Accelerating the non-opioid analgesic AFA-281 clinical development with TABA-supported business development

SUMMARY AfaSci, Inc. is a clinical stage biotechnology company with 4 assets in the pipeline, one of which, AFA-281, recently completed clinical Phase I trials in healthy volunteers in the US. AFA-281 is a dual-target inhibitor of both T-type calcium channel (Cav3) and soluble epoxide hydrolase (sEH). AFA-281 produces both non-opioid analgesic and anti-inflammatory effects in rodents, and as such, is being developed for both chronic neuropathic and inflammatory pain. In the completed Phase I studies, subjects in both the single ascending dose and multiple ascending dose studies demonstrated no safety concerns, high tolerability, and dose-proportional pharmacokinetic (PK) profile. The maximum safety dose reaches the predicted human therapeutic dose range. Therefore, the completion of Phase I trials now enables a clinical proof of concept study to investigate AFA-281 as a non-opioid analgesic for chronic neuropathic pain and inflammatory pain. The company is currently financed by a combination of nondilutive funding from NIH and proceeds from a research tools & service business which AfaSci initially established while still in drug discovery phase. Afasci has therefore benefitted from excellent preclinical and clinical development expertise, but requires greater resources to support its business development and fundraising efforts. The TABA administrative supplement will provide timely support for AfaSci’s fundraising and business development efforts. We identified AfaSci weakness in business development (BD) due to lack of expertise and personnel who can dedicate to their time for BD. The company therefore wishes to engage the services of solomon Life Sciences, LLC, a biotech consulting firm. Its founder and consultant Dr. Chad Beyer has 25 years of experience in the discovery, research, and translational development of medications that treat the central nervous system and neurological disorders including various pain conditions. Dr. Beyer has a track record in being an executive for several biotech companies he founded or co-founded, fundraising of approximately $40M, and recently an Asset Purchase Agreement (APA) for KUR-101 (aka, deuterated mitragynine) for pain treatment. Dr. Beyer will lead AfaSci business development efforts in the context of reaching out to potential corporate strategic partners. In addition, he with AfaSci team support will aggressively reach out to appropriate venture capital firms and equity investors to support clinical Phase II trials in one or more indications, such as neuropathic pain and epilepsy and pipeline expanding for the future of AfaSci. With the TABA support, the BD consultant can conduct intensive fundraising. We hope to get one or more VCs and potential partner enter due diligence and more desirable providing investment and/or establishing partnership for out-licensing or co-development of our IND AFA-281. The TABA will make great impact in supporting AfaSci business development and consequently cooperate development.