Fighting a Serious Threat

to Public Health

Our mission: Provide a cure for CDI

Clostridium difficile infection (CDI) is a dangerous disease affecting millions of people worldwide.
Studies show growing incidence and mortality rates.

Morphochem has set out to introduce an innovative intravenous therapy for CDI, based on a novel antibacterial: MCB3681.
We are truly excited about this opportunity to fill an unmet medical need and make a difference for CDI patients.

Moving forward with the clinical development of our compound, we are now headed for Phase 2 studies.
Are you interested in being part of this effort? Get in touch. We are currently exploring partnering options.

The Challenge

Clostridium difficile infection has become a major healthcare problem

Clostridium difficile—also known as C. difficile or C. diff—is a rod-shaped, Gram-positive bacterium which can cause gastrointestinal infections. Transmitted through spores, the disease mainly affects people with weak immune systems. Key risk factors therefore include advanced age, hospitalization, and the intake of medicines that damage the gut flora, such as antibiotics.

Up to 40 percent of patients develop severe forms of CDI, manifested in colonic inflammation, fever, high white-blood-cell count, and/or impaired kidney function. Of this group, about one-fourth are admitted to intensive care and may undergo major surgery due to complications such as ileus (intestinal blockage), toxic megacolon (intestinal dilatation), colonic perforation, or refractory colitis. Usually referred to as “severe and complicated CDI”, these conditions can be fatal for patients as there is no effective cure.

Having identified CDI as a threat to public health with limited treatment options, the U.S. FDA has included C. diff in its list of pathogens where related therapies may be designated as Qualified Infectious Disease Products (QIDP) under the GAIN Act (GAIN: Generating Antibiotics Incentives Now).

Incidence and recurrences are increasing

Studies conducted in Canada, the United States and Europe found that CDI incidence has increased two- to fourfold over the past two decades. Underlying figures are probably conservative, as it appears that CDI is underdiagnosed (and not tested for) in general practice. A French study assumes that up to 60 percent of CDI incidence goes undetected.

Public U.S. statistics recently identified CDI as one of the primary causes of healthcare-associated infections, ranking even above MRSA. In 2011, almost half a million Americans were newly infected; over 29,000 patients died within 30 days of diagnosis—more than twice the number of annual deaths from HIV/AIDS.

Recurrences have tripled over the past decade, due to increased (mis-) use of antibiotics, the growing numbers of immunosuppressed and/or elderly patients, and the emergence of new, hypervirulent C. diff strains. The latter now account for over 50 percent of cases. At present, 20 to 30 percent of CDI patients in the U.S. and Europe are expected to relapse—an alarming development.

For 2021, experts forecast over 1.5 million CDI infections for the U.S. and Europe combined and even higher numbers for Asia. The threat to public health is clearly increasing.

CDI brings enormous costs for healthcare systems

CDI involves considerable costs for healthcare systems. According to studies conducted in 2008, the disease caused $4.8 billion in excess costs in U.S. acute-care facilities alone. Other studies estimate CDI-related excess costs to range between $3,000 and $30,000 per patient.

As almost all available analyses have focused on inpatients, the total cost burden on the healthcare system is likely to be underestimated. After all, a sizeable part of it has yet to be quantified: Figures do not include patients discharged to long-term care, the numerous instances of CDI onset in long-term care facilities, recurrent episodes, and people treated in outpatient settings. Recurrences in particular are associated with excessive cost, mostly attributable to significantly extended hospital stays.


Bacteria growing in a petri dishes


The Opportunity



We plan to introduce an effective therapy for severe CDI

Most patients diagnosed with mild to moderate CDI are given oral antibiotics, such as metronidazole, vancomycin, and/or fidaxomicin. Dosages are usually increased when the disease reaches a severer stage. For patients experiencing aggressive complications—that is, one in every ten—there is presently no proven effective therapy. Major and life-changing surgery such as colectomy is often inevitable.

Our compound MCB3681 is targeted at this particular group. We are developing an intravenous therapy for severe CDI, which should lead to improved cure rates and a major improvement in patients‘ quality of life.

IV therapy offers advantages compared to oral

Severe CDI is typically associated with profuse watery diarrhea causing accelerated excretion of any orally administered drug. When the patient’s condition is further complicated by colonic dilation, blockage, perforation, or refractory inflammation, oral therapy tends to be ineffective or not feasible at all: Patients usually have difficulties swallowing, and even if the intake of tablets is possible, conditions such as ileus or toxic megacolon may slow or block the passage through the digestive system. As a result, sufficient concentrations of antibacterials in the intestine are difficult to achieve with oral medication.

Intravenous therapy, by contrast, is expected to transport the antibacterial through the blood stream and intestinal wall and/or through the biliary system into the gut, thereby providing better access to the site of infection as well as the extended drug exposure needed for efficacy. Only a few of the antibacterials currently known generate sufficiently high fecal concentrations after intravenous administration and are active against C. diff.

No approved intravenous treatment available to date

At present, two intravenous antibiotics are administered against severe CDI where oral treatment is impossible: IV metronidazole and tigecycline. Although both lack regulatory approval for CDI, they are listed as therapy options in the current treatment guidelines issued by professional associations. These recommendations, however, are based on weak and low-quality evidence—simply because there is very little data on effective treatment for severe and complicated CDI.

The fact that these intravenous therapies are recommended despite their lack of approval shows that 1) intravenous treatment is considered a necessity by the medical community, and 2) there is no better intravenous treatment available to date. In short, an efficacious, approved intravenous therapy for severe CDI will fill an unmet medical need.

The Project

Development is progressing well

Our compound MCB3681 is a small-molecule antibacterial of a new class. It is targeted at the intravenous therapy of severe CDI—the first to undergo clinical development and pursue regulatory approval in the United States and Europe.

In pre-clinical studies, MCB3681 has demonstrated remarkable Gram-positive antimicrobial activity. It was particularly effective against C. diff clinical isolates (N = 335), regardless of both their virulence—including hypervirulent NAP1—and their resistance to other antibacterials. We detected no cross-resistance to any established class of antibacterials. (See our Downloads and Links section for further details.)

Due to its narrow Gram-positive spectrum and favorable impact on the commensal flora, MCB3681 has the potential to target C. diff bacteria selectively and provide a cure for severely ill CDI patients.

Phase 1 results have been encouraging

Safety and tolerability of MCB3681 were established in three Phase 1 studies. In a multiple-dose Phase 1b study (conducted at the Karolinska Institute in Stockholm, Sweden) the substance achieved high concentrations in the feces of healthy volunteers, resulting in a pronounced antibacterial effect on Clostridia and other Gram-positive species. It did spare Gram-negative species, including the bacteroides that protect the intestine against colonization with harmful microorganisms. This pharmacodynamic effect can be considered a Proof of Principle that MCB3681 is active under clinically relevant conditions.

Next steps are underway

In May 2016, we submitted to the U.S. Food and Drug Administration (FDA) an Investigational New Drug (IND) application for MCB3837, the intravenous prodrug of active substance MCB3681. The FDA responded favorably.

At present we are preparing a Phase 2 study for intravenous administration of MCB3837 to patients diagnosed with severe CDI. The study is planned to start in the second half of 2016.

Government incentives available for novel antibacterials

Under a national plan to combat antibiotic-resistant bacteria, substantial grants and funding options have been made available by U.S. public institutions such as BARDA and NIH. In addition, the GAIN Act* grants five additional years of market exclusivity and priority review to new antibiotics designated as Qualified Infectious Disease Products (QIDP). Further regulatory and reimbursement initiatives have been proposed and will be discussed in the U.S. government this year.

European authorities are considering similar supportive measures to accelerate the development of antibiotics addressing unmet medical needs.


*GAIN is short for Generating Antibiotics Incentives Now. The GAIN Act forms part of the Food and Drug Administration Safety and Innovation Act, FDASIA.


Pipette adding red fluid to the one of test-tubes on light background










Downloads and Links

The Company

Meet the Morphochem team

Morphochem is a clinical-stage pharmaceutical company located in Munich, Germany. We are a 100-percent subsidiary of Biovertis AG, which is headquartered in Vienna, Austria. Biovertis’s major shareholder is TVM Capital.

At Morphochem, we are committed to the development and commercialization of MCB3681, a compound that will provide the basis for an innovative intravenous therapy for severe Clostridium difficile infections. Our lean operations reflect our dedication to this purpose.


Board members

Prof. Ernst Günter Afting, MD, PhD

Chairman, Supervisory Board

Prof. Dr. med. Thomas D. Szucs, MPH, MBA, LLM

Vice Chairman, Supervisory Board

Dr. Helmut Schuehsler

Member, Supervisory Board

Dr. Günter Schmid

Member, Supervisory Board

Dr. Jens Teichmann


Carsten Dehning


Contact us



As outlined here, MCB3681 has the potential to solve an urgent medical problem and address a sizeable market.

Are you interested in learning more about the project? Would you like to join us? Get in touch. We will reply as soon as we can.

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