68.78%, to Close at $11.50 on April 23, 2018
Kehoe Law Firm, P.C. is conducting a securities investigation on behalf of investors of Prothena Corporation plc (NASDAQ: PRTA) to determine whether Prothena and certain of its officers or directors engaged in securities fraud or other unlawful business practices.
Prothena Announces Discontinuance of Development of Drug for Treatment of AL Amyloidosis
On April 23, 2018, Prothena Corporation announced that it
. . . is discontinuing development of NEOD001, an investigational antibody that was being evaluated for the treatment of AL amyloidosis. The decision was based on results from the Phase 2b PRONTO study and a futility analysis of the Phase 3 VITAL study.
Based on the results from the Phase 2b PRONTO study, which did not meet its primary or secondary endpoints, [Prothena] asked the independent data monitoring committee (DMC) of the Phase 3 VITAL study to review a futility analysis of the ongoing VITAL study. The DMC recommended discontinuation of the VITAL study for futility. [Prothena] therefore decided to discontinue all development of NEOD001, including the VITAL study as well as the open label extension studies. (Emphasis added)
The Phase 3 VITAL Study
Prothena, “a clinical stage biotechnology company focused on the discovery and development of novel therapies in the neuroscience and orphan categories,” also announced that
The VITAL Amyloidosis Study was a Phase 3 global, multi-center, randomized, double-blind, placebo-controlled clinical study of NEOD001 vs. placebo in treatment-naïve patients with AL amyloidosis and cardiac dysfunction, with both arms of the study receiving standard of care. The composite primary endpoint was event-based, with all-cause mortality or cardiac hospitalizations as events.
- The futility analysis, based on 103 adjudicated events of the 156 events specified to complete the study, was not statistically significant.
- The hazard ratio was 0.84 favoring NEOD001 vs. control arm. (Emphasis added)
Prothena’s Steep Stock Drop
According to the San Francisco Business Times:
The failure of Prothena Corp.’s main experimental drug in a mid-stage clinical trial led to a massive selloff of its stock Monday, a nearly 70 percent decline in its share price and the decision to stop development of the drug.
. . .
In AL amyloidosis, misfolded amyloid proteins are deposited in tissue, causing progressive organ damage, including heart failure. An estimated 30,000 to 45,000 people in the United States and Europe have been diagnosed with the condition.
Prothena shares had already dropped 47 percent from their 52-week high, Bloomberg noted, after short-sellers last year raised concerns about NEOD-001’s effectiveness, compared to existing treatments, and Prothena’s chief medical officer, Dr. Sarah Noonberg, quit her $465,000 job in February, nine months after joining the company with a $100,000 hire-on bonus.
It was reported by Bloomberg that Prothena’s “shares lost more than two-thirds of their value after having already fallen 30 percent in the prior 12 months.” According to Bloomberg:
Muddy Waters Capital founder Carson Block attacked Prothena last June, saying NEOD001 didn’t help patients much more than existing therapies. Five months later, Kerrisdale Capital Management’s Sahm Adrangi predicted that the drug would fail the Phase 2b study, dubbed ‘Pronto.’ Investor concerns only grew from there as within weeks, they learned that results from a late-stage study of NEOD001 would take a year longer than planned. And then the chief medical officer abruptly resigned in February.
Prothena Corporation Investors and Shareholders
If you purchased, or otherwise acquired, Prothena Corporation stock and have questions or concerns about the securities investigation or your potential legal rights, please contact John A. Kehoe, Esq., (215) 792-6676, Ext. 801, [email protected], complete the form above on the right or e-mail [email protected].