Glycogen Storage Disease XIV

Adam Zamecnik @a_zamecnik Avalo drops three rare disease assets amid ongoing challenges. Credit: Shutterstock / Party people studio. Avalo Therapeutics will divest three compounds in its rare disease AVTX-800 series to AUG Therapeutics, marking a further development in the company’s tumultuous past months that included a negative trial readout and a default. The divestment is expected to be completed in Q4 2023, according to a 12 September press release. Recommended Reports Reports Chronic Heart Failure Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Pla... GlobalData Reports Acute Heart Failure Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Players GlobalData View all Companies Intelligence Avalo Therapeutics Inc Avalo, Inc. AUG Therapeutics LLC View all AUG will make an upfront payment of $150,000 for each of the three compounds bought from Avalo. This includes AVTX-801 (D-galactose), AVTX-802 (D-mannose) and AVTX-803 (L-fucose). In addition to the upfront payment, AUG will make a contingent payment of $15m if the first US Food and Drug Administration (FDA) approval is for an indication that is not a rare paediatric disease. AUG will also assume up to $150,000 of certain liabilities incurred before the agreement, based on the 12 September press release. Avalo’s AVTX-801 is a therapeutic dose of D-galactose that was developed for the treatment of the rare inherited disease phosphoglucomutase 1 (PGM1) deficiency. AVTX-803 is a therapeutic dose of L-fucose for use in leukocyte adhesion deficiency type II (LAD II), which is a different type of carbohydrate-deficient glycoprotein syndrome, based on the company’s website. Avalo first shared its plans for a potential divestment in its Q2 financial results update, shared last month. The US-based company stated that it was considering out-licensing or selling its non-core and even possibly core assets to reduce future expenses. The company already entered a non-binding letter of intent for the sale of the AVTX-800 series in July 2023. In the same month, Avalo entered a forbearance agreement with its debt lenders that followed a default. The default happened due to a material adverse change in the company’s business, per the 3 August company update. In June, Avalo announced that the Phase II PEAK study (NCT05288504) of its compound AVTX-002 (quisovalimab) in non-eosinophilic asthma patients missed its primary endpoint . While the trial did not meet the primary endpoint threshold for a reduction in asthma-related events , positive trends were observed in a patient sub-population with heightened baseline serum LIGHT levels, per a 26 June announcement.  The company announced plans to evaluate these results to shape the asset’s further development, based on the 3 August update. Beyond AVTX-002, Avalo is focused on developing its preclinical BTLA agonist fusion protein AVTX-008 in autoimmune diseases.