Product Summaries
1. TB PATCH DIAGNOSTIC
Status: Enrollment in Peru clinical trial complete; data analysis ongoing. Additional trials in the Philippines are expected to begin in Q3 2007.
Background: The Sequella TB Patch is a point-of-care diagnostic used to diagnose active TB infection. The Patch delivers MPT64, a protein specific to all organisms that cause TB. In those with active, infectious TB, a localized immune response consisting of erythema and/or vesiculation appears 3-4 days after application to the skin.
Product Profile: The Sequella TB Patch diagnostic has the following properties:
- Point-of-care
- Non-invasive, no needles used
- No sample (whole blood or sputum) collection required
- No laboratory processing required
- More specific than the existing TB skin test
- Results unaffected by BCG vaccination, previous TB, latent TB infection, or infection with other Mycobacteria
- Results available in less than four days
R&D Milestones: Enrollment of over 600 patients in a six-center clinical trial in Lima, Peru is complete, and the data for this study are now being analyzed. In three earlier clinical trials enrolling 200 patients in the Philippines and South Africa, the overall specificity was 96% and the overall sensitivity for the diagnosis of active TB disease was 89%, despite marked differences in skin type, color, and disease state.
Sequella licensed the TB Patch diagnostic from the Japan BCG Laboratory and has worldwide commercialization rights excluding Japan. Sequella has developed a method of producing recombinant MPT64 that is conducive to large-scale manufacturing. Process transfer, optimization, and scale-up validation are completed.
Market Opportunity: For more information, please see our TB Patch Backgrounder.
2. SQ109 THERAPEUTIC
Status: Phase I clinical trials
Background: Developed in partnership with the NIH, SQ109 is a new diamine anti-TB drug. It could replace one or more drugs of the existing first-line TB drugs in intensive phase regimen of the WHO-recommended Directly Observed Therapy (DOT).
Product Profile: SQ109 is a small molecule anti-TB drug with a novel structure and mode of action identified from a library of over 63,000 compounds. SQ109 has the following properties:
- Orally bioavailable, concentrates in lung and spleen
- Long half-life
- High potency against Mycobacterium tuberculosis in vitro and in vivo
- Effective as a single drug in murine models of TB infection at 10 mg/kg
- Effective against profoundly drug-resistant TB in vitro
- Has a high degree of specificity for Mycobacteria
- Exhibits synergistic activity with the first-line drugs Rifampicin and Isoniazid in vitro and in vivo.
- Shortens treatment time to cure by 25% in experimental animal models of TB
R&D Milestones: SQ109 has completed all IND-directed preclinical toxicology, pharmacology, and safety studies in two animal species. The IND was filed with the U.S. FDA in August 2006.
Market Opportunity: For more information, please see our SQ109 Backgrounder.
3. DRUG COMPLIANCE MONITOR
Status: Proof-of-principle studies ongoing
Background: The Compliance Monitor is a medical device, a wristwatch that records if and when medication is taken. A light-emitting molecule (fluorophore) is incorporated into the medication as a tracer. When the medication is ingested, the Compliance Monitor noninvasively detects the presence of the fluorophore in the bloodstream through the skin and records the fact that the drug was ingested. Physicians can review drug ingestion history periodically and as required.
Product Profile Attributes:
- Reminds user to take medication
- Non-invasive
- Convenient to wear and cost-effective
- Can ensure drug authenticity and rule out ingestion of counterfeit drugs
- Records drug ingestion for later data retrieval by physician
- Can be integrated into an e-health system
- Uses a proprietary electronic device to transdermally detect a fluorescent excipient incorporated into the drug
R&D Milestones: Sequella is developing the Monitor with funding from an NIH/NIAAA SBIR contract and in partnership with a bioengineering firm. The prototype device has been tested in a rabbit model. The Monitor accurately and noninvasively recorded ingestion of a fluorophore as a tracer in the bloodstream. Proof-of-principle studies in humans are ongoing.
Market Opportunity: Please see our Drug Compliance Monitor Backgrounder.
4. SQ609 THERAPEUTIC
Status: IND-directed pre-clinical toxicology and pharmacology
Background: The drug discovery program at Sequella identified a new class of antibiotic compounds, dipiperidines, with promising in vitro and in vivo anti-TB activity. SQ609 was identified as a lead candidate in this series.
Product Profile Attributes:
- Potent in vitro activity against M. tuberculosis
- Kills M. tuberculosis by interfering with cell wall biosynthesis
- Low in vitro toxicity in cultured mammalian cells
- Orally bioavailable
- Antimicrobial activity in vivo in two different mouse models of TB
- Significantly prolongs therapeutic effect after the withdrawal of drug therapy in mice
- Favorable in vitro safety pharmacology profile
- Has antiviral activity against SARS in vitro.
5. TRANSLOCASE INHIBITOR SERIES
Status: Lead drug candidate selection is SQ641
Background: Sequella is evaluating a series of natural product-derived Translocase I inhibitors for the potential treatment of TB or bacterial pneumonia (Streptococcus pneumoniae). The compounds specifically inhibit Translocase I, an enzyme required for bacterial cell wall synthesis in Mycobacteria and certain other bacteria.
Sequella licensed the Translocase I inhibitors from Sankyo, Ltd (November 2004). Sankyo identified the compound class and performed extensive research and preliminary preclinical development on three selected inhibitors. Sequella has exclusive worldwide rights to the series of Translocase I inhibitors for the treatment of TB and all other indications.