BioBiz: FDA Approves Two Oral JAK Inhibitors for Moderate-to-Severe Atopic Dermatitis;$20M Seed funding for Faeth

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Last week, the Food and Drug Administration approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) upadacitinib and abrocitinib — making them the first oral JAK inhibitors available for this indication in the United States.

The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate-to-severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate-to-severe AD: Measure Up 1 and 2 trials, led by Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.

Faeth Therapeutics, a healthcare company developing machine learning-driven precision nutrition solutions and treatment regimens to enhance cancer therapy, today announced the closing of a $20M seed financing round co-led by Khosla Ventures and Future Ventures, with participation from S2G Ventures, Digitalis, KdT Ventures, Agfunder, Cantos and Unshackled.

The financing will be used to advance Faeth’s precision nutrition platform as well as its lead candidate, an isoform-selective PI3Kα inhibitor, Serabelisb, into Phase Ib/II clinical trials this year. Faeth will also be expanding its team to further develop its MetabOS™ preclinical discovery platform and patient-facing software.

Amagma Therapeutics, a Walthham, MA-based biotechnology company developing antibody therapeutics for inflammatory diseases, announced a license option agreement with Innovent Biologics, Inc. (HKEX: 01801) (“Innovent”) for up to three enzyme specific inhibitors derived from Amagma’s proprietary SEIZMIC™ Platform.

Amagma’s SEIZMIC™ Platform (SElective Inhibition of enZymes through structural and Molecular Insights and Conformations) leverages a structure-based approach to identify highly selective antibodies which inhibit dysregulated proteases and other enzymes of interest.The collaboration will allow Innovent to access novel, first-in-class molecules for inflammatory disorders with little to no existing treatment options.

Petros Pharmaceuticals, Inc., has initiated two self-selection studies for its ED drug STENDRA® (avanafil). The results of these studies will be part of a more comprehensive data package the Company plans to submit to the U.S. Food and Drug Administration (FDA) to potentially achieve over-the-counter (OTC) status for STENDRA® (avanafil).

“These self-selections studies are a key component to the pathway for the FDA-guided OTC candidacy, review and approval process. While the process of gathering data to be shared with the FDA continues, we are enthusiastic about our progress toward providing new hope for the millions of men suffering from this condition,” commented Fady Boctor, Petros’s President and Chief Commercial Officer said in a statement.

Aqualung Therapeutics, an early stage immunotherapeutics company with an anti-inflammatory therapeutic platform for life-threatening unchecked inflammation, has closed a $2.5M convertible note fundraise led by a $1.5M investment from JSR Life Sciences, LLC. The convertible note close brings the total Aqualung funding to date to >$17M, with $14 million derived from non-dilutive capital via NIH-funded grants and an earlier successfully executed $700,000 early seed round. In addition to investments in the convertible note, JSR Life Sciences has committed an additional $1.5M to the upcoming $10M Series A capital raise.

The newly obtained convertible note funding will facilitate Aqualung’s ‘First in Human’ phase 1A safety trial in healthy human volunteers utilizing an innovative humanized eNAMPT-neutralizing ALT-100 mAb therapy. This phase 1A trial in healthy human volunteers is anticipated to start in June 2022. Aqualung has completed manufacturing of ~3500 doses of the ALT-100 mAb which are now available for this initial safety human trial and for subsequent human trials in subjects with ARDS. The new convertible note funding also allows for IND filing with the US FDA for the ARDS indication.