AnaMar Scores Big with Positive Phase I Results for Promising Fibrosis Treatment AM1476

AnaMar, a clinical-stage biotech revolutionizing the treatment of systemic sclerosis (SSc), has just announced remarkable results from its Phase I trial with AM1476, their first-in-class, peripheral 5-HT2B receptor antagonist. This groundbreaking medicine has already completed Phase II enabling pre-clinical studies, showing enormous progress towards combating lung and skin fibrosis – two of the most common SSc-related diagnosis. With this success, AnaMar is on the cusp of changing how we treat SSc and its associated symptoms.

In a clinical trial of over 100 healthy participants, AM1476, a highly-selective and potent small molecule delivered as an orally-administered tablet, demonstrated an excellent safety and tolerability profile in all relevant doses – making this treatment a viable option for patients in need!

AM1476 is a promising breakthrough treatment that may be able to halt and reverse the progressive scarring seen in skin fibrosis, a common feature of Systemic Sclerosis (SSc) associated with significant disability, and interstitial lung disease (ILD), a group of conditions that cause fibrosis that can lead to organ dysfunction and even death. This exciting finding gives hope that, for the first time, a treatment may be available to effectively reverse scarring and offer relief to those living with these debilitating conditions.

A Phase II study has been designed to evaluate the treatment effects in SSc-ILD with a proposed dosing regimen for 60 patients in a double-blinded, placebo-controlled randomized trial over 12 months with lung function (forced vital capacity) and skin thickness (modified Rodnan skin score) as primary efficacy readouts. Active product ingredients are being made ready as cGMP materials for this Phase II trial.

The company is planning regulatory submissions, in 2023, to the FDA and EMA for Orphan Drug Designation for the rare disease SSc. Drawing on its heritage in diagnostics, the company is also developing biomarkers and gene signatures to identify patients most likely to respond to treatment and ensure the best outcomes for patients with fibrosis.

Dr. Ulf Ljungberg, CEO of AnaMar, is delighted to announce the development of their Phase II ready compound AM1476 to treat the rare orphan disease, systemic sclerosis. This 5-HT2B receptor antagonist has shown immense potential in pre-clinical and Phase I studies, bringing the promise of a medicine to prevent, heal and slow organ scarring for fibrosis sufferers.

AnaMar holds a wide, patent-protected, portfolio of selective and high affinity 5-HT2B receptor antagonists and they look forward to partnering with a pharmaceutical organization in bringing new hope to fibrotic patients.

Dr. Christina Wenglén, Head of Research at AnaMar, has highlighted the pressing unmet need for a dual-action approach to treat skin and lung manifestations of systemic sclerosis, such as ILD and skin fibrosis which are often progressive and have a poor prognosis.

AM1476 is poised to address this need as it represses both macrophage and fibroblast activity. Therefore, AnaMar is strongly committed to pushing this novel therapeutic into clinical practice.

AM1476 has been shown to be a powerful anti-fibrotic agent in several preclinical, state-of-the-art animal models of fibrosis. Remarkably, the progress of already established fibrosis in skin and lung tissue was effectively halted and even reversed when the animals were treated with AM1476, underlining its promising efficacy in fighting this condition.

Unlock the Secrets of AnaMar: Discover Its Incredible History!

Based in Lund, Sweden, AnaMar is developing a first-in-class, anti-fibrotic medicine to prevent, slow and heal scarring caused by fibrosis through its patented suite of serotonin (5-HT2B) receptor antagonists.

AM1476, our selective, oral 5-HT2B receptor antagonist, is a game changer when it comes to treating fibrotic conditions which adversely affect millions of people and lack treatment options. This revolutionary drug has succeeded in four different models so far: in vitro and in vivo models of fibrosis, and favourable safety and pharmacokinetic profiles in Phase I clinical studies. Most significantly, its dual-action treatment offers an unprecedented solution for skin and lung related complications of systemic sclerosis.

By targeting peripheral 5-HT2B receptors, our antagonists provide a revolutionary solution to addressing fibrosis. Instead of relying on drugs which may cause unwanted side-effects or drug interactions, these antagonists can greatly reduce 5-HT-induced myofibroblast and macrophage activity, and even TGF-β production, bringing much-needed relief to patients.

We’re unlocking the power of cutting-edge therapeutics and advanced diagnostics to deliver the best possible outcomes for those suffering from fibrosis. Our unique platform combines biomarkers and genetics analysis to pinpoint which patients are the most likely to benefit from treatment, enabling us to provide superior care and results.

We are actively looking for partnerships with pharmaceutical companies to propel AM1476 into Phase II clinical trials. Our internal IP includes a comprehensive library of profiled compounds that could be of use to prospective collaborators. Let us help you take your research to the next level and leap forward in the medical advancements of tomorrow.

AnaMar’s expert leadership team is leading the charge towards groundbreaking new medicines, having received significant backing from the Allegro Investment Fund to further their research and development. With years of success under their belt, AnaMar is forging a path towards an innovative future.

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