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Aelis Farma Announces Positive Results From Its Safety Trials in Healthy Volunteers and the Authorization to Start the First Trial in People with Down Syndrome with AEF0217, its Drug Candidate for the Treatment of Cognitive Disorders

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  • AEF0217 is being developed as the first treatment for cognitive deficits caused by a hyperactivity of the CB1 receptor, the first indication being those linked to Down syndrome (Trisomy 21), which is currently a major unmet medical need.
  • The single dose and multiple ascending dose trial of AEF0217 has demonstrated the safety, tolerability and good bioavailability of AEF0217 in healthy volunteers.
  • On the basis of these positive results, the AEMPS, the Spanish agency for medicines and medical devices, has authorized a phase 1/2 clinical trial in adults with Trisomy 21. This study will test the safety, tolerability and plasma exposure and may provide preliminary indications of AEF0217’s activity.
  • Enrollment in the phase 1/2 clinical trial is expected to start before the end of the year.

BORDEAUX, France–(BUSINESS WIRE)–Regulatory News:

Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS, PEA-PME eligible) (Paris: AELIS), a clinical stage biopharmaceutical company specializing in the development of treatments for brain diseases, announces today positive results from its phase 1 clinical trials in healthy volunteers with its drug candidate AEF0217. AEF0217 is being developed for the treatment of cognitive deficits caused by a hyperactivity of the CB1 receptor, and as a first indication those associated with Trisomy 21 (Down syndrome). Acute and chronic administration of AEF0217, up to 30 times the anticipated therapeutic range, is well tolerated and presents favorable safety and plasma exposure profiles, which allow the next stage of clinical development.

AEF0217 is the second drug candidate of the new class of drugs developed by Aelis Farma: the Signaling Specific inhibitors of the CB1 receptor (CB1-SSi). The CB1 is the main receptor of the brain’s endocannabinoid system that is responsible for regulating several physiological and cognitive processes. Recent research has suggested that cognitive disorders linked to Trisomy 21 involve a hyperactivity of the CB1 receptor. AEF0217 is positioned as the first treatment for cognitive deficits caused by hyperactivity of the CB1 receptor. AEF0217 aims to capitalize on the distinctive characteristics of CB1-SSi which allow to inhibit a hyperactivity of the CB1 receptor without affecting normal physiological functions and without causing significant side effects, two criteria that are particularly important for vulnerable populations such as those with Down syndrome.

Pier Vincenzo Piazza, CEO of Aelis Farma, commented: “The very positive results of the phase 1 program achieved with AEF0217 constitute a significant step in the development of this drug candidate to treat cognitive deficits and in particular those linked to Trisomy 21, also known as Down syndrome. They also confirm the strong potential of the therapeutic class developed by Aelis Farma, the CB1-SSi, showing again an excellent safety profile as well as favorable pharmacokinetic characteristics. AEF0217 can now move forward and enter a phase 1/2 trial in people with Trisomy 21. This significant progress enables us to swiftly move towards the confirmation of AEF0217’s therapeutic potential to improve the cognitive deficits of people with Trisomy 21, for which there are no effective therapeutic solutions today.”

The phase 1 clinical program of AEF0217 combines three clinical trials authorized by the Spanish health authority, the AEMPS, in September 2021: a single ascending doses trial, a multiple (7 days) ascending doses trial, and a pharmacokinetic trial analyzing the impact of food consumption on drug absorption. This overall clinical program was designed to assess the safety, tolerability and absorption of AEF0217, in the range between 0.2 mg and 6 mg, in comparison with a placebo, in 68 healthy volunteers, aged between 18 and 55 years old.

The results obtained have shown that all the doses of AEF0217 were well tolerated by healthy volunteers with no serious adverse reaction. Only 3 adverse events related to AEF0217, manifesting as low intensity diarrhea, were observed during the full program. In addition, no relevant clinical changes in routine biological tests, electrocardiograms or vital signs were observed. Similarly, psychometric tests assessing main psychological dimensions, such as depression, anxiety, psychosis and suicidal tendencies did not show significant difference between AEF0217 and placebo. The pharmacokinetic profile of AEF0117 has also proven favorable and, as expected, is characterized by very good plasma absorption, linearity between doses and a long half-life.

“These positive results for AEF0217 are all the more encouraging as the safety of the compound is a particularly important criterion for the treatment of the Down syndrome population and for acceptance by the families of a treatment for cognitive deficits for these vulnerable people. We are delighted to be part of this revolutionary and exciting project to assess this drug candidate, which represents real hope for many people affected by Down syndrome and their families,” added Prof. Rafael de la Torre Fornell, principal investigator of the clinical trials and coordinator of the ICOD project.

It is thanks to these positive data that the AEMPS has authorized the advancement of AEF0217 to a first clinical trial in participants with Down syndrome. The main objective of this phase 1/2 study will be to demonstrate the safety, tolerability and the pharmacokinetic profile of AEF0217 in people with Down syndrome. The trial could also provide initial evidence of the activity of this drug candidate. The first enrollments are expected before the end of 2022 and the first clinical results should be available in mid-2023.

***

About the clinical program of AEF0217 for the treatment of cognitive disorders in Trisomy 21: Europe’s ICOD project.

The phase 1 program of AEF0217 is part of the European H2020 ICOD project (Improving COgnition in Down syndrome, Grant N° 899986), and is being performed in collaboration with the Hospital del Mar Medical Research Institute (IMIM) in Barcelona (Spain) and Prof. Rafael de la Torre Fornell, coordinator of the project and principal investigator of the trial. In February 2021, the ICOD project received funding of €6 million from the European Commission in order to finance the clinical development of AEF0217 for the treatment of cognitive deficits linked to Down syndrome.

About AELIS FARMA

Founded in 2013, Aelis Farma is a biopharmaceutical company that is developing a new class of drugs, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). These new molecular entities hold great potential in the treatment of many brain diseases. CB1-SSi were developed by Aelis Farma on the basis of the discovery of a new natural defense mechanism of the brain made by the team of Dr. Pier Vincenzo Piazza, CEO of the Company, when he was Director of the Magendie Neurocenter of Inserm in Bordeaux. For these discoveries, Dr. Piazza was awarded the Inserm Grand Prix and the Grand Prix of Neurology of the French Academy of Sciences, which are among the most prestigious French awards in medicine and neurology.

Aelis Farma is developing two first-in-class drug candidates that are at the clinical stage, AEF0117 and AEF0217, and has a portfolio of innovative CB1-SSi for the treatment of other diseases associated with a dysregulation of the activity of the CB1 receptor.

AEF0117, which targets disorders due to excessive cannabis use (addiction and psychosis), has shown indications of efficacy in a phase 2a clinical trial and entered a phase 2b clinical trial in the United States in Q2 2022. Aelis Farma has an exclusive option-license agreement with Indivior PLC, a leading pharmaceutical company in the treatment of addiction, for the development and commercialization of AEF0117 for disorders due to excessive cannabis use. As part of this agreement, Aelis Farma has already received $30 million (option payment). If Indivior exercises the license option at the end of the phase 2b, Aelis Farma will receive a $100 million license fee (potentially in 2024) and Indivior will take responsibility for additional development costs. The agreement also includes up to $340 million in additional payments contingent on the achievement of development, regulatory and commercial milestones, as well as royalties on net sales of AEF0117 ranging between 12% and 20%.

AEF0217, which targets various cognitive disorders including those associated with Down syndrome, has successfully completed safety and pharmacokinetic trials (phase 1 clinical program) in healthy volunteers and will enter phase 1/2 trials before the end of 2022. This new trial will assess the safety and the pharmacokinetics of AEF0217 in people with Down syndrome and could also provide the first indications of activity. The results are expected in Q2 2023. AEF0217 has undergone an extensive preclinical proof-of-concept program using highly innovative tests to assess cognitive functions. In this context, AEF0217 demonstrated its ability to completely reverse the cognitive impairments observed in several animal models of cognitive disorders, such as Down syndrome and Fragile X syndrome, as well as in certain cognitive deficits associated with aging.

Based in Bordeaux, within the Magendie Neurocenter, Aelis Farma has a team of 23 highly qualified employees and has benefited from investments from the Nouvelle-Aquitaine Region, Inserm Transfert Initiative, Bpifrance, regional funds ACI, NACO and Aqui-invest and from IRDI Capital Investissement.

For more information: www.aelisfarma.com

ISIN: FR0014007ZB4

Ticker: AELIS

B Compartment of Euronext Paris

Disclaimer

Forward-looking statements

Some information contained in this press release are forward-looking statements, not historical data. These forward-looking statements are based on current beliefs, expectations, and assumptions, including, but not limited to, assumptions about Aelis Farma’s current and future strategy and the environment in which Aelis Farma operates. They involve known and unknown risks, uncertainties, and other factors, which may cause actual results, performance or achievements, or industry results or other events, to differ materially from those described or implied by such forward-looking statements. These risks and uncertainties include those set out and detailed in Chapter 3 “Risk Factors” of Aelis Farma’s registration document approved by the Autorité des marchés financiers on 14 January 2022 under number I.22-003.

These forward-looking statements are made only as of the date of this press release and Aelis Farma expressly disclaims any obligation or undertaking to release any updates or corrections to the forward-looking statements included in this press release to reflect any change in expectations or events, conditions or circumstances on which any such forward-looking statement is based. Forward-looking information and statements are not guarantees of future performance and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond Aelis Farma’s control. Actual results could differ materially from those described in, or implied or projected by, forward-looking information and statements.

Contacts

AELIS FARMA
Pier Vincenzo Piazza

CEO

contact@aelisfarma.com

NewCap
Dusan Oresansky/Hugo Willefert

Investor Relations

aelis@newcap.eu
+33 1 44 71 94 92

NewCap
Arthur Rouillé

Media Relations

aelis@newcap.fr
+33 1 44 71 00 15

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Global Pet Food Ingredients Market Analysis Report 2022-2027: Shift in Focus Toward Natural and Grain-Free Products & Increasing Trend of Pet Humanization to Drive Demand for Premium Pet Products – ResearchAndMarkets.com

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DUBLIN–(BUSINESS WIRE)–The “Global Pet Food Ingredients Market by Ingredient (Meat & Meat Products, Cereals, Vegetables & Fruits, Fats, Additives), Source (Animal-based, Plant Derivatives, Synthetic), Pet (Dogs, Cats, Fish), Form, and Region – Forecast to 2027” report has been added to ResearchAndMarkets.com’s offering.

The global pet food ingredients market is estimated to be valued at USD 32.2 billion in 2022. It is projected to reach USD 44.5 billion by 2027, with a CAGR of 6.7%

The market is gaining momentum as pet food ingredients continue to find increased applications across various pet species such as dogs, cats, fish and other pets such as rabbits, birds and horses. The demand for pet food ingredients is gaining significant traction in the industry, especially due to the rising focus of owners on the health and nutrition of pet animals in recent years.

Additionally, the rising innovation in the pet food ingredients market and technological advancements which are enhancing the efficiency of pet food ingredients have contributed to the growth of the market in recent years.

By ingredient, meat & meat products segment occupies the highest market share during the forecast period

Based on ingredient, meat & meat products accounted for the highest market share among all other segments owing to their rich taste and nutrition profile owing to which they have high acceptability rate among pet animals.

Meat & meat products are also effective in supporting the gut health of pets due to their higher amino acid content which is effective in controlling infections and inhibition of growth of pathogens and bacteria. Due to their high acceptability rate among pets, rich nutrition profile and desirable health benefits, they are highly preferred by pet owners, contributing to their increased demand.

By pet, dog segment is forecasted to account for the dominant segment during the forecasted period

Based on pet, the dog segment accounts for the highest market share. Dogs offer an attractive market for manufacturers of pet food ingredients owing to their varied nutritional requirements, compared to other pet animals.

A significant number of additives such as vitamins, minerals and enzymes are added to dog food products to satisfy their nutritional requirements. Dogs also account among the most preferred pets among owners, having a healthy adoption rate around the world which presents significant business opportunities for manufacturers of pet food ingredients.

By source, animal-based pet food ingredients are expected to retain their position as the dominant segment over the forecast period

Based on source, the animal-based segment is expected to account for the largest and fastest-growing segment over the forecast period because of the increasing demand among pet owners owing to their large health benefits and increased acceptability among pet animals.

They are associated with a range of health benefits such as enhancement of health of skin and coat of pet animals and are also considered effective in the inhibition and growth of pathogen and controlling infections such as bladder stones and urinary tract infections, which contributes to their increased demand in the industry.

By form, the dry segment is expected to retain its position as the dominant segment over the forecast period

Based on form, the dry segment is likely to account for the dominant and the fastest growing segment over the forecasted period.

The dry form of pet food ingredients are associated with a range of desirable characteristics such as having a richer nutritional profile, along with being highly cost-effective as compared to liquid form of pet food ingredients. They also offer higher convenience of handling during processing and storage owing to their lower moisture content which is also likely to drive their demand over the forecasted period.

The North America region accounts for the dominant market share for the pet food ingredients market during the forecast period

North America region is expected to retain its position as the dominant region for pet food ingredients market during the forecasted period.

The region’s large market share is attributed to a variety of reasons such as increase in adoption of pet animals owing to the rising pet humanization trend in the region. The pet owners in the region demonstrate a high level of awareness regarding health and nutrition of their pets, which contributes to the higher demand of pet food ingredients in the region.

The region’s growth has also been bolstered due to the presence of a significant number of major pet food ingredients manufacturing companies. The US, one of the North American countries, also accounts among the leading pet food ingredient producers, and has a large pet population which has also significantly contributed towards the growth of pet food ingredients industry in the region.

Competitive landscape

Key players in this market include BASF SE (Germany), Darling Ingredients Inc. (US), Cargill (US), Ingredion (US), DSM (Netherlands), Omega Protein Corporation (US), ADM (US), Kemin Industries, Inc. (US), Chr. Hansen Holding A/S (Denmark), and Roquette Freres (France).

Premium Insights

  • Increasing Adoption of Pets and Rising Pet Humanization Trend to Propel Growth
  • US and Animal-based Accounted for the Largest Shares in North American Market in 2021
  • Dogs Segment to Dominate During Forecast Period
  • Dry Segment to Dominate During Forecast Period
  • North America to Dominate During Forecast Period
  • Meat & Meat Products to Dominate During Forecast Period

Market Overview

Macroeconomic Factors

  • Rising Pet Adoption Among Urban Population
  • Increasing Trend of Pet Humanization to Drive Demand for Premium Pet Products

Drivers

  • Increase in Pet Expenditure with Substantial Rise in Pet Food Expenditure
  • Switch from Mass Products to Organic Pet Food Ingredients
  • Acceptance of Insect-based Protein and Oils by Pet Owners

Restraints

  • Non-Uniformity of Regulations Hindering International Trade
  • Limited Availability of Ingredients and Price Sensitivity

Opportunities

  • Use of Cannabis in Pet Food
  • Technological Advancements to Enhance Product Development
  • Shift in Focus Toward Natural and Grain-Free Products

Challenges

  • Capital Investment for Equipment
  • Threat from Counterfeit Products

Value Chain

  • Research and Product Development
  • Raw Material Sourcing
  • Production and Processing
  • Distribution
  • Marketing & Sales

Company Profiles

Key Players

  • BASF SE
  • Darling Ingredients Inc.
  • Cargill
  • Ingredion
  • DSM
  • Omega Protein Corporation
  • ADM
  • Kemin Industries, Inc.
  • Chr. Hansen Holding A/S
  • Roquette Freres

Other Players

  • Saria A/S GmbH & Co. KG
  • The Scoular Company
  • Lallemand Inc.
  • Phileo by Lesaffre
  • Labudde Group Inc.
  • Linkone Ingredient Solutions
  • 3D Corporate Solutions
  • Hydrite Chemical
  • Green Source Organics
  • Biorigin
  • Vitiva D.O.O.
  • AFB International
  • Symrise
  • Mowi ASA
  • Zinpro Corp.

For more information about this report visit https://www.researchandmarkets.com/r/8y915n

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

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Wedbush Securities’ Senior Vice President, Equity Research, Gerald, Pascarelli, CFA® Initiates Coverage on U.S. Cannabis Names CRLBF, CURLF, GTBIF & TCNNF

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LOS ANGELES–(BUSINESS WIRE)–Wedbush Securities, one of the nation’s leading independent diversified financial services providers, is pleased to announce that Equity Research Analyst, Gerald Pascarelli, CFA® is launching coverage in the U.S. Cannabis sector. On the heels of his initiation on 11 stocks in the Non-Alcoholic and Alcoholic Beverages sectors in October 2022, Gerald will expand to cover four stocks within the cannabis space: Cresco Labs Inc. (CRLBF), Curaleaf Holdings, Inc. (CURLF), Green Thumb Industries, Inc. (GTBIF) and Trulieve Cannabis Corp. (TCNNF). This initiation represents an extension into an area that was not covered by Wedbush, further expanding the scope of coverage of the firm’s Equity Research team.


Prior to joining Wedbush, Gerald served as VP of Equity Research at Cowen, Inc., where he covered both the alcoholic and non-alcoholic beverage sectors for eight years and was also an integral part of the firm’s coverage launch into the cannabis sector in 2016. In his previous role, Gerald contributed to several research white papers and cross-category consumer reports, focused on market sizing, consumer demographics and cannabis’ impact on alcoholic beverages. Prior to Cowen, Gerald spent eight years at Kingdon Capital Management, a New York-based hedge fund. He states, “As we near the end of 2022, we believe that brighter days lie ahead for the U.S. cannabis industry. I look forward to developing this new vertical of research here at Wedbush and am compelled by the current risk/reward setup for this sector of the market.”

Kevin Merritt, Wedbush Securities’ Director of Research says, “We are thrilled to have Gerald initiating in the Cannabis space as it heralds a new area of growth for our Equity Research team. As we tap into this never-before-covered space for the firm, Gerald and his team are the perfect fit to champion this new effort.”

Gerald received his Bachelor’s degree in Business Administration with a concentration in Finance from the State University of New York, at Albany. He is also a CFA® charterholder.

About Wedbush Securities

Wedbush Securities is the largest subsidiary of Wedbush Financial Services. Since its founding in 1955, Wedbush has been a leader in the financial services industry, providing our clients, both private and institutional, with a wide range of securities brokerage, wealth management, and investment banking services. Headquartered in Los Angeles, California with 100 registered offices and nearly 900 colleagues, the firm focuses on client service and financial safety, innovation, and the utilization of advanced technology.

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Contacts

Natalie A. Svider

213-688-8057

publicrelations@wedbush.com

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WeighPack Introduces High Precision Check Weigher for Tightest Tolerances

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LAS VEGAS–(BUSINESS WIRE)–#automation–WeighPack Systems’ WeightCheQ 0-250 features high precision electromagnetic force restoration (EMFR) weigh cell technology to achieve the highest tolerances possible while reading in three decimal points.


The WeightCheQ 0-250 is engineered with a weight range of 0 – 250 grams and will weigh product accurately and consistently to +/- 0.01 gram. This tight tolerance level makes it the perfect choice for check weighing pharmaceuticals, cosmetics, precious metals, cannabis pre-rolls and more.

This high-performance weigher will automatically reject product that is outside of the user’s set tolerance level and deposit it into a convenient accumulation drawer for reuse. An easy-to-read visual operation interface notifies the user when product is within the targeted weight by illuminating a green light and then changing to a red light when the target weight is out of tolerance.

The 0-250 includes a large color touchscreen, does not require compressed air and easily integrates into existing packaging lines for an immediate improvement in any quality assurance process.

This compact, modular check weigher also features heavy-duty stainless steel frame construction, food-grade belts, upstream and downstream data links, 20-recipe storage and does not require changeover parts to move between product lines.

See video of this system in action at www.weighpack.com/primary-packaging-video-library/.

For product inquiries, visit www.weighpack.com/weighpack-sales-inquiries/.

Paxiom is the national sales, system integration and service provider for the state-of-the-art packaging machine technology manufactured by WeighPack, ValTara and EndFlex. From weighing, filling, bagging and wrapping to cartoning, tray forming, case packing and palletizing, Paxiom has delivered over 7,000 packaging solutions to over 30 countries. Customers can see these solutions in person by visiting an Xperience Center in Las Vegas, Miami, Milwaukee, Montreal, Toronto or Schio, Italy.

Contacts

David Morgan, Director of Marketing, dmorgan@weighpack.com, 702-450-0808 x625

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