TetraLogic Announces the Opening of an IND for SHAPE Gel in Alopecia Areata

Malvern, Pennsylvania, UNITED STATES

MALVERN, Pa., Nov. 2, 2015 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that it has an open U.S. Investigational New Drug application in support of a Phase 2 clinical trial of suberohydroxamic acid (4-methoxycarbonyl) phenyl ester (SHAPE) in approximately forty patients with alopecia areata.

SHAPE is a novel HDAC inhibitor being developed for topical treatment of cutaneous T-cell lymphoma, or CTCL, and is currently being evaluated in a Phase 2 clinical trial. SHAPE is designed to maximize HDAC inhibition locally in the skin with limited systemic exposure.   

Alopecia areata is an autoimmune skin disease resulting in the loss of hair on the scalp and elsewhere on the body.  Alopecia areata occurs in males and females of all ages, but onset often occurs in childhood. Over 6.6 million people in the United States have or will develop alopecia areata at some point in their lives. FDA has identified alopecia areata to be one of the few disease states to be developed under the Patient-Focused Drug Development Initiative based upon multiple criteria including disease severity and unmet medical needs.

"We are excited to advance SHAPE into a second indication and another Phase 2 trial," said J. Kevin Buchi, President and Chief Executive Officer of TetraLogic. "A topical therapy which minimizes systemic exposure could provide an attractive new treatment option to the millions of alopecia areata sufferers."


SHAPE is an HDAC inhibitor being developed for topical use for the treatment of CTCL, and alopecia areata. SHAPE is a novel therapeutic designed to maximize HDAC inhibition locally in the skin with limited systemic exposure. As a result, SHAPE has characteristics that could allow it to be used topically over large body surface areas with minimal systemic absorption. SHAPE's composition of matter patent in the U.S. extends until at least 2028; in addition, SHAPE has been granted U.S. orphan drug designation for CTCL. TetraLogic owns worldwide development and commercialization rights to SHAPE for all indications.

About TetraLogic Pharmaceuticals Corporation

TetraLogic is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. TetraLogic has two clinical-stage product candidates in development: birinapant and SHAPE. Birinapant is currently being tested in Phase 1 and Phase 2 clinical trials for myelodysplastic syndromes (MDS) and solid tumors. SHAPE is currently being tested in a Phase 2 clinical trial for early-stage Cutaneous T-cell Lymphoma (CTCL).

Forward Looking Statements

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or TetraLogic's pre-clinical and clinical development of birinapant, SHAPE and other clinical programs, future expectations, plans and prospects. Although TetraLogic believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. TetraLogic has attempted to identify forward looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 26, 2015 and in our Form 10-Q filed with the SEC on August 5, 2015. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.


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