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Timber Pharmaceuticals Inc., a LEO Pharma company, today announced the results for the randomized, double-blind 12-week period of the ASCEND trial. The trial did not show a statistically significant difference between the proportion of patients treated with TMB-001 responding to treatment after 12 weeks compared with patients treated with vehicle..

利奥制药公司Timber Pharmaceuticals Inc.今天宣布了ASCEND试验随机、双盲12周的结果。。。

ASCEND is the phase 3 clinical trial of TMB-001, an investigational topical ointment formulation of isotretinoin for the potential treatment of patients with moderate to severe congenital ichthyosis. The trial evaluated the efficacy and safety of TMB-001 in the treatment of congenital ichthyosis in patients (aged 6 years or older) with either the autosomal recessive congenital ichthyosis (ARCI) or X-linked recessive ichthyosis (XLRI) subtypes..

ASCEND是TMB-001的3期临床试验，TMB-001是一种异维A酸的研究性局部软膏制剂，可用于治疗中度至重度先天性鱼鳞病患者。该试验评估了TMB-001治疗常染色体隐性先天性鱼鳞病（ARCI）或X连锁隐性鱼鳞病（XLRI）亚型患者（6岁或以上）先天性鱼鳞病的疗效和安全性。。

LEO Pharma acquired TMB-001 from Timber Pharmaceuticals in January 2024 following Timber’s Chapter 11 bankruptcy filing. Timber Pharmaceuticals was a clinical-stage biopharmaceutical rare disease dermatology company focused on the development of treatments for rare and orphan dermatologic diseases, and TMB-001 had received orphan, fast-track, and break-through designation by the FDA.

利奥制药（LEO Pharma）于2024年1月从木材制药公司（Timber Pharmaceuticals）收购了TMB-001，此前木材公司已提交第11章破产申请。Timber Pharmaceuticals是一家临床阶段的生物制药罕见病皮肤病公司，专注于开发罕见和孤儿皮肤病的治疗方法，TMB-001已获得FDA的孤儿，快速通道和突破性指定。

As a consequence of the acquisition, Timber Pharmaceuticals was reformed as a fully owned subsidiary of LEO Pharma..

收购的结果是，Timber Pharmaceuticals被改造为LEO Pharma的全资子公司。。

“There are currently no topical treatments specifically developed and approved for the treatment of congenital ichthyosis in the United States, making it a challenging disease to treat. We are disappointed and saddened by the results of the phase 3 trial. After encouraging phase 2b results, we observed an unexpectedly high vehicle response in this trial.

“目前，美国还没有专门开发和批准用于治疗先天性鱼鳞病的局部治疗方法，这使其成为一种具有挑战性的疾病。我们对3期试验的结果感到失望和悲伤。在鼓励2b期结果后，我们在该试验中观察到出乎意料的高载体反应。

We had hoped that TMB-001 could have been a new potential treatment to help children and adults suffering from moderate to severe congenital ichthyosis and to allow them to live a quality life they had previously not known,” said John Koconis, Chief Executive Officer of Timber Pharmaceuticals..

我们曾希望TMB-001能够成为一种新的潜在治疗方法，帮助患有中度至重度先天性鱼鳞病的儿童和成年人，并让他们过上以前不知道的优质生活，”木材制药首席执行官约翰·科科尼斯（JohnKoconis）说。。

Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma added: 'LEO Pharma remains fully committed to innovative research in dermatologic diseases with a high unmet need as we strive to make a difference for people living with skin diseases and their families. This means investing in trials to explore potential new treatments that can address the high unmet need these people face every day.

LEO Pharma首席开发官Kreesten Meldgaard Madsen补充道：“LEO Pharma仍然全力致力于皮肤病的创新研究，因为我们努力为皮肤病患者及其家人带来改变。这意味着投资于试验，探索潜在的新疗法，以解决这些人每天面临的高度未满足的需求。

Unfortunately, as is the case for all pharmaceutical research, not all trials are successful.”.

不幸的是，正如所有药物研究的情况一样，并非所有的试验都是成功的。”。

The results of the analysis will not have material impact on the 2024 financial results for the LEO Pharma group.

分析结果不会对利奥制药集团2024年的财务业绩产生重大影响。

Detailed results from ASCEND are planned to be submitted for scientific publication at a later date.

ASCEND的详细结果计划稍后提交科学出版物。

About ASCEND

ASCEND is the pivotal phase 3 clinical trial of TMB-001, an investigational topical ointment formulation of isotretinoin for the potential treatment of patients with moderate to severe congenital ichthyosis. The trial program represents the first vehicle-controlled Phase 3 trial program of any topical retinoid in this condition.

ASCEND是TMB-001的关键3期临床试验，TMB-001是一种异维A酸的研究性局部软膏制剂，可用于治疗中度至重度先天性鱼鳞病患者。该试验计划代表了在这种情况下任何局部类维生素A的第一个车辆控制的3期试验计划。

The phase 3 trial evaluated the efficacy and safety of TMB-001 in the treatment of congenital ichthyosis in patients aged ≥6 years with either the autosomal recessive congenital ichthyosis (ARCI) or X-linked recessive ichthyosis (XLRI) subtypes. For more information on the ASCEND trial (NCT05295732) go to clinicaltrials.gov..

3期试验评估了TMB-001治疗常染色体隐性先天性鱼鳞病（ARCI）或X连锁隐性鱼鳞病（XLRI）亚型≥6岁患者先天性鱼鳞病的疗效和安全性。有关ASCEND试验（NCT05295732）的更多信息，请访问clinicaltrials.gov。。

About LEO Pharma

关于LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities.

利奥制药（LEO Pharma）是一家全球性公司，致力于提高护理标准，造福皮肤病患者及其家人和社会。LEO Pharma成立于1908年，由LEO基金会拥有多数股权。LEO Pharma致力于数十年的研究和开发，以推动皮肤病学的发展。如今，该公司为所有严重疾病提供了广泛的治疗方法。

LEO Pharma is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. For more information, please visit www.leo-pharma.com..

利奥制药（LEO Pharma）总部位于丹麦，拥有4200人的全球团队，为全球数百万患者提供服务。2023年，该公司净销售额为114亿丹麦克朗。欲了解更多信息，请访问www.leo-pharma.com。。