SNY/TBIO Move COVID-19 Vaccine Into Clinic, AVXL's PDD Study Promising, EIGR On Watch

biotech oct16

Today's Daily Dose brings you news about Eiger BioPharma's COVID-19 ILIAD study results, disappointing results of Servier/Galapagos' knee osteoarthritis drug trial, Anavex Life's Parkinson's disease dementia trial, the progress in Sanofi/Translate Bio's COVID-19 vaccine candidate MRT5500, and Lilly loosening its purse strings to bolster its pipeline with SARM1 programs for axonal degeneration.

Read on…

1. Anavex Life's Parkinson's Disease Dementia Trial Yields Promising Data

Anavex Life Sciences Corp.'s (AVXL) proof of concept phase II trial evaluating ANAVEX 2-73 in patients with Parkinson's disease dementia has yielded promising results.

Parkinson's disease dementia is a decline in thinking and reasoning that develops in many people living with Parkinson's at least a year after diagnosis. (Source: Alzheimer's Association).

The phase II trial, dubbed ANAVEX 2-73-PDD-001, involved 132 patients with Parkinson's disease dementia who were randomized to either 30mg, 50mg ANAVEX2-73, or placebo. Safety, cognitive efficacy, and sleep function were assessed during the study at week 8 and week 14.

According to the trial results, ANAVEX2-73 was safe and well-tolerated in oral doses up to 50 mg once daily and demonstrated clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis.

The company is planning to conduct a pivotal trial of ANAVEX2-73 in Parkinson's disease dementia after obtaining regulatory guidance.

There has not been a mechanistically novel medication approved for Parkinson's disease dementia in over 20 years. Novartis' Exelon was approved in 2006, to treat mild to moderate dementia associated with Parkinson's disease It was not a novel drug though as it was already approved to treat mild-to-moderate dementia associated with Alzheimer's disease.

AVXL closed Thursday's trading at $4.75, up 9.45%.

2. Eiger BioPharma's COVID-19 ILIAD Study Proves Its Mettle

Shares of Eiger BioPharmaceuticals Inc. (EIGR) jumped over 17% on Thursday, following encouraging results of an investigator-sponsored randomized trial of its drug candidate Peginterferon Lambda in outpatients with mild to moderate COVID-19.

In the study, dubbed ILIAD, which is being conducted at Toronto General Hospital, University Health Network in Toronto, Canada, involving 60 patients, the SARS-CoV-2 RNA viral load decline from baseline was significantly greater in the Peginterferon Lambda group than in the placebo group from Day 5 onwards.

By Day 7, 80% of patients in the Peginterferon Lambda group were negative for SARS-CoV-2 compared to 63% in the placebo arm.

Peginterferon Lambda, or Lambda in short, licensed by Eiger from Bristol-Myers Squibb, is a phase III-ready asset for the treatment of hepatitis delta virus.

The most advanced drug candidate in Eiger's pipeline is Lonafarnib, which is under FDA review for the proposed indication of Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathies, with a decision date set for November 20, 2020. Lonafarnib is also being evaluated in a phase III trial in hepatitis delta virus, dubbed D-LIVR.

EIGR closed Thursday's trading at $10.13, up 17.52%.

3. Lilly To Acquire Disarm Therapeutics for $1.3Bln

Eli Lilly and Company (LLY) has agreed to acquire Disarm Therapeutics, a privately-held biotechnology company developing a new class of disease-modifying therapeutics for patients with axonal degeneration, in a deal valued at $1.3 billion.

The acquisition expands Lilly's R&D efforts in pain and neurodegeneration with the addition of Disarm's preclinical SARM1 programs for axonal degeneration. Axonal degeneration, which refers to a broad range of neurological diseases, is known to cause severe sensory, motor, and cognitive symptoms.

As part of the deal, Lilly will make an upfront payment of $135.0 million to Disarm Therapeutics and up to $1.225 billion in additional future payments upon achieving regulatory and commercial milestones.

LLY closed Thursday's trading at $146.78, down 1.13%.

4. Servier/Galapagos' Knee Osteoarthritis Drug Flunks Phase II Trial

Servier and Galapagos NV's (GLPG) phase II trial with GLPG1972/S201086 in knee osteoarthritis patients, dubbed ROCCELLA, has failed to meet the primary and secondary objectives.

The study evaluated three different once-daily oral doses of GLPG1972/S201086 in 932 patients with knee osteoarthritis over 52 weeks of treatment. However, none of the doses were able to reduce cartilage loss of the central medial tibiofemoral compartment of the target knee, which was the primary objective.

There was no significant difference compared to placebo observed on secondary endpoints, including clinical outcomes, added the company.

GLPG closed Thursday's trading at $138.50, down 2.84%.

5. Sanofi/Translate Bio to Move COVID-19 vaccine Candidate into Clinic

Sanofi (SNY) and Translate Bio (TBIO) are all set to advance their COVID-19 vaccine candidate MRT5500 into a phase I/II clinical trial this quarter.

In preclinical studies, MRT5500 has demonstrated a favorable immune response profile against SARS-CoV-2. In mice, MRT5500 was tested at four dose levels namely, 0.2, 1, 5, and 10 µg per dose using a two-dose vaccination schedule, administered three weeks apart.

According to the companies, there was 100% *seroconversion at all dose levels after one administration, and a further increase in titers was observed following a second administration. (Seroconversion is the development of detectable antibodies in the blood that are directed against an infectious agent - Source: MedicineNet).

In non-human primates (NHPs), MRT5500 was assessed at three dose levels - 15, 45, and 135 µg per dose using a two-administration vaccination schedule, three weeks apart.

After the first administration, the majority of NHPs developed neutralizing antibodies reactive to the SARS-CoV-2 spike protein and those antibody titers were further enhanced after a second administration with 100% of NHPs reaching levels significantly higher than those from human convalescent sera by day 35, the companies noted.

TBIO closed Thursday's trading at $15.49, up 5.02%.

6. Stocks That Touched New Highs/Lows

Beam Therapeutics Inc. (BEAM) closed at a new high of $32.92, up 16.20%.

Kronos Bio Inc. (KRON) closed at a new high of $31.79, up 0.70%.

ClearPoint Neuro Inc. (CLPT) closed at a new high of $7.12, up 13.02%.

Dyne Therapeutics Inc. (DYN) closed at a new low of $17.16, down 2.94%.

ADC Therapeutics SA (ADCT) closed at a new low of $27.26, down 11.52%.

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