SOV Therapeutics announces Successful Phase IIb Study of Oral Testosterone Undecanoate for Treatment of Primary and Secondary Hypogonadism in Adult Males

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Dec 16, 2014, 08:23 ET

MORRISVILLE, N.C., Dec. 16, 2014 /PRNewswire/ -- SOV Therapeutics (www.sovtherapeutics.com) today announced that the company successfully completed a Phase IIb study with its novel oral formulation of testosterone undecanoate (TU). The formulation met both the primary and secondary endpoints that are required for FDA approval of testosterone replacement therapies. The Phase IIb study followed the 90-Day efficacy design used by all recently approved testosterone replacement products.

Features of the SOV Therapeutics TU proprietary formulation include:

Use of phytosterol long-chain fatty acid esters as excipients
Unique PK profile
Low inter- and intra-subject variability in TU exposure, thereby minimizing the risk for testosterone elevations beyond the therapeutic range
Twice-daily dosing with normal or high fat meal requiring minimal or no dose titration
Single dose strength soft gelatin capsule

Results of the SOV Phase IIb trial include:

Cavg in the mid normal T range of 300-1000 ng/dL
No Cmax >1800 ng/dL
No Serious Adverse Events
All subjects (36) completed the study

"Completing the Phase IIb study with our proprietary formulation technology is an important milestone for SOV Therapeutics. We are in the process of scheduling an End of Phase II meeting with FDA and are looking forward to advancing our unique formulation into Phase III clinical development for adult hypogonadal men next year. Availability of an oral form of testosterone replacement therapy could offer significant advantages for patients and their families over the current treatment options," said Dr. Om Dhingra, President and Chief Executive Officer of SOV Therapeutics.

SOV plans to seek strategic partnerships that will support further development and commercialization of its novel oral formulation of TU.

About SOV Therapeutics, Inc.

SOV Therapeutics, Inc., www.sovtherapeutics.com, a privately held biotechnology company, is developing orally bioavailable formulations of testosterone undecanoate, a pro-drug of testosterone, as the basis for testosterone replacement therapy in the treatment of adolescent and adult male hypogonadism. The adolescent indications qualify for orphan designation since there are fewer than 200,000 patients in the United States for each syndrome or condition. SOV received Orphan Drug Designation for the treatment of Constitutional Delay in Growth & Puberty (CDGP) in Adolescent Boys (14-17 years of age) on Feb. 13, 2013.

Media Contacts

Steve Cain
SOV Therapeutics
919-413-0763
[email protected]

Sid Reynolds
Conduit Health Communications
919-612-9755

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SOURCE SOV Therapeutics