THERATECHNOLOGIES REPORTS POSITIVE 26-WEEK RESULTS FOR ITS SECOND TESAMORELIN PHASE 3 TRIAL
-- RESULTS CONFIRM FINDINGS OF EARLIER STUDY --
Montreal, Canada - June 18, 2008 - Theratechnologies (TSX:TH) today announced positive 26-week results for its confirmatory Phase 3 clinical trial, evaluating the efficacy of the Company's lead compound, tesamorelin, in patients with HIV-associated lipodystrophy. As described in the protocol and agreed to by the Food and Drug Administration (FDA) through the Special Protocol Assessment (SPA) process, the study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. The study met its primary endpoint as well as important secondary endpoints confirming the positive results obtained in the Company's initial Phase 3 study.
"In this second Phase 3 trial, tesamorelin is again proving to be efficacious at reducing VAT, without reducing subcutaneous adipose tissue (SAT), while being well tolerated in patients," commented Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "These confirmatory data are critical to the New Drug Application (NDA) submission that is in preparation to obtain market approval for tesamorelin," concluded Mr. Rosconi.
"Once again, we have met key clinical endpoints, this time treating European as well as North American HIV positive patients," commented Dr. Christian Marsolais, Vice President, Clinical Research of Theratechnologies. "These data add further strength to tesamorelin's product profile for a disease with no approved treatment available. We thank all our employees, collaborators, principal investigators and, particularly, the patients for their participation in this trial," added Dr. Marsolais.
The primary endpoint for the study was VAT reduction while the four secondary endpoints were positive changes in body image (belly appearance distress), triglyceride levels, the total cholesterol to HDL ratio and IGF-1 levels.
Patients treated with tesamorelin for 26 weeks achieved an average of 11% decrease in VAT versus baseline (p<0.001) and 10% versus placebo (p < 0.001). In absolute terms, the average VAT reduction was -20.6 square centimetres (p<0.001 versus placebo). Body fat was preferentially lost in the visceral cavity, with no significant changes in SAT.
This study also demonstrated that treated patients significantly improved their belly appearance distress compared to the placebo group (p= 0.02). This is considered to be an important endpoint because of its implications for patient adherence to HIV regimens.
With respect to lipid profiles, a trend for improvement in triglyceride levels was recorded for the treated group versus placebo (p=0.08) and was significantly different versus baseline (p=0.006). There was no significant impact on the total cholesterol to HDL cholesterol ratio.
IGF-1 mean levels were within physiological range and increased by 73% compared to placebo (p<0.001).
There were no clinically significant differences between the tesamorelin-treated group and placebo in glycemic control. Adverse events with an incidence of more than 10% were: injection site redness (erythema: 14.1% versus 4.8% for placebo); injection site itchiness (pruritis: 10.4% versus 1.6% for placebo); and joint pain (arthralgia: 12.2% versus 11.1% for placebo). The drop out rate for the patients treated with tesamorelin was 25% compared to 27% for the placebo group.
Theratechnologies also presented data yesterday from its first 52-week Phase 3 study testing tesamorelin in HIV-associated lipodystrophy at ENDO, the 90th annual meeting of the Endocrine Society. The presentation reviewed previously disclosed glucose tolerance and lipid data and was made by Dr. Donald Kotler, an investigator for the tesamorelin trial in the United States who is also Chief, Division of Gastroenterology and Liver Disease, St. Luke's-Roosevelt Hospital Center and Columbia University College of Physicians and Surgeons, in New York.
Conference Call and Webcast
The Company will hold a conference call and webcast today at 7:30 a.m. to discuss the results.
To participate, please dial: 1-416-644-3415 or 1-800-733-7571 (toll free). Please dial in five minutes prior to the teleconference in order to ensure your participation. The Webcast will be accessible at the following links: http://www.investorcalendar.com/ and http://www.theratech.com/.
A replay of the conference call will be available from 9:30 a.m. today, June 18, 2008, until June 25, 2008 at 11:59 p.m. at the following number: 1-416-640-1917, pass code 21275389# or 1-877-289-8525, pass code 21275389#. The Webcast will be posted for 10 days at the links indicated above.
Caused by several factors including the antiviral drug regimen and the virus itself, HIV-associated lipodystrophy is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal visceral fat accumulation and loss of subcutaneous fat in the limbs and in the face. Excess VAT and its concomitant metabolic profile have recently been shown to be a risk factor for cardiovascular diseases in HIV patients. There is currently no approved treatment available for HIV-associated lipodystrophy, a serious condition that can stigmatize patients and discourage HIV treatment adherence.
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers innovative drug candidates in order to develop them and bring them to market. The Company targets unmet medical needs in financially attractive specialty markets. Its most advanced program is tesamorelin, now in a confirmatory Phase 3 clinical trial for a serious metabolic disorder known as HIV-associated lipodystrophy. The Company also has other projects at earlier stages of development.
This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation. This forward-looking information includes, but is not limited to, information regarding the efficacy of tesamorelin on the health of patients with HIV-associated lipodystrophy and the capacity of the Company to file an NDA and the likelihood that it obtains market approval for its tesamorelin. Words such as "will", "may", "could", "should", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms or variations of them and the use of the conditional tense as well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Company's control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include, but are not limited to, the risk that patients with HIV-associated lipodystrophy using tesamorelin experience results that may differ from those indicated herein, the risk that the Company encounters problems in preparing the NDA submission and the risk that the FDA does not approve tesamorelin as a drug to treat HIV-associated lipodystrophy. The Company refers potential investors to the "Risks and Uncertainties" section of its annual information form (the "AIF") dated January 29, 2008. The AIF is available at www.sedar.com under the Company's public filings.
Although the forward-looking information contained in this press release is based upon what the Company believes are reasonable assumptions, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information. Certain assumptions made in preparing the forward-looking information include the assumption that patients with HIV-associated lipodystrophy will react positively to the administration of tesamorelin, that the Company will not encounter any problem in preparing its NDA submission and that the FDA will accept the NDA submission and approve tesamorelin for the treatment of HIV-associated lipodystrophy.
Consequently, all of the forward-looking information contained in this press release is qualified by the foregoing cautionary statements, and there can be no guarantee that the results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences or effects on the Company, its business, financial condition or results of operation. The Company does not undertake to update or amend such forward-looking information whether as a result of new information, future events or otherwise, except as may be required by applicable law.