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BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers

Retrieved on: 
Monday, March 25, 2024

BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.

Key Points: 
  • BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.
  • As a result, BenevolentAI’s scientists designed BEN-8744 to be not only a potent PDE10 inhibitor, but also a peripherally-restricted molecule, i.e.
  • The Phase Ia study results support this profile, showing no evidence of CNS-associated adverse events at any dose level.
  • It is anticipated that the full results from this study will be presented in a peer-reviewed forum at a later date.

Aclaris Therapeutics Announces Preliminary Topline Data from 12-Week Phase 2a Study of Oral Zunsemetinib (ATI-450) for Moderate to Severe Hidradenitis Suppurativa

Retrieved on: 
Monday, March 6, 2023

WAYNE, Pa., March 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced preliminary topline results from a 12-week, Phase 2a, multicenter, randomized, placebo-controlled clinical study to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, in patients with moderate to severe hidradenitis suppurativa (HS) (ATI-450-HS-201).

Key Points: 
  • The study did not meet its primary endpoint of change from baseline in inflammatory nodule/abscess count (AN) of zunsemetinib 50mg BID versus placebo at week 12.
  • The study also did not meet the secondary efficacy endpoints assessed in the topline data, including percentage of patients achieving HiSCR-50.
  • The placebo effect observed across all efficacy endpoints was higher than what has been observed in other published HS studies reported to date.
  • Thirty-seven patients discontinued study treatment (22 on zunsemetinib and 15 on placebo), with 15 patients discontinuing treatment due to AEs (11 on zunsemetinib and 4 on placebo).

Aclaris Therapeutics Provides R&D Update

Retrieved on: 
Tuesday, January 11, 2022

WAYNE, Pa., Jan. 11, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today provides an update on the status of certain of its clinical programs and on its research and development (R&D) operations.

Key Points: 
  • WAYNE, Pa., Jan. 11, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today provides an update on the status of certain of its clinical programs and on its research and development (R&D) operations.
  • Aclaris has bolstered its R&D group, including in the areas of clinical, preclinical and discovery, quality, pharmacology, and regulatory.
  • Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options.
  • These documents are available under the SEC Filings page of the Investors section of Aclaris website at www.aclaristx.com.

AFYX Therapeutics Presents New Study Showing Therapeutic Antibody Delivery to Oral Mucosa Using Rivelin Biodegradable Mucoadhesive Patch

Retrieved on: 
Tuesday, September 7, 2021

The preclinical study demonstrated for the first time that the companys Rivelin technology is capable of delivering biologic drugs.

Key Points: 
  • The preclinical study demonstrated for the first time that the companys Rivelin technology is capable of delivering biologic drugs.
  • AFYX has developed the Rivelin patch for delivery of therapeutics to wet tissue surfaces such as the oral mucosa.
  • The recent presentation features the first Rivelin study demonstrating the potential to deliver not only small molecules but also proteins in this case anti-TNF antibody fragments.
  • A copy of the presentation, titled Delivery of Therapeutic F(ab) antibody fragments to the Oral Mucosa Using Electrospun Patches, is available on AFYXs website at https://afyxtx.com/#publications .