Latest news with #vasomotorSymptoms
Medscape
21-05-2025
- Health
- Medscape
Fezolinetant Did Not Increase Body Weight or BMI
MINNEAPOLIS — Women taking fezolinetant for menopausal vasomotor symptoms did not experience any significant change in weight or body mass index (BMI) after a year of taking the medication, according to a pooled analysis of previous trial data. 'The most important findings are that fezolinetant does not seem to be associated with any weight gain,' said Nanette F. Santoro, MD, University of Colorado Anschutz Medical Campus in Aurora, Colorado, who presented the data in a poster at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting. 'It looks like it is weight neutral, and if anything, we're seeing a signal that your waist and your body roundness will actually go down in association with the drug because the placebo group didn't have that change in waist circumference,' Santoro told Medscape Medical News . 'And, both doses of fezolinetant, 30 mg and 45 mg, showed a decrease in waist [circumference] and a decrease in body roundness.' Santoro speculated that the modest reduction in waist circumference and body roundness may have been related to better sleep. 'Outside of hot flashes and night sweats, weight gain is the next most common and bothersome complaint in menopausal women,' Chrisandra L. Shufelt, MD, professor of internal medicine and associate director of the Women's Health Research Center for Mayo Clinic in Jacksonville, Florida, told Medscape Medical News . 'This data is reassuring that there's no associated weight gain with fezolinetant, as some of the other nonhormonal medication options come with a side effect of weight gain,' said Shufelt, who was not involved in the research. Greater BMI, body fat, and waist circumference are also associated with greater severity of vasomotor symptoms, the authors noted in their poster. The researchers analyzed data on weight, waist circumference, body roundness, and BMI in women who received fezolinetant for vasomotor symptoms in the phase 3 SKYLIGHT 1, 2, and 4 studies. Since body fat cannot be determined based on BMI, the researchers included the body roundness index (BRI), derived from the ratio of waist circumference to height. The BRI can estimate visceral fat and ranges from 1 to 16, with higher scores indicating wider, rounder bodies with presumably more visceral fat. 'BRI has been found to be superior in estimating risk for clinical endpoints including cardiometabolic disease, kidney disease, and cancer,' the researchers noted. 'Longitudinal studies also show that high BRI was linked to increased risk of all-cause mortality and cardiovascular disease–specific mortality.' The average BRI among US women is 5.86, based on an estimate from the 2018 National Health and Nutrition Examination Survey. The average was 5.87 for people aged 45-65 years and 6.03 for people older than 65 years. The SKYLIGHT 1 and 2 studies were identical randomized controlled studies that ran for 12 weeks, comparing 30 mg and 45 mg of fezolinetant with placebo, plus a 40-week active treatment open-label extension. SKYLIGHT 1 enrolled 522 women, and SKYLIGHT 2 enrolled 500 women. SKYLIGHT 4 enrolled 1830 women who received either 30 mg fezolinetant, 45 mg fezolinetant, or placebo in a double-blind randomized controlled trial lasting 52 weeks. This analysis pooled the results from 2852 total participants, including 2203 women who received fezolinetant (1103 receiving 30 mg and 1100 receiving 45 mg). The placebo group initially included 952 women, but those enrolled in the SKYLIGHT 1 and 2 trials then switched to fezolinetant at 12 weeks for the 40-week extension, so the analysis included their data initially as placebo participants and then in the fezolinetant numbers after 12 weeks. The participants were an average 54 years old and included 15.8%-18.2% Black women and 20.9%-22.2% Latino/Hispanic women across the three groups. At baseline across the groups, their average weight was 75.1-75.7 kg, average BMI was 28.2-28.3, average waist circumference was 90.8-90.9 cm, and average BRI was 4.60-4.63. Average weight remained stable through 52 weeks for those receiving placebo (+0.47 kg), 30 mg fezolinetant (+0.23 kg), and 45 mg fezolinetant (+0.15 kg). Average BMI was similarly stable for the three groups through 52 weeks, but average waist circumference decreased 0.82 cm in the 30-mg fezolinetant group and 0.88 cm in the 45-mg fezolinetant group compared with a 0.15 cm decrease in the placebo group. Similarly, BRI decreased from baseline to 52 weeks by 0.10 in the 30-mg fezolinetant group and by 0.11 in the 45-mg fezolinetant group compared with a 0.01 decrease in the placebo group. If better sleep is potentially involved in the decrease in body roundness and waist circumference, it may also provide more opportunity for increased exercise, Santoro suggested, although that remains speculative since this analysis did not include data on sleep or physical activity. Weight increase was reported as an adverse event in 1.1% of those taking placebo, 2% of those taking 30 mg fezolinetant, and 0.7% of those taking 45 mg fezolinetant. 'BMI has no discernible difference on safety in the pooled SKYLIGHT analysis as measured by overall treatment-emergent adverse events, treatment-emergent adverse events related to study intervention, serious adverse events, serious adverse events related to study intervention, treatment-emergent adverse events of special interest, and liver biochemistry,' the authors reported. The research was funded by Astellas Pharma. Santoro reported financial disclosures involving Astellas Pharma, Ember, MenoGeniX, and Ansa Labs. Three authors are employees of Astellas Pharma. Other authors reported disclosures with Exeltis, HRA Pharma, Novo Nordisk, Pfizer, Abbott, Astellas Pharma, Bayer Pharmaceutical, Besins Healthcare, Fidia Farmaceutici S.P.A., Gedeon Richter, Merck, Scynexis, Shionogi, Theramex, Viatris, and Vichy Laboratories. Shufelt is an adviser for Bayer Pharmaceutical.
National Post
14-05-2025
- Health
- National Post
AbCellera Receives Authorization from Health Canada to Initiate the Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms Due to Menopause
Article content Article content VANCOUVER, British Columbia — AbCellera (Nasdaq: ABCL) today announced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL635, an investigational antibody antagonist targeting neurokinin 3 receptor (NK3R) that is being developed for the non-hormonal treatment of moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. Article content 'Vasomotor symptoms of menopause affect millions of women, with significant impacts on their well-being, and their personal and professional lives,' said Natalya Nazarenko, MD, Executive Medical Director at AbCellera. 'We are excited to advance ABCL635 into a Phase 1 trial and explore it as a potential non-hormonal, long-acting treatment option to address these highly disruptive symptoms.' Article content The Phase 1 study is anticipated to begin in Q3 of 2025 and will evaluate ABCL635's safety, pharmacokinetics, and pharmacodynamics in healthy participants and postmenopausal women with moderate-to-severe VMS. Article content About ABCL635 Article content ABCL635 is a potential first-in-class antibody medicine for the non-hormonal treatment of moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. ABCL635 specifically targets NK3R, a clinically validated G-coupled protein receptor (GPCR) expressed on kisspetin, neurokinin, and dynorphin (KNDy) neurons in the infundibular nucleus of the hypothalamus. ABCL635 is the first program from AbCellera's GPCR and ion channel platform to advance into the pipeline. A Phase 1 clinical trial is anticipated to begin in Q3 of 2025. Article content About AbCellera Biologics Inc. Article content AbCellera (Nasdaq: ABCL) discovers and develops antibody medicines for indications across therapeutic areas, including cancer, metabolic and endocrine conditions, and autoimmune disorders. AbCellera's platform integrates technology, data science, infrastructure, and interdisciplinary teams to solve the most challenging antibody discovery problems. AbCellera is focused on advancing an internal pipeline of first-in-class and best-in-class programs and collaborating on innovative drug development programs with partners. For more information, please visit Article content This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Article content In some cases, you can identify forward-looking statements by the words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors are described under 'Risk Factors,' 'Management's Discussion and Analysis of Financial Condition and Results of Operations,' and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. Article content Article content Article content Article content Contacts Article content Article content Article content
National Post
08-05-2025
- Business
- National Post
AbCellera Reports Q1 2025 Business Results
Article content VANCOUVER, British Columbia — AbCellera (Nasdaq: ABCL) today announced financial results for the first quarter of 2025. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated. Article content Article content 'After completion of a successful first quarter, we are excited to introduce ABCL635 as a potential first-in-class antibody for the non-hormonal treatment of vasomotor symptoms (hot flashes) associated with menopause. ABCL635 is positioned as a next-generation neurokinin 3 receptor (NK3R) antagonist with an improved safety profile and convenient dosing regimen. If successful, we believe it has the potential to be a highly differentiated product in a large and established market,' said Carl Hansen, Ph.D., founder and CEO of AbCellera. 'We ended the quarter with over $800 million in available liquidity to execute on our strategy and anticipate starting Phase 1 clinical trials for both ABCL635 and ABCL575 in the second half of 2025.' Article content Earned $4.2 million in total revenue. Generated a net loss of $45.6 million, compared to net loss of $40.6 million in 2024. Reached a cumulative total of 97 partner-initiated program starts with downstreams. Maintained a cumulative total of 16 molecules to have reached the clinic. Article content AbCellera started discovery on an additional partner-initiated program with downstreams to reach a cumulative total of 97 partner-initiated program starts with downstreams in Q1 2025 (up from 90 on March 31, 2024). AbCellera's partners have advanced a cumulative total of 16 molecules into the clinic (up from 13 on March 31, 2024). Article content Discussion of Q1 2025 Financial Results Article content Revenue – Total revenue was $4.2 million, compared to $10.0 million in Q1 2024. In both periods, the majority of revenues were research fees generated by our partnerships. Research & Development (R&D) Expenses – R&D expenses were $42.5 million, compared to $39.3 million in Q1 2024, reflecting growing investments in internal programs. Sales & Marketing (S&M) Expenses – S&M expenses were $2.8 million, compared to $3.4 million in Q1 2024. General & Administrative (G&A) Expenses – G&A expenses were $16.2 million, compared to $17.4 million in Q1 2024. Net Loss – Net loss of $45.6 million, or $(0.15) per share on a basic and diluted basis, compared to net loss of $40.6 million, or $(0.14) per share on a basic and diluted basis, in Q1 2024. Liquidity – $633 million of total cash, cash equivalents, and marketable securities and approximately $178 million in available non-dilutive government funding, bringing total available liquidity to approximately $810 million to execute on AbCellera's strategy. Article content AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time). Article content The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera's Investor Relations website. A replay of the webcast will be available through the same link following the conference call. Article content About AbCellera Biologics Inc. Article content AbCellera (Nasdaq: ABCL) discovers and develops antibody medicines for indications across therapeutic areas including cancer, metabolic and endocrine conditions, and autoimmune disorders. AbCellera integrates technology, data science, infrastructure, and interdisciplinary teams to solve the most challenging antibody discovery problems. AbCellera is focused on advancing an internal pipeline of first-in-class and best-in-class programs and collaborating on innovative drug development programs with partners. For more information, please visit Article content We regularly review the following key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions. We believe that the following metrics are important to understand our current business. These metrics may change or may be substituted for additional or different metrics as our business develops. Article content Partner-initiated program starts with downstreams represent the number of unique partner-initiated programs where we stand to participate financially in downstream success for which we have commenced the discovery effort. The discovery effort commences on the later of (i) the day on which we receive sufficient reagents to start discovery of antibodies against a target and (ii) the day on which the kick-off meeting for the program is held. We view this metric as an indication of the selection and initiation of projects by our partners and the resulting potential for near-term payments. Cumulatively, partner-initiated program starts with downstream participation indicate our total opportunities to earn downstream revenue from milestone fees and royalties (or royalty equivalents) in the mid- to long-term. Article content Molecules in the clinic represent the count of unique molecules for which an Investigational New Drug, or IND, New Animal Drug, or equivalent under other regulatory regimes, application has reached 'open' status or has otherwise been approved based on an antibody that was discovered either by us or by a partner using licensed AbCellera technology. Where the date of such application approval is not known to us, the date of the first public announcement of a clinical trial will be used for the purpose of this metric. We view this metric as an indication of our near- and mid-term potential revenue from milestone fees and potential royalty payments in the long term. Article content AbCellera Forward-Looking Statements Article content This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Article content In some cases, you can identify forward-looking statements by the words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under 'Risk Factors,' 'Management's Discussion and Analysis of Financial Condition and Results of Operations' and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. 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