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Aclaris Therapeutics: A Potential Big Pharma Deal May Be In The Horizon

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BiotechValley Insights


  • BiotechValley Insights is initiating coverage of ACRS with a "Bullish" rating.
  • ATI-450 is a novel oral MK2 inhibitor that demonstrated comparable efficacy and superior safety over Jak inhibitors during Ph2. The oral route of administration offers a superior convenience over biological DMARDs.
  • MK2 inhibitors may be scalable to numerous autoimmune diseases; the autoimmune disease market is projected to be US$65b.
  • 2021 is a year where ACRS may have many potential catalysts lined up including potential big-pharma partnership/licensing-out and various data-readout for AD, CAPS, and COVID-19 trials.

Recommendation: Bullish

Source: Google Stock Price Data

BiotechValley Insights is initiating coverage of ACRS with a "Bullish" rating. ACRS recently had a remarkable rally after the phase 2 RA trial data readout. At this point, these are the bear and bull scenarios that can unfold during the next 6-12 months.

Bull Case:

  1. Big Pharma Partnership/Licensing out/acquisition of ACRS: 1H-2H 2021: potential 30-50% upside
  2. Positive AD, CAPS, COVID-19 data readout: Q1-Q3 2021: potential 20-30% upside
  3. Positive RA data: Q4 2021 - Q1 2022: potential 50-100% upside

Bear Case:

  1. Negative AD, CAPS, COVID-19 data readout: Q1-Q3 2021: potential 20-30% downside
  2. Additional public offering diluting shares

Company Background:


Source: William Blair Equity Research

Most of the value of the company is driven by the ATI-450 and ATI-1777. It is hard to develop conviction for ATI-1777 at this stage as it is only going through phase 1. I am going to focus primarily on ATI-450 in the report.


Mechanism of Action

Source: ACRS presentation

Targeting p38a was tried globally but constantly exhibited toxicity and lack of sustained efficacy in RA and IBD trials. The main reason for the toxicity was because P38a phosphorylates over 60 substrates and causes many unwanted side effects. To overcome this drawback, ATI-450 targets the MK2 directly.

Source: ACRS Presentation

ATI-450 has a higher selectivity toward p38a/MK2 complex than p38 or MK2 alone. In the nucleus, inactive MK2 and p38a dock in a high-affinity complex; this exhibits a binding pocket. ATI-450 binds to the wall of the pocket and prevents MK2 activation.

The scalability X-factor

MK2 drives many pro-inflammatory cytokine expressions (TNF-a, IL1B, IL6, IL8). By inhibiting the MK2 receptor, ATI-450 has a high potential to be scaled to many autoimmune diseases such as psoriasis, ulcerative colitis, Crohn's disease, and atopic dermatitis.

Source: ACRS

This article was written by

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Comments (4)

biogenius profile picture
At a MC of over 1 bil, I am convinced the market has over-factored the result of the small P2a trial in the very competitive field of RA. P2b result will not come for at least 1 year. The next catalyst is mid year with 1777 of which the result is totally unpredictable. I am long, but I would not recommend buying at this level.
biogenius profile picture
From press release, ATI-450-CAPS-201: A Phase 2a, multicenter, open-label, single-arm clinical trial to investigate the safety, tolerability, efficacy and pharmacodynamics of ATI-450 for the maintenance of remission in subjects with cryopyrin-associated periodic syndrome (CAPS) previously managed with anti-IL1 therapy. Due to the COVID-19 pandemic, subject enrollment in this trial was paused. As a result of the ongoing pandemic and given the positive preliminary topline data from the ATI-450-RA-201 trial, Aclaris has decided to focus its efforts and resources on other immuno-inflammatory diseases.
Any big Pharma candidates come to mind relative to a deal?
Nice article, thx. ACR scores are impressive for their lead candidate, as you mention. Would be nice to see a head to head vs Humira in radiographic progression data. Perhaps later on.
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