Target Markets

Our drug candidates have broad market potential with applications in Tuberculosis, Fungal Diseases, Crohn’s Disease, Bacterial Pneumonia, and a number of other infectious diseases.

Tuberculosis

A highly contagious infectious disease, TB is caused by the bacterium Mycobacterium tuberculosis.  TB is a global health problem with a large market potential in the established market economies (EME), where there are developed health payer systems that support the financial burden of treatment, as well as in developing countries with growing market economies. According to the 13th annual TB report of the World Health Organization (WHO), there were an estimated 2 billion people infected with TB and 9.27 million new cases of active TB disease worldwide in 2007. Annually, approximately 1.6 million non-HIV infected people die of this disease and an additional 0.5 million HIV infected people also die of TB.  The WHO projects that a staggering 70 million people worldwide will die of TB over the next three decades. 

Specifically for our products, the current U.S. addressable TB-infected population for new TB drugs numbers roughly 365,000 potentially infected people (approximately 15,000 physician-reported active TB cases, 350,000 pediatric, latent and putative TB cases) treated in the private sector. In the EU and Japan, there are approximately 93,000 active TB cases (125,000 in the EU and 45,000 in Japan) that would benefit from improved TB therapeutic products. With these target populations and the current antiquated drug treatment regimens, there is a substantial commercial market for improved TB products in the EME. The current cost of treating an individual with drug-susceptible TB is approximately $25,000. This figure escalates to approximately $250,000 to treat MDR TB. According to the GATB, the current antitubercular drug market is estimated at $410-$470 million annually and will grow to well over $600 million by 2010, with a potential market for a new anti-TB drug that is approximately $316-$432 million.

Treatment
Sequella research and development efforts have generated the largest pipeline of new TB drugs in development.

The current recommended TB treatment regimen requires administration of four first-line TB drugs (Isoniazid, Rifampin, Pyrazinamide, and Ethambutol or Streptomycin) for a minimum of 6 to 9 months. These TB drugs were developed between 1944 and 1970. According to the Journal of the American Medical Association (JAMA): “New drugs are needed to treat TB because the current drug combination has significant disadvantages.” (JAMA 2005; 293: p.2705) There is a need for TB drugs that require shorter treatment duration; work effectively against strains of drug-resistant TB bacilli; deliver an improved side effects profile; and help address medication compliance issues.

Fungal Diseases

Of the 60,000 reported serious hospital-acquired nosocomial systemic fungal infections in the U.S., two yeast (Candida albicans, C. glabrata) and one mold (Aspergillus fumigatis) account for the vast majority of infections. Of these three, the current widely-used antifungals work best against C. albicans. They are far less effective against C. glabrata or A. fumigatis, thereby opening an opportunity for antifungal agents that specifically target these underserved infections, or which include them as a therapeutic target. These niche indications offer an important opportunity to establish a therapeutic following and provide the potential for targeted co-promotion of antifungals with other products frequently used in at-risk groups.

Treatment
Sequella is developing a new class of diamine antifungals that may be useful for treatment of Candida albicans, Candida glabrata and other Candida species. In addition, we have also shown Aspergillus susceptibility to the diamine class of compounds. Our lead clinical stage NCE, SQ109, has activity in vitro on all the nosocomial fungi responsible for serious systemic fungal infections at a level that predicts drug efficacy in vivo, but its best activity is on C. glabrata, responsible for a significant (20-25%) and growing percentage of systemic fungal infections and difficult to treat with the existing drug regimens. In addition, we have a library of several thousand research-stage novel compounds with activity against one or more of the nosocomial pathogens, and 19 compounds that have excellent activity on all three.

Crohn’s Disease

Crohn’s Disease (CD) is a chronic and painful recurrent inflammatory disorder of the intestines that is accompanied by unpredictable bouts of diarrhea, bowel adhesion and obstruction. Long considered an autoimmune inflammatory disorder, current CD therapies (steroids and anti-inflammatory biologics) treat symptoms of overactive inflammation in the gut.

Like many chronic diseases today, evidence is mounting that CD has a currently unrecognized infectious origin. A major suspect for etiologic agent is the NTM M. avium paratuberculosis (MAP). People with CD have 7:1 odds of having a documented presence of MAP in blood or gut tissues than those without CD. MAP also causes Johne’s disease of cattle and ruminants, a disease with similar symptoms as CD.

Treatment
SQ641 is the lead drug candidate from a 7000-compound library of semi-synthetic translocase 1 (TL-1) inhibitors developed as potential treatments for mycobacterial diseases or bacterial pneumonia (Streptococcus pneumoniae). TL-1 is a unique antibacterial target, an enzyme required for cell wall synthesis in all bacteria. SQ641 possesses exceptional activity against all members of the Mycobacteria family of bacteria, including M. tuberculosis, M. avium complex, and M. avium subspecies paratuberculosis, the potential etiological agent of Crohn’s disease.

Bacterial Pneumonia

Disease-causing Nontuberculous Mycobacteria (NTM) are diverse (>10 independent species of environmental Mycobacteria) and cause both pulmonary and non-pulmonary disease in a wide variety of hosts. The most common NTM that cause pulmonary disease are members of Mycobacterium avium complex (MAC), which includes M avium and M. intracellulare. Since NTM are not spread person-to-person, they are not the same public health threat that is TB; they do, however, cause significant morbidity and even mortality. Since the late 1990s, the prevalence of MAC infection has increased. Since it is not a CDC reportable disease, no current reliable estimates are available. Older estimates suggested a NTM disease prevalence of 1.1 per 100,000 persons in the U.S., with the highest numbers in the southeastern states. Researchers and clinicians studying NTM infections estimate that the current incidence is ~5,000 new cases per annum.

Treatment
As with all mycobacterial infections, pulmonary MAC disease requires multidrug therapy. Clarithromycin and azithromycin are the cornerstones of MAC treatment. Combination therapy usually includes a newer macrolide, ethambutol, and a rifamycin for 12 months, with intermittent streptomycin for the first 2 months of therapy in severe disease. Resistance to clarithromycin is increasing and poses a significant challenge to effective therapy. Sequella is developing a new class of drugs called Translocase 1 (TL-1) inhibitors for the potential treatment of NTM pneumonias, TB, or other bacterial pneumonias (Streptococcus pneumoniae). SQ641 is the lead drug candidate from a 7000-compound library of TL-1 inhibitors based on the drug Capuramycin.

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