By Jim Shrine
An interim analysis in the Phase III trial of Alpha-Beta Technology Inc.'s Betafectin showed insufficient efficacy to warrant continuation of the study, a result that may signal the beginning of the end for the company.
The Worcester, Mass., firm had almost everything riding on the outcome of the study, which was testing the non-antibiotic glucan polymer's ability to prevent serious infections in upper gastrointestinal surgery patients. This indication was selected after a 1997 Phase III trial, which included colorectal procedures, failed to achieve statistical significance overall, but did achieve it in the narrower indication.
"We're all dumbfounded," said Spiros Jamas, Alpha-Beta's president and CEO. "We don't know why there was a difference in the previous study and this study. Clinical research has a lot of inherent variability. We had the same patient population; they were very similar across a range of criteria. That gave us a lot of confidence we'd have a positive outcome at the interim."
Although the company has not released its end-of-year financial statements, its previous cash position ($4.8 million as of Sept. 30, plus a $1.5 million October financing) and burn rate ($1.5 million per month) indicate it is almost out of money. Alpha-Beta has about 20.8 million shares outstanding.
The company's stock (NASDAQ:ABTI) did not trade Friday, and NASDAQ said the shares would not resume trading until more information was provided by Alpha-Beta, which ended the day unchanged at about 72 cents per share.
Alpha-Beta will cut staff from about 92 employees to about 10, Jamas said.
"We'll follow up with specific details in the next couple of weeks," he said. "The goal is to retain a small antifungal research group. We have some funded programs in that area, and our goal is to complete those programs, and try to out-license or sell the antifungal technology.
"We also will evaluate to what extent we can continue operations and the best way to handle the remaining assets of the company," he said. "We will make a subsequent announcement, probably within a few weeks, to provide more details on what our next steps will be."
The double-blind, placebo-controlled Phase III study, in which Alpha-Beta planned to enroll 618 patients, was stopped after an independent monitoring board of three physicians examined data from 312 patients. Those undergoing upper gastrointestinal (non-colorectal) surgeries at risk of post-operative infections were given placebo or 1 milligram per kilogram of body weight of Betafectin PGG-glucan. The primary endpoint was reduction of serious infections or death after surgery, with secondary endpoints including length of hospital stay, days in intensive care unit, and days of antibiotic use.
Had the interim results been positive, the company was planning to quickly secure bridge financing, and then seek enough funds to finish the trial, Jamas said.
Alpha-Beta's first Phase III trial of Betafectin, with nearly 1,200 patients, included similar endpoints. While statistical significance was not achieved overall, there was a 39 percent reduction of serious post-operative infections in non-colorectal surgeries (gastric, biliary, pancreatic and small bowel procedures). Favorable trends also were seen in secondary endpoints. (See BioWorld Today, Aug. 5, 1997, p. 1.)
The trial disappointment led to a workforce reduction of about 60 of the company's 160 employees, and an immediate 43 percent drop in the stock price, to $6.125.
Alpha-Beta's antifungal research program centers on discovery of direct inhibitors of fungal cell-wall synthesis. It also has developed a rapid diagnostic test to detect and monitor systemic fungal infections.
Jamas said the company has validated three biological targets and identified some "hits" with antifungal activity through screening technology. "We will look at what is the best way to regain some value from that in the near future," he said. n