Triumphs and a setback in the biotech sector

The successful advancement of CDR-Life Inc.’s Phase 1 study with BI 771716, its therapeutic candidate in partnership with Boehringer Ingelheim (BI) for the treatment of geographic atrophy (GA), has triggered a milestone payment to the startup. BI 771716 is an antibody fragment-based compound. Its reduced size enables optimized retinal layer penetration to the most critical target site driving GA disease pathology. CDR-Life and BI announced the collaboration and licensing agreement in May 2020, followed by the selection of an antibody fragment-based therapeutic candidate in September 2021. The companies have executed all milestones to date. The latest achievement is the fourth milestone under the collaboration and licensing agreement between the two companies.

MoonLake Immunotherapeutics signs new partnership
MoonLake, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, has signed a three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions. The two companies will collaborate to maximize the impact of MoonLake’s nanobody-based therapy in hidradenitis suppurativa (HS) and active psoriatic arthritis (PsA), two underdiagnosed diseases with significant unmet patient needs.

MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision-making across its clinical operations, medical, marketing, and market access teams. Komodo’s data and technology applications will support MoonLake’s in-depth market research, clinical trial site selection, go-to-market strategies, and patient journey mapping – all aimed at accelerating the development of new treatment options and improving outcomes for patients with inflammatory skin and joint diseases.

Torqur enters phase 2 Clinical trials
Torqur AG, which is dedicated to advancing treatments for oncology and dermatology, has dosed the first patient in its Phase 2 clinical trial of topical bimiralisib, a dual PI3K and mTOR inhibitor. The Phase 2 study aims to assess the efficacy and safety of topically administered bimiralisib gel in 40 patients diagnosed with actinic keratosis lesions on the face, scalp, and/or back of hands. Actinic keratosis (AK) is a common pre-cancerous condition that develops on sun-damaged skin, with potential progression to invasive cutaneous squamous cell carcinoma. This multi-center, randomized, open-label study builds upon promising results from earlier preclinical and Phase 1 studies. This milestone represents a significant advancement in addressing the unmet medical needs of patients suffering from actinic keratosis.

Far from the desired endpoint
Addex Therapeutics’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals Inc., is a selective metabotropic glutamate subtype 2 (mGlu2) receptor positive allosteric modulator (PAM). Glutamate is the primary excitatory neurotransmitter in the brain and plays a key role in the initiation and spread of seizures. When activated, the mGlu2 receptor decreases the release of glutamate and, consequently, helps to maintain neurotransmitter balance. In the presence of agonist-induced activation, positive allosteric modulation of mGlu2 receptors could result in the normalization of the excessive glutamate release seen during a seizure.

The phase 2 study evaluating adjunctive ADX71149 (JNJ-40411813) administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care. The data were reported from a total of 110 evaluable patients, who each received either 50 mg or 100 mg of ADX71149 twice daily (100 mg or 200mg twice daily, respectively, for patients receiving CYP3A4 inducing anti-seizure medication) in addition to their standard dose of levetiracetam or brivaracetam and up to three other anti-seizure drugs. Adjunctive administration of ADX71149 was safe and well tolerated.

(Press release/RAN)