Munich, Germany, June 22, 2016 — Morphochem, a private clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for the company’s novel product candidate MCB3837. MCB3837 is the intravenous (IV) prodrug of the antibacterial MCB3681 which is targeted at the treatment of Clostridium difficile infection (CDI).
“We are delighted to have received FDA acceptance for our IND in the U.S. and look forward to initiating our proof-of-concept Phase 2 clinical study” says Dr. Thomas Kapsner, M.D., Morphochem’s Chief Executive Officer. “Today, there is no approved IV antibacterial for the treatment of CDI. Since many patients with severe CDI cannot be treated orally we are facing a high unmet medical need. Our goal is to develop an effective IV treatment option and improve the outcome for patients with life-threatening CDI.”
CDI is a serious threat to public health according to a CDC report published in 2013. Between 500,000 and 700,000 CDI cases are diagnosed per year in the US alone with up to 30,000 patients dying from CDI each year. The situation in Europe is similar.
Morphochem is planning to initiate a proof-of-concept Phase 2 clinical trial of MCB3837/3681 in severe CDI patients in H2 2016. As part of its partnering efforts Morphochem has retained Torreya Partners, based in London.
MCB3837 is a water-soluble injectable small molecule prodrug of the active substance MCB3681, which is being specifically developed for the IV treatment of CDI. Three Phase 1 clinical studies have shown MCB3837/MCB3681 to be safe and tolerable. In pre-clinical studies, MCB3681 demonstrated remarkable Gram-positive antimicrobial activity against C. difficile pathogens, including the highly virulent BI/NAP1/027 strain, with no cross-resistance to any established class of antibacterial. In a multiple-dose Phase 1b study, high concentrations of MCB3681 were observed in the feces of healthy volunteers, resulting in a pronounced effect on clostridia and other Gram-positive species while sparing Gram-negative species, including bacteroides that protect the intestine against colonization with harmful pathogens potentially causing gastrointestinal infections. Due to this strong pharmacodynamic effect in humans, its narrow Gram-positive spectrum, and its favorable impact on the commensal flora, MCB3681 has the potential to target C. difficile pathogens selectively and effectively.
About C. difficile Infection
Clostridium difficile (C. difficile) is a Gram-positive bacterium that causes gastrointestinal infections. The toxins it produces lead to inflammation of the colon and severe diarrhea, and in very serious cases the disease can be fatal. Epidemiology of C. difficile infections has worsened significantly in recent years, with increasing incidence, severity of cases, and mortality rates. In 2013, the U.S. Centers for Disease Control classified C. difficile as an immediate and urgent public health threat requiring aggressive action. Mostly occurring in hospitals and long-term care facilities, the disease is estimated to have increased healthcare costs by $4.8 billion in 2008 in acute care alone.
The most important risk factor for developing CDI is the use of antibiotics, as they suppress the normal bowel flora and provide a niche environment for C. difficile to flourish. Older age is the second most important risk factor. Up to 40 percent of CDI patients develop severe and severe-complicated CDI, which is associated with significantly higher morbidity and mortality rates. Although treatment of CDI is dominated by oral therapies, oral treatment is not possible for a significant portion of severely ill patients as they may have difficulty swallowing or digesting tablets, and problems retaining the medication in or moving along the gastrointestinal tract. Alternatives are very limited, resulting in a high unmet need for an effective, approved IV therapy to treat these patients. There is currently no approved IV treatment option available for CDI.
Morphochem Aktiengesellschaft für kombinatorische Chemie is a private clinical-stage pharmaceutical company located in Munich, Germany, and a 100-percent subsidiary of Biovertis AG, which is headquartered in Vienna, Austria. Biovertis’s major shareholder is TVM Capital Life Science. Morphochem is fully dedicated to the development and commercialization of MCB3837/MCB3681, which the company hopes to introduce as the first approved intravenous therapy for severe Clostridium difficile infections.
Torreya Partners is a leading corporate finance advisory boutique specializing in the pharmaceutical and biotechnology industries. With offices in New York and London, the firm is top ranked in the sector worldwide for M&A and partnering advisory.
About TVM Capital Life Science
TVM Capital Life Science is providing venture capital to the international pharmaceutical, biopharmaceutical and medical technology industries with more than 30-years of transatlantic investment track record and in excess of US$1.3bn under management. TVM Capital Life Science currently invests from its 7th fund generation, TVM Life Science Ventures VII, with an integrated team of investment professionals from Munich and Montreal.
About TVM Capital Group
TVM Capital is a group of globally acting venture capital and private equity firms with an operating track record of 30 years. Investment teams have financed more than 250 emerging companies across several industries since 1984. During the last 15 years the firm has become increasingly specialized in the most attractive and high-growth verticals in the broader healthcare markets, with focus areas in financing innovative products and technologies in the European and U.S. biopharmaceutical and medical device markets, as well as healthcare services in Emerging Markets. TVM Capital funds operate globally with dedicated life science venture capital funds advised by group members TVM Life Science Management in Montréal and in Munich, and its healthcare private equity fund managed by TVM Capital Healthcare Partners out of Dubai.
Elhan Webb, CFA, firstname.lastname@example.org