Latest news with #IFN
Yahoo
29-05-2025
- Business
- Yahoo
Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis
-Topline readout expected in early Q1 2026- SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. "We are excited to announce the completion of patient enrollment in our pivotal Phase 3 ONWARD clinical program evaluating ESK-001 for moderate-to-severe plaque psoriasis,' said Martin Babler, President and Chief Executive Officer of Alumis. 'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need." 'As we advance the development of ESK-001, we recognize the ongoing challenges patients with plaque psoriasis face in finding effective and convenient treatment options," said Dr. Jörn Drappa, Alumis' Chief Medical Officer. "Many patients cycle through therapies due to the inconvenience of injectable biologics and the diminishing effectiveness of oral treatments. With its differentiated profile, ESK-001 has the potential to provide a well-tolerated oral TYK2 inhibitor that delivers durable, biologic-like clinical responses, bridging a critical gap in treatment." The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. ONWARD 3, an optional long-term extension trial for patients who have completed Week 24, is currently ongoing to assess the durability, maintenance of response, and long-term safety of ESK-001. About ESK-001 Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis are currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738). Over 1,700 patients were enrolled across the two trials and randomized 2:1:1 to receive ESK-001 40 mg twice-daily, placebo or apremilast. The co-primary efficacy endpoints will be the proportion of patients with moderate-to-severe plaque psoriasis achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and sPGA score 0/1 of ESK-001 compared to placebo at Week 16. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial (NCT05600036), and by the long-term open-label extension (CT05739435) which is currently ongoing. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 designed to replace the current immediate-release oral formulation that is dosed twice daily. ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001's potential application in other immune-mediated conditions. About AlumisAlumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit or follow us on LinkedIn or X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of federal securities laws, including the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readout in its ONWARD Phase 3 program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis' future plans and prospects including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis' clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities and achieve development goals, Alumis' ability to protect its intellectual property and other risks and uncertainties described in Alumis' filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. CONTACT: Alumis Contact Information Teri Dahlman Red House Communications teri@
Associated Press
29-05-2025
- Business
- Associated Press
Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis
SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. 'We are excited to announce the completion of patient enrollment in our pivotal Phase 3 ONWARD clinical program evaluating ESK-001 for moderate-to-severe plaque psoriasis,' said Martin Babler, President and Chief Executive Officer of Alumis. 'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need.' 'As we advance the development of ESK-001, we recognize the ongoing challenges patients with plaque psoriasis face in finding effective and convenient treatment options,' said Dr. Jörn Drappa, Alumis' Chief Medical Officer. 'Many patients cycle through therapies due to the inconvenience of injectable biologics and the diminishing effectiveness of oral treatments. With its differentiated profile, ESK-001 has the potential to provide a well-tolerated oral TYK2 inhibitor that delivers durable, biologic-like clinical responses, bridging a critical gap in treatment.' The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. ONWARD 3, an optional long-term extension trial for patients who have completed Week 24, is currently ongoing to assess the durability, maintenance of response, and long-term safety of ESK-001. About ESK-001 Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis are currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 ( NCT06586112 ) and ONWARD2 ( NCT06588738 ). Over 1,700 patients were enrolled across the two trials and randomized 2:1:1 to receive ESK-001 40 mg twice-daily, placebo or apremilast. The co-primary efficacy endpoints will be the proportion of patients with moderate-to-severe plaque psoriasis achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and sPGA score 0/1 of ESK-001 compared to placebo at Week 16. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial (NCT05600036), and by the long-term open-label extension (CT05739435) which is currently ongoing. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 designed to replace the current immediate-release oral formulation that is dosed twice daily. ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001's potential application in other immune-mediated conditions. About Alumis Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readout in its ONWARD Phase 3 program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis' future plans and prospects including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis' clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities and achieve development goals, Alumis' ability to protect its intellectual property and other risks and uncertainties described in Alumis' filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Alumis Contact Information Teri Dahlman Red House Communications [email protected]
Daily Tribune
05-03-2025
- Business
- Daily Tribune
Al Baraka Group banking units win over 10 IFN awards for outstanding services
Al Baraka Group announces that four of its banking units have won over 10 awards at the recent Islamic Finance News (IFN) Awards ceremony held in Dubai. Al Baraka Bank Egypt was recognized as the Best Islamic Retail Bank and Best Digital Offering in Egypt. Al Baraka Bank South Africa received the awards of Best Islamic Bank in South Africa and Best Islamic Corporate & Retail Bank. Al Baraka Bank Tunisia was honored as the Best Islamic Bank in Tunisia, Best Islamic Corporate & Retail Bank, in addition to being recognized for Most Innovative Offering and Best Digital Offering. Furthermore, Jordan Islamic Bank was awarded as the Best Islamic Bank in Jordan, Best Islamic Investment & Retail Bank, and Most Innovative Islamic Bank in Jordan. This achievement reflects Al Baraka Group's commitment to providing world-class Sharia-compliant financial solutions. Winning these prestigious awards in a single year further strengthens the Group's position in the Islamic banking sector and highlights the trust of its customers and stakeholders, as the winners are selected through an extensive industry-wide voting process. Mr. Houssem Ben Haj Amor, Board Member and Group CEO of Al Baraka Group, stated:'This achievement aligns with our ongoing mission to provide ethical, customer-centric financial services that adhere to Sharia principles. Through our banking units, we continue to innovate and enhance digital offerings to promote financial inclusion, support economic growth, and uphold the highest standards of Islamic banking. As we celebrate this recognition, we extend our sincere gratitude to our banking units, customers, employees, and partners, reaffirming our commitment to excellence'. The IFN Awards are among the most prestigious in the global Islamic finance industry, recognizing institutions that demonstrate outstanding performance and make a tangible impact in their markets. Winners are selected through an industry-wide voting process, reflecting the confidence and trust of customers and stakeholders in the awarded banks.'
Zawya
04-03-2025
- Business
- Zawya
Bank Nizwa's focus on excellence, innovation, and social responsibility earns top honours at IFN Awards
Muscat: Once again demonstrating its industry preeminence, Bank Nizwa, the leading and most trusted Islamic bank in the Sultanate of Oman, recently secured multiple accolades at the prestigious Islamic Finance News (IFN) Awards 2024, held in Dubai. The bank was honoured with the 'Best Islamic Bank in Oman' award and the 'Best Islamic Retail Bank in Oman' award, while also earning three landmark deal-based awards— 'IFN Ijarah Deal of the Year 2024', 'IFN Oman Deal of the Year 2024', and 'IFN Social Impact Deal of the Year 2024'. These honours underscore Bank Nizwa's unwavering dedication to people-centricity, financial ingenuity, and transformative impact in the Islamic finance sector. Commenting on the wins, Mr. Khaled Al Kayed, Chief Executive Officer at Bank Nizwa, said, 'These accolades are a testament to our relentless pursuit of excellence and our commitment to redefining Islamic finance as a driver of economic progress and social prosperity. At Bank Nizwa, we measure success not just by financial milestones but by the enduring value we create—whether in delivering exceptional banking solutions, expanding access to Sharia-compliant financial services, or advancing Oman's broader development agenda. Our commitment to responsible innovation, market leadership, and long-term value creation will continue to shape the future of Islamic finance, strengthening its role as a catalyst for inclusive and sustainable growth.' Bank Nizwa's recognition as the 'Best Islamic Bank' and 'Best Islamic Retail Bank in Oman' reaffirms its leadership in driving the growth of Islamic finance. The bank's ability to navigate an evolving financial landscape while delivering superior, Sharia-compliant solutions has set new standards for operational excellence, financial strength, and customer focus. By continuously expanding its portfolio through digital innovation and personalized financial offerings, Bank Nizwa remains at the forefront of retail banking, empowering individuals with transparent and accessible financial solutions tailored to their evolving needs. Bank Nizwa's expertise in structuring sophisticated financial transactions was exemplified in its role as Joint Lead Manager and Bookrunner for Omantel's US$500 million Sukuk issuance, a landmark deal that earned the bank both the 'IFN Ijarah Deal of the Year 2024' and the 'IFN Oman Deal of the Year 2024'. This transaction not only strengthened Oman's Islamic capital market but also set a benchmark for corporate Sukuk issuances. Reflecting its commitment to social responsibility, Bank Nizwa was also honoured with the 'IFN Social Impact Deal of the Year 2024'. As a key sponsor of the Ishraq Waqf Investment Fund, launched in collaboration with the Ministry of Endowments and Religious Affairs, the Sultan Qaboos Higher Center for Culture and Science, and Oman National Investments Development Company (TANMIA), the bank played a pivotal role – as the Issuing Manager and Collecting Bank – in establishing a sustainable and Sharia-compliant investment framework for Oman's waqf sector. By directing structured waqf investments into charitable and community-driven initiatives, the fund reinforces the bank's keen emphasis on integrating Islamic finance with ESG-driven strategies. These recognitions at the IFN Awards are a testament to Bank Nizwa's strong leadership, ability to drive meaningful innovation, and its commitment to fostering a resilient and values-driven financial ecosystem. The bank remains at the forefront of shaping Oman's Islamic banking landscape, delivering sustainable solutions that drive both economic prosperity and social impact.
Zawya
25-02-2025
- Business
- Zawya
Islamic Corporation for the Insurance of Investment and Export Credit's (ICIEC) supported Highway and Road Program in Senegal Wins Two Islamic Finance News (IFN) Awards 2024
The Islamic Corporation for the Insurance of Investment and Export Credit (ICIEC) ( a Shariah-compliant multilateral insurer and member of the Islamic Development Bank (IsDB) Group, is pleased to announce that a Highway Project in Senegal, supported by ICIEC, has been recognized with two prestigious Islamic Finance News (IFN) Awards 2024: IFN Sovereign&Multilateral Deal of the Year 2024 – Republic of Senegal EUR Tawarruq Financing IFN Africa Deal of the Year 2024 – Republic of Senegal's EUR Tawarruq Financing The awards acknowledge ICIEC's crucial role as the Guarantor of Islamic Finance Tranche for the landmark EUR 259 million Murabaha facility extended by Société Générale. The facility, provided under ICIEC's Non-Honouring of a Sovereign Financial Obligation (NHSFO) insurance policy, supports the construction of key road projects in Senegal, including the Dakar-Tivaouane Highway and the expansion of the Cyrnos-Seven Up Road. This Takaful cover agreement demonstrates ICIEC's commitment to facilitating impactful infrastructure projects that bolster economic growth, regional connectivity, and sustainable development. By significantly reducing travel times, cutting carbon emissions, and streamlining the movement of goods, these road projects will elevate Senegal's transport infrastructure and enhance the quality of life for local communities. Moreover, they are expected to generate substantial employment opportunities both during construction and in the long term. Commenting on the recognition, Dr. Khalid Khalafalla, CEO of ICIEC said:'We are honored that the Highway and Road Project in Senegal has received these two distinguished IFN awards. This acknowledgment reaffirms ICIEC's commitment to delivering Shariah-compliant risk mitigation solutions that spur economic transformation and resilience in our member states. It also underscores the power of strategic partnerships in fostering sustainable development and improving lives.' As part of its mandate, ICIEC continues to serve as a catalyst for socioeconomic progress in the Organization of Islamic Cooperation (OIC) countries. By leveraging innovative insurance and credit enhancement tools, ICIEC remains dedicated to supporting member states in their journeys toward prosperity and well-being. Distributed by APO Group on behalf of Islamic Corporation for the Insurance of Investment and Export Credit (ICIEC). Media Contact: Rania Binhimd, Strategic Planning and Communications Division Email: Rbinhimd@ Follow us on: X: Facebook: LinkedIn: YouTube: Instagram: For more information, visit: About The Islamic Corporation for the Insurance of Investment and Export Credit (ICIEC): ICIEC commenced operations in 1994 to strengthen economic relations between OIC Member States and promote intra-OIC trade and investments by providing risk mitigation tools and financial solutions. The Corporation is uniquely the only Islamic multilateral insurer in the world. It has led from the front in delivering a comprehensive suite of solutions to companies and parties in its 50 Member States. ICIEC, for the 17 th consecutive year, maintained an "Aa3" insurance financial strength credit rating from Moody's, ranking the Corporation among the top of the Credit and Political Risk Insurance (CPRI) Industry. Additionally, ICIEC has been assigned a First-Time 'AA-' long-term Issuer Credit Rating by S&P with Stable Outlook. ICIEC's resilience is underpinned by its sound underwriting, reinsurance, and risk management policies. Cumulatively, ICIEC has insured more than USD 121 billion in trade and investment. ICIEC activities are directed to several sectors - energy, manufacturing, infrastructure, healthcare, and agriculture.
