Shares of biopharmaceutical firm Chimerix, Inc. CMRX plunged a massive 81.4% to touch $6.62 yesterday, following the revelation of the company’s failure to meet the primary endpoint of its Phase 3 SUPPRESS trial. The Phase 3 SUPPRESS trial aimed at evaluating the effectiveness of Chimerix’s brincidofovir (also known as CMX001) in preventing clinically significant cytomegalovirus (CMV) infection in hematopoietic cell transplant (HCT) (or stem cell transplant) patients.
Notably, brincidofovir is an investigative oral antiviral drug developed by Chimerix that has shown broad-spectrum antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that affect humans. Unfortunately, the company’s failure to meet the primary endpoint of the Phase 3 SUPPRESS trial, after 24 weeks post the transplant, came as a big blow to its financial stability, as is evident from its dismal share price scenario.
Currently, HCTs are performed on more than 70,000 patients every year across the world, mostly to treat blood cancer or bone marrow cancer patients and sometimes to address genetic disorders. However, the chemotherapy and immune suppression treatment options associated with HCT make such patients highly vulnerable to viral, bacterial and fungal infections.
CMV infection is the most frequent viral complication that sets in after one undergoes HCT. The mortality rate for HCT patients suffering from CMV pneumonia is 50%, even after receiving aggressive treatment. This indicates the dire need of an effective therapeutic solution to treat HCT patients with CMV infection.
To date, there exists no approved therapy for the prevention of CMV in HCT patients. Naturally, there was a high stake on Chimerix’s brincidofovir drug, the success of which would have introduced a revolutionary treatment solution for CMV-affected HCT patients. Alongside, it would have improved the company’s profits from brincidofovir as well.
Per preliminary analysis, management has identified graft-versus-host-disease (GVHD) as the real cause behind the trial’s failure. The trial failed to meet its primary endpoint in CMV infection prevention as well as control of mortality rates in patients receiving brincidofovir after the 14th week, when they were took off the medication. Following the complication, physicians had to administer corticosteroids to these patients.
Unfortunately, GVHD and use of corticosteroids are risky combinations for late stage CMV-affected HCT patients, especially when brincidofovir administration has been discontinued. This possibly led to the failure of the trial.
At present, the company is consulting investigators and other experts for a complete analysis of the Phase 3 SUPPRESS trial data, in an attempt to ultimately establish brincidofovir positive risk-benefit profile for the treatment of adenovirus and smallpox, as well as for use in other populations in need of a novel compound for DNA viral infections. Additionally, the company is also communicating with the U.S. FDA and other regulatory bodies and will share updates, if any, on the brincidofovir clinical program.
Moreover, Chimerix plans to continue the programs testing brincidofovir in serious adenovirus infections and in smallpox. Further, till the availability of complete data from the SUPPRESS trial, including secondary endpoints in other dsDNA viral infections; Chimerix has decided to pause further enrollment in the Phase 3 SUSTAIN and SURPASS trials in kidney transplant recipients.
Currently, Chimerix has a Zacks Rank #3 (Hold). Some better-ranked medical products stocks are Abaxis, Inc. ABAX, INSYS Therapeutics, Inc. INSY and Nxstage Medical, Inc. NXTM. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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