Latest news with #ChristianMarsolais
Hamilton Spectator
02-05-2025
- Health
- Hamilton Spectator
Theratechnologies Presents Novel Data at ACTHIV 2025 Underscoring Importance of Managing Excess Visceral Abdominal Fat (EVAF) in People with HIV
VAMOS analysis highlights link between EVAF and reduced muscle quality Case series reports success with combination tesamorelin/GLP-1 receptor agonist therapy MONTREAL, May 02, 2025 (GLOBE NEWSWIRE) — Theratechnologies Inc. ('Theratechnologies' or the 'Company') (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced two poster presentations at the 19th Annual American Conference for the Treatment of HIV (ACTHIV 2025), taking place May 1-3 in Chicago, Ill. Both presentations focus on issues surrounding excess visceral abdominal fat (EVAF), a common comorbidity in people with HIV (PWH). One poster presents a new analysis of data from the Visceral Adiposity Measurement and Observations Study (VAMOS), in which EVAF was associated with reduced muscle quality in aging PWH. VAMOS is the first trial designed to improve the understanding of the impact of EVAF on cardiovascular disease, steatotic liver disease, insulin resistance, and other metabolic parameters in PWH. The second presentation reports on a first-of-its-kind case series in which the combination of tesamorelin and glucagon-like peptide-1 (GLP-1) receptor agonist (RA) therapy was highly effective in reducing both EVAF and obesity in a real-world setting. 'We are proud to continue our exploration into the complexities of excess visceral abdominal fat in people with HIV,' said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. 'As people with HIV live longer, analyses such as the data we are presenting at ACTHIV are critical to addressing this population's evolving health needs. Our research adds to the growing understanding that body composition, most importantly EVAF, is a key factor in aging-related functional decline in HIV, and we are committed to investigating this complex relationship.' VAMOS Analysis Poster Title: Reduced Muscle Quality is Highly Prevalent in Aging People with HIV (PWH) and is Associated with Excess Visceral Abdominal Fat (EVAF) First Author: Zachary Henry, DO, AIDS Healthcare Foundation, Fort Lauderdale, Fla. In the latest analysis from the multicenter VAMOS study, researchers investigated how EVAF, compared to subcutaneous fat, is associated with muscle quality in PWH on modern anti-retroviral regimens, and explored potential drivers of this relationship. Among the 170 participants, EVAF prevalence was 58%. Muscle quality was found to be lower with increasing age of participants (r= -0.465; p<0.0001), but was not significantly correlated with body mass index (BMI) (r= -0.118; p=0.124). EVAF was associated with lower skeletal muscle quality, as demonstrated by lower muscle mean attenuation (r= -0.445; p<0.0001). The researchers concluded that increased levels of visceral fat – more so than subcutaneous fat or increasing BMI – strongly correlate with reduced skeletal muscle quality, which may amplify age-related functional declines. Tesamorelin/GLP-1 RA Case Series Poster Title: High Levels of Treatment Success Seen with Combined Use of Tesamorelin and GLP1-RAs in People with HIV First Author: Daniel Lee, MD, University of California San Diego Department of Medicine, San Diego, Calif. In the case series, investigators reported on the real-world use of tesamorelin for the treatment of EVAF in PWH, in combination with GLP-1 RAs, which are commonly used for diabetes and obesity management in the general population. Among the seven PWH evaluated in the case series, tesamorelin was initiated first in all cases to address EVAF, with a mean reduction in waist circumference of 1.3 inches. The principal reasons for adding a GLP-1-RA included improving BMI and diabetic control. Following at least six months of combination therapy, patients saw mean reductions in weight (-13 pounds), BMI (-2.2 kg/m2), and waist circumference (-3.4 inches), with six of the seven patients achieving their metabolic and body composition goals. Combination therapy is ongoing in most of the patients (6/7). This is the first known report of the dual use of these agents in PWH, highlighting their complementary but distinct mechanisms of action. 'The combination of tesamorelin and GLP-1 medications represents a new frontier in metabolic care for people with HIV,' noted Dr. Marsolais. 'By distinguishing between and targeting both excess visceral abdominal fat and generalized obesity, treatment strategies can be tailored to address the specific needs of people living with HIV.' Both posters can be found at and following the conference. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at , on SEDAR+ at and on EDGAR at . Follow Theratechnologies on LinkedIn and X . Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the 'Forward-Looking Statements'), within the meaning of applicable securities laws, that are based on our management's beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as 'may', 'will', 'should', 'could', 'promising', 'would', 'outlook', 'believe', 'plan', 'envisage', 'anticipate', 'expect' and 'estimate', or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the Company's commitment to investigate the relationship between body composition and aging and the tailoring of treatment strategies for PWH. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the duration of treatment and the responses to the administered drugs by PWH. Some of the risks include that PWH may not respond similarly when they take medicines and results may differ from what those were observed and reported through VAMOS and the tesamorelin/GLP-1 RA case series. The Company refers current and potential investors to the 'Risk Factors' section of the Company's Annual Information Form filed on Form 20-F dated February 26, 2025 available on SEDAR+ at and on EDGAR at under Theratechnologies' public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company's expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries: Julie Schneiderman Senior Director, Communications & Corporate Affairs communications@ 514-336-7800 Investor Inquiries: Joanne Choi Senior Director, Investor Relations jchoi@ 551-261-0401
Yahoo
02-05-2025
- Health
- Yahoo
Theratechnologies Presents Novel Data at ACTHIV 2025 Underscoring Importance of Managing Excess Visceral Abdominal Fat (EVAF) in People with HIV
VAMOS analysis highlights link between EVAF and reduced muscle quality Case series reports success with combination tesamorelin/GLP-1 receptor agonist therapy MONTREAL, May 02, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ('Theratechnologies' or the 'Company') (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced two poster presentations at the 19th Annual American Conference for the Treatment of HIV (ACTHIV 2025), taking place May 1-3 in Chicago, Ill. Both presentations focus on issues surrounding excess visceral abdominal fat (EVAF), a common comorbidity in people with HIV (PWH). One poster presents a new analysis of data from the Visceral Adiposity Measurement and Observations Study (VAMOS), in which EVAF was associated with reduced muscle quality in aging PWH. VAMOS is the first trial designed to improve the understanding of the impact of EVAF on cardiovascular disease, steatotic liver disease, insulin resistance, and other metabolic parameters in PWH. The second presentation reports on a first-of-its-kind case series in which the combination of tesamorelin and glucagon-like peptide-1 (GLP-1) receptor agonist (RA) therapy was highly effective in reducing both EVAF and obesity in a real-world setting. 'We are proud to continue our exploration into the complexities of excess visceral abdominal fat in people with HIV,' said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. 'As people with HIV live longer, analyses such as the data we are presenting at ACTHIV are critical to addressing this population's evolving health needs. Our research adds to the growing understanding that body composition, most importantly EVAF, is a key factor in aging-related functional decline in HIV, and we are committed to investigating this complex relationship.' VAMOS Analysis Poster Title: Reduced Muscle Quality is Highly Prevalent in Aging People with HIV (PWH) and is Associated with Excess Visceral Abdominal Fat (EVAF) First Author: Zachary Henry, DO, AIDS Healthcare Foundation, Fort Lauderdale, Fla. In the latest analysis from the multicenter VAMOS study, researchers investigated how EVAF, compared to subcutaneous fat, is associated with muscle quality in PWH on modern anti-retroviral regimens, and explored potential drivers of this relationship. Among the 170 participants, EVAF prevalence was 58%. Muscle quality was found to be lower with increasing age of participants (r= -0.465; p<0.0001), but was not significantly correlated with body mass index (BMI) (r= -0.118; p=0.124). EVAF was associated with lower skeletal muscle quality, as demonstrated by lower muscle mean attenuation (r= -0.445; p<0.0001). The researchers concluded that increased levels of visceral fat – more so than subcutaneous fat or increasing BMI – strongly correlate with reduced skeletal muscle quality, which may amplify age-related functional declines. Tesamorelin/GLP-1 RA Case Series Poster Title: High Levels of Treatment Success Seen with Combined Use of Tesamorelin and GLP1-RAs in People with HIV First Author: Daniel Lee, MD, University of California San Diego Department of Medicine, San Diego, Calif. In the case series, investigators reported on the real-world use of tesamorelin for the treatment of EVAF in PWH, in combination with GLP-1 RAs, which are commonly used for diabetes and obesity management in the general population. Among the seven PWH evaluated in the case series, tesamorelin was initiated first in all cases to address EVAF, with a mean reduction in waist circumference of 1.3 inches. The principal reasons for adding a GLP-1-RA included improving BMI and diabetic control. Following at least six months of combination therapy, patients saw mean reductions in weight (-13 pounds), BMI (-2.2 kg/m2), and waist circumference (-3.4 inches), with six of the seven patients achieving their metabolic and body composition goals. Combination therapy is ongoing in most of the patients (6/7). This is the first known report of the dual use of these agents in PWH, highlighting their complementary but distinct mechanisms of action. 'The combination of tesamorelin and GLP-1 medications represents a new frontier in metabolic care for people with HIV,' noted Dr. Marsolais. 'By distinguishing between and targeting both excess visceral abdominal fat and generalized obesity, treatment strategies can be tailored to address the specific needs of people living with HIV.' Both posters can be found at and following the conference. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at on SEDAR+ at and on EDGAR at Follow Theratechnologies on LinkedIn and X. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the 'Forward-Looking Statements'), within the meaning of applicable securities laws, that are based on our management's beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as "may", "will", "should", "could", 'promising', 'would', "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the Company's commitment to investigate the relationship between body composition and aging and the tailoring of treatment strategies for PWH. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the duration of treatment and the responses to the administered drugs by PWH. Some of the risks include that PWH may not respond similarly when they take medicines and results may differ from what those were observed and reported through VAMOS and the tesamorelin/GLP-1 RA case series. The Company refers current and potential investors to the 'Risk Factors' section of the Company's Annual Information Form filed on Form 20-F dated February 26, 2025 available on SEDAR+ at and on EDGAR at under Theratechnologies' public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company's expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@ Investor Inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@ in to access your portfolio
Yahoo
25-03-2025
- Health
- Yahoo
Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
New, improved formulation set to replace EGRIFTA SV® MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ('Theratechnologies' or the 'Company') (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename EGRIFTA WR™. Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. The new formulation, EGRIFTA WR™, is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the current F4 formulation, sold in the U.S. as EGRIFTA SV®, which is reconstituted daily. Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR™ to the original F1 formulation of tesamorelin for injection (previously sold under the trade name EGRIFTA®). The most commonly reported adverse reactions of EGRIFTA WR™ include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. 'We are pleased to offer this improved, more convenient version of tesamorelin for injection to help people with HIV and their healthcare providers more effectively manage comorbidities like lipodystrophy, which today often presents as central adiposity,' said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. 'EGRIFTA WR™ enables a simplified administration and an improved patient experience, which are important considerations for people living with HIV.' EGRIFTA WR™ will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. The product can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution. 'Central adiposity, characterized by the accumulation of excess visceral abdominal fat (EVAF), is a common complication for people with HIV that may result from the virus itself, from certain older antiretrovirals and from a reduction in growth hormone concentrations,' commented David Alain Wohl, MD, Professor at the Institute of Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill. 'Given the significant impact of EVAF on health and quality of life for many of our patients with HIV, and the importance of maintaining lean muscle mass especially as we age, a new, more conveniently dosed formulation of tesamorelin is a welcome advancement.' EGRIFTA WR™ will be manufactured at a new, U.S.-based contract drug manufacturing organization (CDMO). The new formulation, which is patent protected in the U.S. until 2033, is set to replace EGRIFTA SV®. Further information about EGRIFTA WR™, including full prescribing information, instructions for use, and important safety information is available here. Important Safety Information EGRIFTA WR™ (tesamorelin for injection) is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy*. EGRIFTA WR™ is a growth hormone- releasing factor (GHRF) analog that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR™ has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA WR™ is not indicated for weight loss management as it has a weight- neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR™. Contraindications: Do not use EGRIFTA WR™ if a patient: Has disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. Has active cancer. Is allergic to tesamorelin or any of the ingredients in EGRIFTA WR™. Is pregnant or planning to become pregnant. The most commonly reported adverse reactions of EGRIFTA WR™ include: arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. Healthcare providers and patients are encouraged to report adverse events at 1-833-23THERA (1-833-238-4372). You are encouraged to report side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Refer to this link for the full prescribing information, patient information and instructions for use for EGRIFTA WR™. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at on SEDAR+ at and on EDGAR at Follow Theratechnologies on Linkedin and X. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the 'Forward-Looking Statements') within the meaning of applicable securities laws, that are based on management's beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as 'may', 'will', 'should', 'could', 'promising', 'would', 'outlook', 'believe', 'plan', 'envisage', 'anticipate', 'expect' and 'estimate', or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the convenience of the F8 formulation; (ii) the experience of using the F8 formulation for patients; and (iii) the transition to the F8 formulation from EGRIFTA SV®. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the marketplace will accept this new formulation of EGRIFTA SV®; and (ii) the F8 formulation of tesamorelin for injection will be reimbursed by private and public payors. Forward-Looking Statements assumptions are 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 Statements. These risks and uncertainties include, but are not limited to: (i) patients and physicians do not adopt the F8 formulation of tesamorelin for injection; (ii) the F8 formulation of tesamorelin for injection does not get reimbursement coverage from private and/or public payors; and (iii) the transition to the F8 formulation is delayed due to various matters, including delays associated with the availability of materials required to commercialize the F8 formulation. The Company refers current and potential investors to the 'Risk Factors' section of the Company's annual information form filed under Form 20-F dated February 26, 2025 available on SEDAR+ at and on EDGAR at under Theratechnologies' public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company's expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@ Investor Inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@
Yahoo
14-02-2025
- Business
- Yahoo
Theratechnologies Resumes Distribution of EGRIFTA SV®
MONTREAL, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ('Theratechnologies' or the 'Company') (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today announced that it has resumed distribution of EGRIFTA SV® (tesamorelin for injection), following correspondence from the U.S. Food and Drug Administration (FDA) that allows the Company to release two recently manufactured batches of EGRIFTA SV®. The product is ready for immediate shipment to network pharmacies. 'We remain committed to providing EGRIFTA SV® to people with HIV and we truly appreciate the FDA's collaboration to get the treatment back to the patients who rely on it,' said Christian Marsolais, PhD, Senior Vice President and Chief Medical Officer at Theratechnologies. Review of the Company's Prior Approval Supplement by the FDA is ongoing with an action goal date of April 18, 2025. EGRIFTA SV® is distributed in the United States only. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at on SEDAR+ at and on EDGAR at Follow Theratechnologies on Linkedin and X. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the 'Forward-Looking Statements') within the meaning of applicable securities laws, that are based on management's beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as 'may', 'will', 'should', 'could', 'promising', 'would', 'outlook', 'believe', 'plan', 'envisage', 'anticipate', 'expect' and 'estimate', or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the review of the Prior Approval Supplement (PAS) within the timelines announced herein; and (ii) the provision of EGRIFTA SV® to people with HIV. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the PAS will be approved by the FDA; (ii) the review of the PAS will be completed within the timelines disclosed herein; (iii) current market demand for EGRIFTA SV® has not been adversely impacted by the drug shortage; and (iv) the Company's third party manufacturer will be able to continue the manufacture of EGRIFTA SV® to meet patients demand . Forward-Looking Statements assumptions are 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 Statements. These risks and uncertainties include, but are not limited to: (i) FDA's review of the PAS not being completed by April 18, 2025; (ii) non-approval of the PAS; (iii) issuance of questions as part of the PAS review by the FDA resulting in delays in completing the PAS review and resulting in delays beyond April 18, 2025, to release additional batches of EGRIFTA SV®, if need be; (iv) issuance of a complete response letter following the filing of the PAS as a result of the manufacturing site being classified as Official Action Indicated preventing the Company from releasing additional batches of EGRIFTA SV®, unless new authorizations similar to the one announced herein are obtained from the FDA; and (v) a decrease in demand for EGRIFTA SV® due to the recent shortage adversely impacting the resumption of the commercialization of EGRIFTA SV®;. The Company refers current and potential investors to the 'Risk Factors' section of the Company's Form 20-F dated February 21, 2024 available on SEDAR+ at and on EDGAR at under Theratechnologies' public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company's expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@ Investor inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@
