Phases of clinical research

Beckley Psytech initiates Phase IIa study of 5-MeO-DMT candidate BPL-003 for Alcohol Use Disorder

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Wednesday, April 5, 2023
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Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, today announced that it has initiated a Phase IIa study ( NCT05674929 ) investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).

Key Points: 
  • Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, today announced that it has initiated a Phase IIa study ( NCT05674929 ) investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).
  • Beckley Psytech’s Phase IIa study, taking place at King’s College Hospital in London, will explore the safety, efficacy and pharmacokinetics of BPL-003 in patients diagnosed with alcohol use disorder (AUD).
  • Alcohol use disorders are estimated to affect around 237 million people across the globe , with 3 million deaths each year attributed to the harmful use of alcohol.
  • Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “There is increasing evidence demonstrating the therapeutic effect of psychedelics for substance use disorders.

Werewolf Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

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Thursday, March 23, 2023
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WATERTOWN, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • “Werewolf enters 2023 with considerable momentum following exceptional execution across our Company in 2022.
  • Financial Results for the Fourth Quarter and Full Year 2022:
    Cash position: As of December 31, 2022, cash and cash equivalents were $129.3 million, compared to $157.5 million as of December 31, 2021.
  • Net loss: Net loss was $11.9 million for the fourth quarter of 2022, compared to $17.9 million for the same period in 2021.
  • Net loss was $53.8 million for the full year 2022, compared to $50.0 million for the full year 2021.

ORYZON Announces First Patient In in FRIDA, a Phase Ib Trial With Iadademstat in Relapsed/Refractory FLT3-mutant Acute Myeloid Leukemia Patients

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Wednesday, March 15, 2023
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FRIDA (NCT05546580) is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3·mutations.

Key Points: 
  • FRIDA (NCT05546580) is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3·mutations.
  • The trial’s principal investigator is Amir Fathi, M.D., Associate Professor at Harvard Medical School and Director of the Leukemia Program at Massachusetts General Hospital.
  • In a recently finalized Phase IIa study (ALICE trial) in elder/unfit AML patients, iadademstat demonstrated robust efficacy in combination with azacitidine, with 81% ORR in the evaluable patients, of which 64% were CR/CRi.
  • Final data from the ALICE trial were presented as an oral communication at the recent 64th ASH annual conference (see here for more details).

ORYZON Announces First Patient In in NET, a Collaborative Phase II Basket Study With Iadademstat in R/R Patients With Neuroendocrine Carcinomas

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Wednesday, January 18, 2023
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The trial will assess the safety and efficacy of iadademstat in combination with paclitaxel in patients with relapsed/refractory small cell lung cancer or extrapulmonary high grade NECs.

Key Points: 
  • The trial will assess the safety and efficacy of iadademstat in combination with paclitaxel in patients with relapsed/refractory small cell lung cancer or extrapulmonary high grade NECs.
  • Neuroendocrine neoplasms are rare and heterogeneous cancers arising from neuroendocrine cells, representing 0.5% of all newly diagnosed malignancies, with a prevalence of 100,000 cases in the US.
  • Patients often rapidly develop progressive disease after first line cytotoxic chemotherapy and lack clearly efficacious second line treatment options.
  • Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU.

AltruBio to Present at Biotech Showcase™ 2023

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Thursday, January 5, 2023
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SAN FRANCISCO, Jan. 05, 2023 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today announced that its President and Chief Executive Officer Judy Chou, Ph.D. will present a corporate overview at Biotech Showcase™ 2023 taking place in San Francisco, California from January 9-11, 2023.

Key Points: 
  • SAN FRANCISCO, Jan. 05, 2023 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today announced that its President and Chief Executive Officer Judy Chou, Ph.D. will present a corporate overview at Biotech Showcase™ 2023 taking place in San Francisco, California from January 9-11, 2023.
  • The company will also share ongoing pipeline progress, clinical updates, and company developments.
  • AltruBio will also be hosting an open house at the company headquarters on January 12 by meeting appointment only.
  • Presentation details are as follows:

Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology

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Wednesday, January 4, 2023
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NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

Key Points: 
  • NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
  • The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
  • “NOV03 was specifically developed to address excess tear evaporation and alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb.
  • “These findings reinforce NOV03 as a potential new treatment option that is distinct from anti-inflammatory and immunomodulatory agents.

ORYZON Presents Final Data From Phase IIa ALICE Trial in Unfit AML Patients with First-line Treatment of Iadademstat and Azacitidine in Oral Presentation at ASH-2022

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Monday, December 12, 2022
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Of note, responses were seen in patients with a diverse array of AML mutations, suggesting a broad applicability for iadademstat in AML.

Key Points: 
  • Of note, responses were seen in patients with a diverse array of AML mutations, suggesting a broad applicability for iadademstat in AML.
  • All FLT3+ patients included in ALICE (100%; 3 out of 3) and a high proportion of TP53+ patients (75%; 6 out of 8) responded.
  • Dr. Carlos Buesa, Oryzon’s CEO, said: "These final results confirm a strong synergy between iadademstat and azacitidine in combination.
  • In a recently completed Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., ASH 2022 abstract).

iOnctura initiates Phase Ib pancreatic cancer trial of next-generation autotaxin inhibitor IOA-289

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Thursday, December 8, 2022
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“We are excited to progress clinical development of our autotaxin (ATX) inhibitor IOA-289, the second most advanced product in our pipeline,” said Catherine Pickering, PhD, CEO of iOnctura.

Key Points: 
  • “We are excited to progress clinical development of our autotaxin (ATX) inhibitor IOA-289, the second most advanced product in our pipeline,” said Catherine Pickering, PhD, CEO of iOnctura.
  • Fibrotic cancers, including pancreatic cancer, are characterized by the deposition of thick layers of extracellular matrix containing collagen fibers and pro-tumorigenic factors.
  • Pancreatic cancer (PDAC): Pancreatic ductal adenocarcinoma (PDAC) is the most common form of pancreatic cancer accounting for approximately 90% of cases.
  • There are over 50,000 diagnoses of pancreatic cancer each year in the United States and over 65,000 in the EU5.

MimiVax Announces Positive Final Data from the Phase IIa Study of SurVaxM for Newly Diagnosed Glioblastoma Published Today in the Journal of Clinical Oncology

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Thursday, December 15, 2022
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SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years.

Key Points: 
  • SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years.
  • MimiVax announces positive Phase 2A SurVaxM data in GBM, 2yr survival rate of 51%, published in JCO
    This multi-center, open label, single arm, phase IIa trial in adult patients with nGBM was approved by the institutional review boards at each of the participating hospitals [NCT02455557].
  • Of 63 patients enrolled, 60 (95.2%) remained progression-free 6 months after diagnosis to successfully reach the study primary endpoint.
  • "These promising results seen in the Phase IIa study compare favorably to the historical contemporary outcomes seen in glioblastoma.

Wellbeing Subsidiary KGK Science Submits CTA for Phase IIA Clinical Trial

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Wednesday, November 30, 2022
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This is certainly an exciting time for KGK Science and our client Nova Mentis as we await Health Canadas review of this pioneering Phase IIa psilocybin microdose study, commented Najla Guthrie, CEO of Wellbeing Digital & KGK Science.

Key Points: 
  • This is certainly an exciting time for KGK Science and our client Nova Mentis as we await Health Canadas review of this pioneering Phase IIa psilocybin microdose study, commented Najla Guthrie, CEO of Wellbeing Digital & KGK Science.
  • The CTA is subject to a 30-day review by Health Canada, and if approval is granted, KGK intends to start the clinical study in early 2023.
  • The submission of the CTA is a significant milestone in the clinical development of Nova Mentis proprietary drug called NM-1001, said William Rascan, President & CEO of Nova Mentis.
  • Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products.