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• The Nature Reviews Drug Discovery article describes the current state of ALS drug development for both preclinical and clinical stages, as well as examples of translational science including for Aclipse’s M102 candidate.
• M102 is in preclinical development for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.
• M102 development is financially supported by the United States Department of Defense, the United Kingdom’s Medical Research Council, and Australia’s FightMND.

Radnor, PA, USA – January 2, 2023 – Aclipse Therapeutics, and its subsidiary Aclipse One, Inc (“Aclipse” or “the Company”), an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases, announced today that Nature Reviews Drug Discovery published on December 21, 2022 in Volume 22, Issue 12 a review article entitled Amyotrophic Lateral Sclerosis: a neurodegenerative disorder poised for successful therapeutic translation with authors Richard J. Mead, Ning Shan, H. Joseph Reiser, Fiona Marshall, and Pamela J. Shaw.  Authors from both the Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield, United Kingdom and Aclipse review the current state of ALS drug development and provide examples of translation for several drug candidates, including for Aclipse’s M102 candidate.

M102 is in late-stage IND-enabling studies for the treatment of amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease. M102 takes a dual mechanism approach with M102 activating both the Nrf2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways, which are understood to impact ALS pathophysiology. The Company is taking a targeted, precision approach to the development of M102 by identifying genetic markers of potential ALS drug responders. Industry data indicate that a precision medicine approach may increase the probability of clinical success by 2- to 3-fold.   

Aclipse licensed M102 from SITraN and is developing M102 along with SITraN collaborators Professor Dame Pamela Shaw, Professor Laura Ferraiuolo, and Dr. Richard Mead. M102 development has been supported by research grants from the United States Department of Defense, the United Kingdom’s Medical Research Council, and Australia’s FightMND.

“The publication of this Nature Reviews Drug Discovery article is an important step in the collaboration between SITraN and Aclipse to develop M102 for use in ALS patients who are in urgent need of effective therapies. Based on preclinical results to date, M102 may be mechanistically superior to currently approved ALS drugs and may lead to significant slowing of disease progression in patients with ALS with potential impact in other neurodegenerative diseases such as Fredrich ataxia and Parkinson’s disease,”
stated Ning Shan, PhD., Chief Scientific Officer of Aclipse Therapeutics and co-author of the Nature Reviews Drug Discovery article.

About ALS/MND

Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects motor neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. Based on population studies, as many as 25,000 Americans have ALS at any given time.

About Aclipse Therapeutics

Aclipse Therapeutics is an innovative biopharmaceutical company that develops novel and differentiated drugs to treat diseases with significant unmet medical needs. M102 is a dual Nrf2/HSF1 activator for the treatment of ALS and other neurodegenerative diseases. M102 uses a precision medicine approach to identify those ALS patients who are most likely to benefit from the drug.  Aclipse has an experienced drug development team and a clinical advisory board of key opinion leaders in ALS.  For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

Contact:

Raymond K. Houck
rhouck@aclipsetherapeutics.com
+1-412-606-7214

• The US Patent and Trademark Office’s patent issuance marks the first patent issuance to Aclipse for M102’s four patent families.
• M102 is in preclinical development for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.
• M102 is financially supported by the United States Department of Defense, the United Kingdom’s Medical Research Council, and Australia’s FightMND.

Radnor, PA, USA – November 10, 2022 – Aclipse Therapeutics, and its subsidiary Aclipse One, Inc (“Aclipse” or “the Company”), an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases, announced today that the U.S. Patent and Trademark Office (USPTO) has issued patent no. 11,459,301 entitled, “Crystalline Form of S-Apomorphine”. The patent protects the composition-of-matter of the Company’s M102 drug candidate as well as the related methods of use, with expected patent protection to at least 2039.

Aclipse is conducting IND-enabling studies for M102 for the treatment of amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease. M102 takes a dual mechanism approach to the treatment of ALS with M102 activating both the Nrf2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways. The Company is taking a targeted, precision approach to the development of M102 by identifying genetic markers of potential ALS drug responders. Industry data indicates that a precision medicine approach increases the probability of clinical success by 2- to 3-fold.

Aclipse licensed M102 from the Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield, United Kingdom and is developing M102 with Professor Dame Pamela Shaw, MD and her team at SITraN with support from the United Kingdom’s Medical Research Council, Australia’s FightMND, and the United States Department of Defense through its U.S. Army Medical Research and Development Command.

“This patent issuance is an important step in the development of M102 for use in ALS patients who are in urgent need of effective therapies. Based on preclinical results to date, M102 may be mechanistically superior to currently approved ALS drugs and may lead to significant slowing of disease progression in patients with ALS with potential impact in other neurodegenerative diseases,”
stated Raymond K. Houck, Chief Executive Officer of Aclipse Therapeutics.

About ALS/MND
Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects motor neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. Based on population studies, as many as 25,000 Americans have ALS at any given time.

About Aclipse Therapeutics
Aclipse Therapeutics is an innovative biopharmaceutical company that develops novel and differentiated drugs to treat diseases with significant unmet medical needs. M102 is a dual Nrf2/HSF1 activator for the treatment of ALS and other neurodegenerative diseases. M102 uses a precision medicine approach to identify those ALS patients who are most likely to benefit from the drug. Aclipse has an experienced drug development team and a clinical advisory board of key opinion leaders in ALS. For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

Contact:
Raymond K. Houck
rhouck@aclipsetherapeutics.com
+1-412-606-7214

FDA supports the initiation of Aclipse Therapeutics’ Phase 2 development of M107
for Idiopathic Gastropareses

Radnor, PA, USA – July 18, 2022 – Aclipse Therapeutics and its subsidiary Aclipse Two Inc (“Aclipse” or “the Company”), an innovative biopharmaceutical company developing life-changing treatments for patients with severe diseases, today announced that the Company has received feedback from the US Food and Drug Administration (“FDA”) in a pre-Investigational New Drug (“pre-IND”) meeting. The FDA stated that pending review of the IND the Company’s nonclinical and clinical study package appears to be adequate to support the initiation of the Company’s proposed phase 2 dose-ranging efficacy study titled, “Randomized Double-blind Placebo Controlled Study of M107 for the Treatment of Idiopathic Gastroparesis”. The Company plans to submit extensive ex-US clinical experience in support of the IND. In addition, the FDA provided various comments and suggestions on the Company’s plans for phase 2 and 3 clinical designs, primary and secondary endpoints, safety database, as well as chemical, manufacturing and controls (“CMC”) development.

M107 is the first potential disease-modifying drug candidate for the treatment of gastroparesis, a chronic and serious gastrointestinal disease affecting stomach nerves and muscles resulting in stomach paralysis and delayed stomach emptying. M107 seeks to treat the underlying pathology of gastroparesis by switching human pro-inflammatory M1 macrophages to anti-inflammatory M2 macrophages. M107 lowers inflammation in the stomach and increases the population of the interstitial cells of Cajal (i.e., the pacemaker cells of the stomach), allowing for increased stomach emptying and function and decreased fibrosis of the stomach pylorus.

Gastroparesis affects approximately 600,000 patients in the US and similar numbers in the EU. Gastroparesis patients with severe disease have frequent hospitalizations and limited treatment options. Both current FDA-approved drugs and existing clinical-stage drug candidates for gastroparesis target only the symptoms of the disease. Approximately half of gastroparesis patients suffer from idiopathic disease, indicating that their disease is due to unknown causes, while most of the remaining patients have underlying diabetes.

“I am thrilled with the FDA response to Aclipse’s proposed phase 2 dose-ranging clinical trial plan and the path to initiate our M107 human trial. We can now move forward to completing phase 2 manufacturing for the clinical supply and filing of the M107 IND submission to FDA.”
said Raymond K. Houck, Chief Executive Officer of Aclipse Therapeutics.

About Aclipse Therapeutics
Aclipse Therapeutics is an innovative biopharmaceutical company that develops novel and differentiated drugs to treat diseases with significant unmet medical needs. Aclipse has two programs M107, a potential first disease-modifying agent for the treatment of gastroparesis, and M102, a dual Nrf2/HSF1 activator, and a potential first targeted medicine for the treatment of sporadic amyotrophic lateral sclerosis (ALS) patients. M102 uses a precision medicine approach to identify those ALS patients who are most likely to benefit from the drug. Aclipse has an experienced drug development team and a clinical advisory board of key opinion leaders in its respective diseases. For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

Contact:
Raymond K. Houck
rhouck@aclipsetherapeutics.com
+1-412-606-7214