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Caliway Announced CBL-514 Phase 2 Study for Cellulite Treatment Met All Primary and Secondary Endpoints
- CBL-514 is the first product to treat cellulite at the raised areas.
- Currently, there is no effective and safe cellulite treatment on the market. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.
- CBL-0201EFP Phase 2 study demonstrated CBL-514 statistically significant efficacy in reducing cellulite severity scores at 4 and 12 weeks after treatment.
- Over 50% of participants experienced at least one level of improvement in cellulite severity 12 weeks after the final CBL-514 treatment evaluating with the modified Hexsel Cellulite Severity Scale among 4 levels of severity.
- CBL-514 is under development for multiple indications, including Cellulite, Local Fat Reduction (currently in Phase 2b), and Durum’s disease (currently in Phase 2), which brought Caliway the Fast Track Designation and the Orphan Drug Designation by the FDA in Feb. 2024.
NEW TAIPEI CITY, April 25, 2024 /PRNewswire/ — Caliway Biopharmaceuticals (Caliway) today announced the topline results of the CBL-0201EFP Phase 2 study, which met all the primary and secondary efficacy endpoints in the ITT (NYSE:) (Intent-to-treat) and PP (per-protocol) analysis population, demonstrating CBL-514’s statistically and clinically significant efficacy in improving cellulite severity with favorable safety and tolerance profiles.
CBL-514, Caliway’s lead pipeline, is a multi-indication lipolysis injection that can reduce subcutaneous adiposity by inducing adipocyte apoptosis. Among all the current cellulite treatment products, CBL-514 is the first and only product to treat cellulite in the raised areas.
Apart from cellulite treatment, CBL-514 is also under Phase 2 study for subcutaneous fat reduction and Dercum’s disease. Moreover, the U.S. FDA granted CBL-514 Fast Track Designation and Orphan Drug Designation based on the CBL-0201DD Phase 2 study results for Dercum’s disease in February 2024.
CBL-0201EFP Phase 2-stage 1 Topline Results: Significant Reductions in Cellulite Severity Across Three Dosage Groups
CBL-0201EFP Phase 2 study is an open-labeled study to evaluate the safety, tolerability, and efficacy of CBL-514 injection for the treatment of Edematous Fibrosclerotic Panniculopathy (EFP, cellulite). The efficacy was assessed using the modified Hexsel Cellulite Severity Scale (Modified HCSS), with the highest score (9) indicating the most severe cellulite severity and the lowest score (0) indicating no cellulite. The severity level of cellulite will be scored as mild (1-3), moderate (4-6), or severe (7-9), which will be determined by the total scores.
In the CBL-0201EFP Phase 2-stage 1 dose-finding study, a total of 12 participants were enrolled in 3 sequential escalating CBL-514 dose groups, 40mg, 60mg, and 80mg, to receive 1 CBL-514 treatment administered on both sides of the posterolateral thighs.
The statistical analysis revealed significant reductions in cellulite severity across three dosage groups. Follow-up assessments at 2 and 4 weeks post single treatment on both thighs showed statistically significant improvements in cellulite severity for all dosage groups, with the high-dose group of 80 mg showing the most promising efficacy, reducing cellulite severity score (mean ±SD) of -2.0 ±0.9 points (p= 0.00049，95%CI: -2.77, -1.23) and -2.6 ±1.5 (p= 0.00169，95%CI: -3.88, -1.37) at 2 and 4 weeks after treatment.
CBL-0201EFP Phase 2-stage 2 Topline Results: Over 50% of Participants Demonstrated at least One Level of Improvement Among 4 Cellulite Severity Levels
In the CBL-0201EFP Phase 2-stage 2 study is a single-arm study, a total of 23 participants were enrolled to receive up to 2 CBL-514 treatments based on cellulite severity on the thighs, with a maximum single dose not exceeding 320 mg administered at 4-week intervals.
The baseline of participants’ average cellulite severity score (mean ±SD) is 6.5 ± 1.0 points. Four weeks after the final CBL-514 treatment, using Modified HCSS score of 1 ~9 in 4 severity levels, there was a reduction in cellulite severity with a mean change of -1.3 ± 1.3 points (p < 0.00001, 95% CI: -1.70, -0.90), demonstrating CBL-514's statically significant efficacy in cellulite severity improvement at both 4 weeks (p < 0.00001) and 12 weeks (p < 0.00001) after CBL-514 treatment. Moreover, over 50% of participants experienced at least one level of improvement in cellulite severity at the 12 weeks after the final CBL-514 treatment.
In addition to the primary efficacy endpoint, a secondary efficacy endpoint assessed by the Global Aesthetic Improvement Scale (GAIS) demonstrated notable improvements in cellulite. Following the final treatment, both the Principal Investigator (PI) and participants assessed over 95% of individuals as having improved cellulite appearance at the four-week mark.
The safety and tolerability profiles of CBL-514 demonstrated in both stages of the study were favorable and consistent with previous clinical studies of CBL-514. Most adverse events were mild to moderate injection site reactions, including injection site bruising, pain, swelling, and warmth, and were resolved within 28 days post-treatment.
These findings underscore the potential of CBL-514 as a highly effective treatment option for reducing cellulite severity, offering renewed confidence and satisfaction to those affected by this common cosmetic concern.
Following up, Caliway will further develop the cellulite severity scale for future CBL-514 clinical studies to evaluate cellulite improvement efficacy based on the U.S. FDA’s instruction.
About Cellulite (Edematous Fibrosclerotic Panniculopathy, EFP)
Cellulite is characterized by the nonpathological appearance of the dimpled skin surface (likened to orange peel, cottage cheese, or mattress appearance), which occurs on the thighs and buttocks. The relief alterations of cellulite include depressions and raised areas. The depressions are caused by skin retraction by subcutaneous fibrous septa, while raised areas are projections of fat and subcutaneous structures to the skin surface. According to the American Society of Plastic Surgeons (ASPS) report, around 80 to 90% of women experience cellulite dimpling.
The current treatment for cellulite includes non-invasive (medical devices and collagenase drug) and invasive options. However, their efficacy remains limited and temporary. Additionally, most products would cause significant side effects after administration, including severe bruising, pain, and hyperpigmentation, making most patients reluctant to receive them. The clinical need for cellulite treatment remains unmet. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.
About the CBL-0201EFP Phase 2 Study
CBL-0201EFP Phase 2 study is an open-labeled study assessing the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite. The study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2.
The Stage 1 study (clinicaltrial.gov ID: NCT05632926) included a total of 12 participants enrolled in 3 sequential escalating CBL-514 dose groups, 40mg, 60mg, and 80mg. Eligible participants will be sequentially assigned to receive 1 course of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.
The Stage 2 study (clinicaltrial.gov ID: NCT05836779) included a total of 23 participants enrolled in 1 selected CBL-514 dose. Eligible participants will be sequentially assigned to receive up to 2 courses of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.
About CBL-514
CBL-514, a potentially first-in-class small-molecule drug, is a lipolysis injection that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas in animal studies without causing any systematic side effects on the central nervous system and cardiovascular system, and respiratory system. Caliway’s preclinical studies showed that CBL-514 upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio, and then induces dose-dependent adipocyte apoptosis in vivo and in vitro.
Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum’s disease, cellulite, and lipoma treatment.
About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven by the discovery of breakthrough small-molecule therapeutics with a focus on medical aesthetics and inflammatory disease.
Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: http://www.Caliway.com.tw/en
Disclaimer
This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.
For additional contact: info@caliway.com.tw
On Friday, Argus increased its stock price target on Rithm Capital Corp. (NYSE: RITM) to $13.00, up from the previous $12.00, while reaffirming its Buy rating on the stock. The firm highlighted the company’s ongoing transformation and expansion efforts as the rationale behind the revised target price.
Rithm Capital, which rebranded from New Residential Investment Corp. in August 2022, has since transitioned to internal management after previously being managed by Fortress Investment Group. This change is part of a broader transformation of the company’s business model initiated following the financial crisis in late March 2020.
The company has been actively growing its mortgage servicing operations and seizing new debt-related investment opportunities. In its expansion efforts, Rithm Capital has acquired a 50% interest in GreenBarn Investment Group, a commercial real estate equity and debt investment management firm.
Further bolstering its portfolio, Rithm Capital has also made significant acquisitions, including purchasing $1.4 billion worth of Marcus consumer loans from Goldman Sachs for $145 million. Moreover, the company has completed the acquisition of Computershare Mortgage Services Inc. and its affiliates, including Specialized Loan Servicing LLC (SLS), for an approximate total of $720 million.
Completing its notable transactions, Rithm Capital finalized the acquisition of the $33 billion alternative asset manager Sculptor Capital Management (NYSE:) in the fourth quarter of 2023. These strategic moves have contributed to the firm’s positive outlook on Rithm Capital’s stock and its increased price target.
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In light of Argus’s stock recent price target increase for Rithm Capital Corp. (NYSE: RITM), InvestingPro data further supports the optimistic outlook. Rithm Capital’s market capitalization stands at a robust $5.55 billion, while maintaining an attractive P/E ratio of 7.41, indicating that the stock may be undervalued relative to its earnings.
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This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
On Friday, JPMorgan upheld its Overweight rating on CK Infrastructure Holdings (1038:HK) (OTC: CKISY) with a consistent price target of HK$50.00. The firm’s analysis was based on a review of the company’s financial year 2023 results and current operating trends. Adjustments were made to the earnings forecasts for the years 2024 and 2025, with a slight reduction for 2024 by 2% and an increase for 2025 by 2%. These revisions take into account the influence of regulatory changes, inflation, and fluctuating exchange rates on the company’s regulated assets, particularly in the United Kingdom, Australia, and other regions.
The updated model reflects the latest developments and anticipates the potential financial impact on CK Infrastructure. The firm has decided to roll forward its price target to June 2025, while maintaining the previous target of HK$50. The Overweight rating suggests that JPMorgan continues to view the stock favorably in comparison to the sector average.
CK Infrastructure Holdings, which operates a diversified portfolio of infrastructure businesses, has been assessed for its performance and outlook in light of various external factors. The company’s exposure to regulatory resets and economic conditions in different geographies necessitates a nuanced understanding of its earnings potential.
The revised earnings estimates are a direct result of the firm’s comprehensive evaluation of the company’s regulated assets. These assets, which are subject to oversight by regulatory bodies, can be affected by policy changes and economic shifts, such as inflation and currency exchange rates.
JPMorgan’s reaffirmation of the Overweight rating indicates confidence in CK Infrastructure’s ability to navigate the complexities of its operating environment. The price target of HK$50 remains unchanged, signaling the firm’s belief in the company’s value proposition and its prospects for the future.
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This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
On Friday, Argus maintained a Buy rating on Ashland Inc . (NYSE: NYSE:) and increased the stock’s price target to $118 from $109. This adjustment suggests a potential total return of approximately 21%, including dividends, based on the current share prices.
The specialty chemicals and additives provider has experienced underwhelming operational and financial performance over recent quarters, including the second quarter of 2024. This was attributed to slower economic growth in key regions such as China, Europe, and parts of Asia. These areas faced challenges due to soft customer demand and ongoing inventory destocking by suppliers, which adversely affected Ashland’s revenue and profit margins.
Despite these challenges, there have been positive signs in the last quarter indicating a shift in market conditions. Ashland’s management has reported a gradual increase in demand across most of the company’s end markets.
According to Argus, this improvement is a result of the destocking cycle nearing its end and customer demand beginning to rise, which are seen as favorable trends for Ashland’s future growth.
The revised stock price target reflects the analyst’s confidence in Ashland’s recovery trajectory as the market dynamics that previously hindered the company’s performance are starting to reverse. The upward revision in the price target is based on the expectation of a continued recovery in customer demand patterns and the conclusion of inventory destocking.
Investors and market watchers will be monitoring Ashland’s progress closely, as the company aims to capitalize on the improving demand in its various markets and work towards delivering value to its shareholders.
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Key financial metrics include a market capitalization of $4.98 billion, a P/E ratio of 26.25, and a dividend yield of 1.64%. Despite a decline in revenue growth over the last twelve months, the stock has experienced a significant price uptick, with a 29.41% total return over the last six months.
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This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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