bupivacaine topical spray (GTX-101) / Grace Therapeutics - LARVOL DELTA

Acasti Pharma Reports Third Quarter 2023 Operational Results (GlobeNewswire) - "Research and development expenses, net of government assistance for the three months ended December 31, 2022, totaled $2.5 million compared to $2.2 million for the three months ended December 31, 2021. Our research and development during the quarter ended December 31, 2022, was focused primarily on our clinical development programs for our...GTX-101 drug candidates."

Commercial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Acasti Pharma Inc. | Trial completion date: Nov 2022 ➔ May 2023

Trial completion date • Neuralgia • Pain

Acasti Pharma Discusses Positive Clinical Study Results for GTX-101 and GTX-102 and Upcoming Phase 3 Study for GTX-104 with The Stock Day Podcast (Yahoo Finance) - “Expanding on the GTX-101 study, ‘We announced the results back in December…Our results were very exciting. We had very positive results and met all of our primary outcome measures...the Company will now be able to enter a Phase II study in late 2023.”

New P2 trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Acasti to Host Conference Call on Tuesday, January 10, 2023 to Discuss Results from Recent Phase 1 PK Studies for GTX-101 and GTX-102 That Met All Outcome Measures (GlobeNewswire) - "Acasti Pharma Inc...announced that it will host a conference call on Tuesday, January 10, 2023 at 4:30 p.m. ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102. Both studies successfully met all target outcome measures."

P1 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Acasti Pharma Announces Preliminary Topline Results Met All Primary Outcome Measures in the Single Dose Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic Neuralgia (PHN) (GlobeNewswire) - P1 | N=48 | NCT05517486 | Sponsor: Acasti Pharma Inc. | "Acasti Pharma Inc...announced that preliminary topline results for its single-dose, pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug in the U.S., bupivacaine subcutaneous injectable, met all primary outcome measures for the study. The final clinical study report is anticipated to be received by the Company in the first half of 2023....The median time to reach the maximum concentration of bupivacaine in plasma (Tmax) following GTX-101 single-dose topical applications of 50, 100 and 200 mg ranged between 18 to 24 hours depending on dose, while the median Tmax following the subcutaneous injection of 10 mg of bupivacaine was only 23 minutes....The mean half-life (Thalf) following GTX-101 single-dose topical application of 50, 100 and 200 mg ranged between 24 to 37 hours depending on dose, suggesting a slow elimination..."

P1 data • CNS Disorders • Neuralgia • Pain

Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Acasti Pharma Inc.

New P1 trial • Neuralgia • Pain

Acasti Pharma Announces Initiation of Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic Neuralgia (GlobeNewswire) - "Acasti Pharma...announces the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy subjects. Feedback from FDA was obtained on the study protocol, and the non-objection letter was received on July 12th from Health Canada. The First-Subject, First-Dose was administered on July 26th. The PK study is the next step in the proposed 505(b)(2) regulatory pathway for GTX-101. This study is expected to be completed by the end of calendar 2022 as planned and will provide important information on the dose and dosing frequency in humans."

Trial completion date • Trial status • CNS Disorders

Acasti Pharma Reports Fiscal Year 2022 Operational Results (GlobeNewswire) - "Acasti Pharma Inc...today announced financial and operational results for the fiscal year ended March 31, 2022....GTX-101...The Company plans to initiate both a single dose study and a multiple ascending dose study in healthy human volunteers in calendar Q3, 2022. Results for these studies are expected to report out before the end of calendar 2022. Results from these pre-clinical and clinical studies are required before the Company can initiate its Phase 2 program in PHN patients, which is expected to start in early calendar 2023."

New P1 trial • New P2 trial • P1 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Acasti Pharma Announces the Issuance of Additional Patents for GTX-104 and GTX-101 (GlobeNewswire) - "In addition, the Canadian Intellectual Property Office has issued a notice of allowance for a composition of matter patent for GTX-101, a topical spray of bupivacaine targeting Postherpetic Neuralgia (PHN)....The granted patent is valid until 2036."

Patent • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Acasti Pharma Announces Patents for GTX-104 in Europe, GTX-102 in the U.S. and GTX-101 in Japan (GlobeNewswire) - "Acasti Pharma Inc...announces the following patent notifications and awards relating to the Company’s three lead drug candidates...The Japanese Patent Office granted a composition of matter patent for the Company’s topical spray GTX-101 targeting postherpetic neuralgia (PHN)....The granted patent is valid until 2036."

Patent • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Acasti Pharma Provides Business Update for the Third Quarter of Fiscal 2022 (GlobeNewswire) - "Acasti Pharma Inc...today provided a business update and announced its operating and financial results for the third quarter of its fiscal 2022 ended December 31, 2021....Research and development expenses before depreciation, amortization and stock-based compensation expenses for the three months ended December 31, 2021, totaled $2.0 million compared to $0.62 million for the three months ended December 31, 2020. The net increase was mainly attributable to increased research contract activities as the progression of work advances related to...GTX-101..."

Financing • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

"$ACST Acasti Pharma Awarded Composition-of-Matter Patents for GTX-101 in Europe, China and Mexico and for GTX-102 in Japan https://t.co/RA4hXEQCTF #patent" (@stock_titan)

Acasti Pharma Awarded Composition-of-Matter Patents for GTX-101 in Europe, China and Mexico and for GTX-102 in Japan (GlobeNewswire) - "Acasti Pharma Inc...today announces that the European Patent Office, Chinese Patent Office and the Mexican Patent Office have issued composition of matter patents for GTX-101, a novel bio-adhesive film forming topical spray formulation of bupivacaine for the treatment of Postherpetic Neuralgia (PHN)....The granted patents are valid until 2036."

Patent • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Acasti Announces Definitive Agreement to Acquire Grace Therapeutics, Inc. (GlobeNewswire) - "Acasti will acquire Grace’s entire therapeutic pipeline consisting of three unique clinical stage and multiple pre-clinical stage assets supported by an intellectual property portfolio consisting of more than 40 granted and pending patents in various jurisdictions worldwide....GTX-101: Post Herpetic Neuralgia (PHN) - Topical Spray; Clinical Stage: Phase 1 results expected 2H’22; start of Phase 2 expected 2H’22."

M&A • New P2 trial • P1 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain